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Biolife Plasma Services jobs in Raleigh, NC

- 67 jobs
  • Center Manager in Training - Relocation Required

    Biolife Plasma Services 4.0company rating

    Biolife Plasma Services job in Raleigh, NC

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. **Job Description** **Senior Operations Management Trainee (Senior OMT)** **About BioLife Plasma Services** Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. _BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd._ _Equal Employment Opportunity_ Are you a senior leader interested in bringing your expertise to a place where you can feel good about the work you do? Do you want to develop new skills and set yourself up for continued growth? As a **Senior Operations Management Trainee** at BioLife, you will participate in an advanced leadership development program that will take you to our plasma centers across the country. You'll travel up to 95% of the time to learn the business while networking with supportive leaders and prepare yourself for accelerated career growth. After completing the program and obtaining a Plasma Center Operations Manager role, you'll relocate to one of BioLife's locations. **Our growth is your bright future.** Opportunities to grow as a leader are within your reach. With the incredible growth of 135+ BioLife Plasma Services centers across the U.S., the future looks bright for you. When you work at BioLife, you'll feel good knowing what you do makes a difference. **_A typical day for you may include:_** + **Continuous Learning & Development:** The expedited training program lasts approximately six months. Upon completion, you'll have 12 months to obtain a Plasma Center Manager position. During this time, you'll receive hands-on experience and have mentorship opportunities. Drive your own learning plan that covers all aspects of managing our high-volume blood plasma collection facilities. + **Team Management:** You'll use your interpersonal and communication skills to cultivate a positive environment and motivate a team of diverse individuals. Provide employee feedback, conduct performance reviews, support team members' development, participate in staff planning and recruiting, and engage and retain employees. + **Career Advancement:** Work towards obtaining a Plasma Center Operations Manager position by completing the training program, networking, and building relationships across BioLife. As you progress your career at BioLife, you'll have opportunities to open and operate brand new plasma centers. + **Supportive Teamwork:** You'll work in our fast-paced, team environment; provide operational support; conduct management training; problem-solve; and communicate with senior management. + **Exceptional Customer Service:** Retain donors by creating a positive donor experience. You may also assist with production. + **Travel Opportunities:** Learn from and network with BioLife team members across the country. You'll be able to return home every other weekend. **REQUIRED QUALIFICATIONS:** + Relocation Required upon graduation/completion of Trainee Program. You will be able to choose which location you would like to apply to. + 3-5 years of experience leading medium to large teams (20+ direct reports) + Up to 90-100% travel during the Trainee Program + Ability to walk and/or stand for the entire work shift + Willingness to travel and work at various BioLife locations across the country + Ability to work evenings, weekends, and holidays + Have a valid driver's license for the entire duration of the program + Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees + Ability to lift up to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs. + Fine motor coordination, depth perception, and ability to hear equipment from a distance + Due to potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear **PREFERRED QUALIFICATIONS:** + Associates or Bachelor's Degree + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated or high-volume retail environment + Excellent interpersonal, organizational, technical, and leadership skills **About BioLife Plasma Services** Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment. _BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd._ _Equal Employment Opportunity_ \#LI-Remote **BioLife Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. **For Location:** USA - PA - Virtual **U.S. Base Salary Range:** $80,000.00 - $110,000.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. **EEO Statement** _Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._ **Locations** USA - PA - Virtual **Worker Type** Employee **Worker Sub-Type** Regular **Time Type** Full time **Job Exempt** Yes
    $80k-110k yearly 60d+ ago
  • 1st Shift - Shipper Receiver / Sr. Shipper Receiver

    Grifols Shared Services North America, Inc. 4.2company rating

    Raleigh, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Shift: 1st Summary: The Shipper Receiver is responsible for performing the physical tasks and SAP transactions involved in the receiving, storing, and shipping of raw materials, products, equipment, and samples by unpacking and checking goods received against purchase orders or invoices, maintaining records of received goods, rejecting damaged items where necessary, and picking, packing, staging and loading temperature-sensitive finished goods for shipment to distribution partners and customers. The Sr. Shipper Receiver is responsible for performing the physical tasks and SAP transactions involved in the receiving, storing, and shipping of raw materials, products, equipment, and samples by unpacking and checking goods received against purchase orders or invoices, maintaining records of received goods, and rejecting damaged items where necessary. Processing and aggregating/de-aggregating both non-serialized and serialized customer orders, and picking, packing, staging and loading temperature-sensitive finished goods for shipment to distribution partners and customers. Also, prepares shipment documentation for export ships that is sent to the ITCL group for final export document preparation and shipment release. Primary responsibilities for role (level-specific responsibilities should be included in the chart below): ● Unload inbound freight, verify accuracy of shipper's and carriers' counts, and verify condition of goods received. Notes any discrepancies and brings to the attention of the supervisor. Sorts and labels raw materials according to procedures. ● Prepares receiving records for and delivers incoming non-inventory items to departments. Maintains files of delivery receipts for non-inventory items. ● Prepares outbound freight for shipment, including marking, strapping of cases, and paperwork preparation. Picks and stages orders, while packing according to customer request using special marking and delivery, if needed. Prepares Bills of Ladings and transportation documents. Performs TSA screening in accordance with TSA protocols and Grifols policies and procedures. Prepares and places temperature monitoring devices for shipments of temperature-sensitive products. ● Loads outbound freight. Obtains carrier's signatures for outbound goods. Sets up special pick up and delivery as requested. ● Move on-test finished goods from packaging to B100 on-test area. Move off-test finished goods to proper storage areas. Verifies count of finished goods received to off-test document. Reports discrepancies to supervisor. ● Prepare and pack frozen export paste shipments with or without dry ice in a +5 degree cold room and pack/load +15C export bulk product shipments on ocean containers. ● Performs inventory counts and periodic cycle counting activities to confirm inventory accuracy for both raw materials and finished goods. ● Maintains work area in a clean and safe condition and documents cGMP housekeeping logs. ● Safely operate fork trucks, pallet jacks, order selector, and shuttle trucks. ● Use SAP and SAP Console to perform inventory updates and serialization transactions to aggregate/de-aggregate materials at both the pallet, case, and unit level while handling finished goods shipments. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. **Additional Responsibilities - Shipper/Receiver and Senior Shipper/Receiver** + Must be familiar with plant hazardous materials procedures. + Maintains forklift batteries to ensure proper charge and water levels. + Collects empty wooden pallets from plant corridors and moves serviceable and unserviceable pallets to the warehouse; may assist with loading unserviceable pallets for removal. + Maintains warehouse housekeeping to meet GMP requirements, including skylights, docks, etc. + Handles return goods, segregating product awaiting Quality disposition or return to stock according to procedures. + Prepares and ensures accuracy of outbound freight for shipment, including marking, strapping, paperwork preparation, and picking/packing of serialized and non-serialized orders per customer specifications. + Sets up special pick-up and delivery requests as needed. + Responsible for storage, withdrawal, and delivery of hazardous raw materials throughout the facility. **Additional Senior Shipper/Receiver Responsibilities** + Performs inventory checks and cycle counts of raw materials and finished goods to ensure inventory accuracy. + Conducts pre-loading checks for containers to confirm suitability prior to loading. + Assists in training newer or less experienced employees (e.g., Shipper/Receiver) on all aspects of the job. **Knowledge, Skills, and Abilities:** + Must pass a Security Threat Analysis by TSA for this position and it is highly recommended to start the California Board of Pharmacy course. + Must possess a valid driver's license in the state in which the employee works and meet the Qualifying Driver Criteria of the Grifols Fleet Program which includes but is not limited to a 5 year Motor Vehicle Records (MVR) lookback of major driving violations. + Requires basic computer skills. + Ability to repeatedly lift up to 50lbs. + Prolonged standing during an entire shift. + Must be able to work overtime on short notice. + Must be able to perform all basic math functions. **Education-Experience requirements** : Shipper Receiver + Requires high school diploma, or equivalent. + One year of pharmaceutical, chemical, food handling/distribution and/or warehouse, logistics, production manufacturing experience in a regulated industry (FDA, USDA, NRC) obtained within the last 5 years OR Two years of warehouse experience in a non-regulated industry OR Graduation from an accredited college/university with an Associate's or Bachelor's degree in: Supply Chain/Logistics, Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Technology, Business, Teaching or a related curriculum OR Completion of the Bioworks Certification Program. + Previous forklift experience is preferred. Ability to operate a forklift and obtain forklift certification within 30 days of employment is absolutely required. Senior Shipper Receiver + Requires high school diploma, or equivalent. + Two years of pharmaceutical, chemical, food handling/distribution and/or warehouse, logistics, production manufacturing experience in a regulated industry (FDA, USDA, NRC) OR Three years of warehouse experience in a non-regulated industry. Promotion from Shipper/Receiver to Sr. Shipper/Receiver may occur at 18 months provided the employee has completed all required training and received an "exceeds expectation" on their most recent PMP. Qualified to perform all duties associated with the Shipper/Receiver role. Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree. Occupational Demands: Work is performed in a warehouse environment. Exposure to chemicals and moving machinery, kneeling, crawling and squatting. Works at heights on order selector and/or on ladders. Operates forklifts, tractors and power equipment. Personal protective equipment required such as protective eyewear, safety shoes, gloves and hearing protection. May walk; stand, bend and twists waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Repetitive foot movement. Light to moderate lifting and carrying of 15-44lbs. for 2-4 hours per day. Heavy lifting and carrying of 45lbs.and over for 2-4 hours per day with a maximum lift of 75lbs. Exposure to cold temperatures at 41 degrees F while working in the +5 cold room. Hearing acuity essential. Depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs simple and repetitive tasks that vary little each day by following a set of written or oral instructions/procedures. Maintains work pace to meet production standards. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** Learn more about Grifols (************************************** **Req ID:** 536474 **Type:** Regular Full-Time **Job Category:** LOGISTICS
    $26k-31k yearly est. 29d ago
  • Assistant/Associate Biologist

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Hours:** 12 Hour Shift ; 6:00 PM- 6:00 AM ; rotating shift; (Training will take place on 1st shift the first 1 month) Week 1: M, T, F, Sat. Week 2: Su., W, Th. **Location:** Clayton This position is responsible for performing environmental monitoring on classified areas and utility systems. Depending on area of assignment, responsibilities will include the collecting and/or testing of environmental, utility, raw material, or validation samples utilizing test methods that are specific to the assigned laboratory. Candidates must be able to follow the requirements of Grifols, Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) and complete work in a safe, accurate, and efficient manner. Responsibilities will also include performing non-routine duties, housekeeping duties, etc. as well as participating in projects such as standard and control preparations, method validations, comparison studies, etc. **Requirements** The Assistant level requires an AA or BS degree in medical technology/clinical laboratory science, or a BS degree in biology, chemistry, or related field in addition to 6-12 months of applicable laboratory experience. A background in medical technology / clinical laboratory science is preferred, as is experience in a GLP / GMP laboratory The Associate level requires an AA or BS degree in medical technology/clinical laboratory science, or a BS degree in biology, chemistry or related field in addition to 2 years of applicable laboratory experience. A background in medical technology / clinical laboratory science is preferred, as is experience in a GLP / GMP laboratory. Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** **Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton** Learn more about Grifols (************************************** **Req ID:** 536768 **Type:** Regular Full-Time **Job Category:** TECHNICAL
    $36k-78k yearly est. 15d ago
  • Logistics Business Analyst

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. *Hybrid Schedule - 3 days office, 2 days remote* The Senior Plasma Logistics Business Analyst leverages data analysis to promote transparency and provide actionable insights for decision-makers. The incumbent also works on process improvement by constructing plans and collaborating with cross-functional teams to address business issues and enhance operational efficiency. Primary Responsibilities: - Lead data analysis projects and mentor junior analysts. - Ensure data integrity and accuracy to support data-driven decision-making. - Assist the OpEx team in developing and implementing process improvement initiatives to enhance operational efficiency. - Monitor and evaluate the effectiveness of implemented initiatives and make necessary adjustments. - Facilitate training sessions to ensure team members are proficient in using data analysis tools. - Provide consultation to users and work with cross-functional teams to address business issues. - Construct forecasts, recommendations, and strategic/tactical plans based on business data and knowledge. - Identify and interpret trends and patterns in datasets to locate influences. - Produce datasets and reports for analysis using system reporting tools. - Develop and maintain comprehensive business analysis plans outlining key activities, deliverables, and timelines. - Investigate business problems and opportunities within the organization. - Support business case development by defining and presenting business and technical options that address specific business objectives. - Assess the costs, benefits, risks, and impacts of various options to help stakeholders make informed decisions. - Mentor, support and backup coverage of analyst. Ensure compliance with data governance and regulatory requirements (e.g., GxP, GDPR). Knowledge: - Advanced Data Analysis: Strong understanding of data analysis techniques, tools, and methodologies. - Business Processes: In-depth knowledge of business processes and how to optimize them. - Project Management: Solid understanding of project management principles and practices. - Industry Trends: Awareness of current industry trends and best practices in business analysis. - Plasma Logistics: Deep understanding of plasma lifecycle, cold chain logistics, and donor center operations. - Technology Integration: Familiarity with automation technologies (e.g., RPA, ML-based forecasting) and ERP systems like SAP or Kinaxis. - Compliance: Awareness of evolving regulatory and data privacy standards applicable to life sciences supply chains. Skills: - Analytical Skills: Ability to analyze complex data sets and derive actionable insights. - Communication Skills: Excellent verbal and written communication skills, including the ability to present complex information clearly. - Problem-Solving Skills: Proficiency in identifying problems, generating solutions, and making decisions. - Technical Skills: Proficiency with data analysis tools (e.g., Excel, SQL, JMP) and business intelligence software (e.g., Tableau, Power BI). Abilities: - Strategic Thinking: Ability to think strategically and influence high-level decisions. - Collaboration: Ability to work effectively with cross-functional teams and stakeholders. - Adaptability: Ability to adapt to changing business environments and priorities. Education: Bachelor's Degree: Required in Business Administration, Data Science, Economics, or a related field. Master's Degree: Preferred in Business Administration (MBA), Data Science, or a related field. Experience: - Years of Experience: 4 years of experience in business analysis or a related field required. - Leadership Experience: Proven experience in leading data analysis projects - Project Management: Demonstrated experience in managing medium to large-scale projects and initiatives. Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Occupational Demands: Work is performed in a variety of areas: centers, warehouses and office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. 10-30% travel might be required. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** **Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton** Learn more about Grifols (************************************** **Req ID:** 537088 **Type:** Regular Full-Time **Job Category:** LOGISTICS
    $67k-93k yearly est. 17d ago
  • Regulatory Affairs Surveillance Specialist

    Grifols Sa 4.2company rating

    Raleigh, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary: The Regulatory Affairs Surveillance Specialist will determine and execute actions necessary BLA Licenses supplements and other regulatory submissions to ensure that Grifols Plasma Operations is in compliance with organizations similar to or including the US Food and Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), Plasma Protein Therapeutics Association (PPTA), Commission on Laboratory Accreditation (COLA), Health Canada, and state/province and Rest of World (ROW) and other regulatory requirements, and that to meet business objectives are met. This may include licensing activities associated with plasma collection facilities, warehouse, laboratory, medical devices and any related projects for acquisitions, new product development, additions, closures or relocations, etc. May serve as a reviewer for federal submissions and may compile documents for final submission. Primary Responsibilities: * Compile and process regulatory submissions through coordination with other departments and research of internal documentation including: completing applications and forms; composing cover letters and summaries; assembling, formatting and packaging submissions in a manner to facilitate the review process; submitting and tracking submissions and providing updates on status; filing, archiving and distributing submissions electronically and in hardcopy. * Research Internal document, complete applications and forms, prepare cover letters and summaries; assemble and format applications in a manner to facilitate the review process. * Perform regulatory surveillance related to licensing activities, Source Plasma collection and medical device regulations. * Maintain up-to-date knowledge of regulatory requirements and changes in the regulatory landscape. * Communicate with U.S. and international agencies regarding regulatory requirements, obtain clarification and discuss and determine strategies for regulatory reporting. Filing as needed or required based upon projects/initiatives. * Identify and analyze compliance issues that impact regulatory compliance with the ability to propose solutions or escalate to upper management. * Review, monitor and coordinate regulatory meetings to review surveillance findings related to licensing activities, Source Plasma collection and medical devices regulations that has direct impact to the business. * Ensure management is aware on the status of submissions/applications. * Provide regulatory assessment on change controls for proposed changes. * Develop internal procedures and tools and conducts informational or training sessions for stakeholders. * May prepare and submit regulatory licensing applications to federal (U.S., Canada and ROW), state/province, local, and other regulatory authorities, as well as industry affiliates, through coordination with other departments. * Assist in preparing responses to regulatory agency inquiries * Record and maintain details of all interactions with all agencies through contact reports. * Educate and inform internal customers which may include corporate office and plasmapheresis centers regarding regulatory requirements using current regulatory citations, facts and figures to support positions. * Proofread, review and compile documents for Authorized Official signature for final submission to federal regulatory agencies. * Participate in company projects, may serve as department representative. * Responsible for ad hoc regulatory reporting (i.e. vaccine adverse events). * Maintain applicable shared mailboxes, dashboards and accounts related to licensing activities. * Perform other duties as required Additional Responsibilities: * Represent department on cross-functional project teams, as required. * Serve as team lead for departmental projects and activities, as required. * Must be able to perform Regulatory Affairs Specialist role. * May review submissions/ applications compiled by the Regulatory Affairs Specialists. * Exhibit professional behavior with internal/external business associates, reflecting positively on the company. * Understand the quality consequences of improper job performance and is aware of potential compliance defects in their area of responsibility. * Excellent attention to detail and accuracy required. * Responsible for preparing presentations. * Interface with various levels and groups throughout the organization. * Manage multiple tasks with competing demands and deadlines. * Participate in department related projects, goals and/or objectives. Knowledge, Skills, and Abilities: * Knowledge of applicable laws and regulations. understanding of the regulatory requirements for licensing applications and reporting. * Ability to work independently and initiate contacts essential to submission preparation * Ability to manage multiple and possibly conflicting priorities. * Ability to work collaboratively as part of the regulatory team to meet group objectives * Ability to review a document in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures * Ability to clearly communicate verbally and in writing and through professional conduct to achieve departmental objectives. * Ability to successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications to establish meaningful relationships. * Ability to effectively use Microsoft Office (particularly Word and Excel) and Adobe PDF to create, edit, and format documents * Ability to work with other computer systems for filing and tracking supplements and reports * Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives * Strong organizational skills with the ability to manage multiple tasks and prioritize effectively in a deadline driven environment. * Ability to plan ahead and foresee or handle possible barriers that may appear due to a project or in the day-to-day job. * Ability to elevate potential concerns/discrepancies to supervisors or management in a timely fashion. * Take initiative; look for opportunities to act and contribute to the team's success. * Ability to offer support by partnering with coworkers to promote an open, organized and challenging environment. * Ability to work independently with limited supervision and interact well in a team environment to complete duties as required. * Ability to think through problems clearly and logically. * Model and demonstrate high standards of integrity, trust, openness, and respect for others. * Ability to demonstrate openness to constructive feedback in order to improve on a continuous basis. * Make good use of unsupervised time. * Ability to connect individual responsibilities with company mission and department goals to meet business objectives while being a good representative of the company. * Embrace change and continuous improvement. Education and Experience: * Typically requires 5 years of related experience with a Bachelor's degree Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. #BiomatUSA #LI-RL1 #LI-Hybrid Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters
    $49k-69k yearly est. 60d+ ago
  • Quality Associate II

    Grifols Sa 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Shift: Day Quality Associate II/III The Quality Associate II/III will be assigned duties and responsibilities within the General Computer Systems Group in the Quality Assurance area, including SAP Quality Master Data, SAP Master Data Workflow, and Segmentation. Specific duties will include maintaining Quality Master Data in SAP for inspection plans, master inspection characteristics, sample drawing procedures and plans, maintaining Engineering Change Management in SAP, project team support for implementation of new SAP modules affecting Quality data, workflow completion of Quality data, and maintaining data integrity. The incumbent is an established and technically competent professional who independently develops and implements solutions to a variety of quality related objectives. He/she may lead teams or projects of varying scope and is often called upon by peers for his/her expertise or guidance. Demonstrates consistent application of technical knowledge and expertise, executes assignments of medium complexity, developing solutions for defined problems. The employee may be responsible for training or supervising other employees and is a fully qualified professional who requires minimal supervision. Extensive experience with SAP and the overall manufacturing process from pooling to packaged final container is preferred. Primary Responsibilities for Quality Associate II ● Coordinates SAP Quality related creations and changes in SAP and represents the department as an expert for SAP Master Data and all modules affecting Quality related data and processes. ● Consults with management to develop and implement solutions for achieving quality related objectives. ● Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals. ● Uses expertise to make independent decisions within defined areas of responsibility. ● Leads or participates on multi-disciplined project teams. Also advances technical project proposals to senior management, following through to successful completion. ● Collects and analyzes data. ● Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Incident Tracking System entries and investigation reports. ● Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply. Primary Responsibilities for Quality Associate III ● Coordinates SAP Quality related creations and changes in SAP and represents the department as an expert for SAP Master Data and all modules affecting Quality related data and processes. ● Use expertise to advise and influence the technical decisions of business units affecting SAP quality related data. ● Responsible for development, maintenance and vitality of essential Grifols technologies. ● Interacts regularly with members of management and as needed with regulatory officials. ● Lead multi-disciplined project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completion. ● May supervise or mentor employees. ● Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Incident Tracking System entries and investigation reports. ● Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply. Additional Responsibilities for Quality Associate II/III In addition to the duties described above the Quality Associate II/III may also perform the following duties based upon the business unit to which he/she is assigned: Quality Assurance General Computer Systems Management: Responsibilities may include advanced roles (such as author, reviewer, approver, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, LIMS, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality manager at business unit meetings and project meetings. Sr. Quality Associate I/II The Senior Quality Associate I/II will be assigned duties and responsibilities within the General Computer Systems Group in the Quality Assurance area, including SAP Quality Master Data, SAP Master Data Workflow, Segmentation, and Data Integrity. Specific duties will include maintaining Quality Master Data in SAP for inspection plans, master inspection characteristics, sample drawing procedures and plans, maintaining Engineering Change Management in SAP, project team support for implementation of new SAP modules affecting Quality data, workflow completion of Quality data, and maintaining data integrity. The incumbent is an established and technically competent professional who independently develops and implements solutions to a variety of quality related objectives. He/she may lead teams or projects of varying scope and is often called upon by peers for his/her expertise or guidance. Demonstrates consistent application of technical knowledge and expertise, executes assignments of medium complexity, developing solutions for defined problems. The employee may be responsible for training or supervising other employees and is a fully qualified professional who requires minimal supervision. Extensive experience with SAP and the overall manufacturing process from pooling to packaged final container is preferred. Primary Responsibilities for Sr. Quality Associate II ● Coordinates SAP Quality related creations and changes in SAP and represents the department as an expert for SAP Master Data and all modules affecting Quality related data and processes. ● Use expertise to advise and influence the technical decisions of business units affecting SAP quality related data. ● Responsible for development, maintenance and vitality of essential Grifols technologies. ● Interacts regularly with members of management and as needed with regulatory officials. ● Lead multi-disciplined project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completion. ● May supervise or mentor employees. ● Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Incident Tracking System entries and investigation reports. ● Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply. Additional Responsibilities for Sr. Quality Associate I/II In addition to the duties described above the Sr. Quality Associate I/II may also perform the following duties based upon the business unit to which he/she is assigned: Quality Assurance General Computer Systems Management: Responsibilities may include advanced roles (such as author, reviewer, approver, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, LIMS, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality manager at business unit meetings and project meetings. Requirements: Quality Associate II - must have a BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathmatics) discipline with a minium of 2 years relevant experince, or equivalent combination of education and experience. Quality Associate III - must have a BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathmatics) discipline with a minium of 3 years relevant experince, or equivalent combination of education and experience. Sr. Quality Associate I- PHD in a Life Sciences degree with minimum of 2 years relevant experience. MS in a Life Sciences degree with minimum of 4 years relevant experience. BS in a Life Sciences degree with minimum of 6 years relevant experience, or equivalent combination of education and experience. Sr. Quality Associate II- PHD in Life Sciences with minimum of 4 years relevant experience; MS in Life Sciences with minimum of 6 years relevant experience; or a BS in Life Sciences with minimum of 8 years relevant experience. Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
    $50k-79k yearly est. 25d ago
  • Medical Screener - Reception Technician (Customer Service)

    CSL Plasma 4.6company rating

    Raleigh, NC job

    Responsibilities: - Responsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process. - In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process. The screening procedures includes but are not limited to: assessing the self-administered health history, answering basic medical questions associated with the donation process, referring donors to medical staff when appropriate and performing health screening procedures such as blood pressure, pulse, weight, temperature. Performs finger stick to obtain sample to obtain donor's hematocrit and total protein levels. - Upon completion of the appropriate training, may educate new donors on the use of therapeutic products made from donated plasma. This includes explaining the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally. - May be involved in registering applicant and transfer donors based upon completion of appropriate training and operational needs of the center. - May answer the telephone and answer callers question or transfer call to appropriate staff member. - Maintains alertness and awareness to any reaction by a donor may have during or after the pheresis process and notifies appropriate staff. - Alerts Group Leader or Supervisor of donor flow issues. - Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. - Understands the policies and procedures associated with hyper immune programs at the center if applicable. - Maintains clean efficient work environment and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. - Maintains confidentiality of all personnel, donor and center information. - May be cross-trained in other areas to meet the needs of the business. - Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. - Perform other job-related duties as assigned. Qualifications: - High school diploma or equivalent required - Minimum of three (3) months experience in a clerical or customer service related position, preferably in medical or health provider environment or equivalent combination of education and experience - Must be able to perform basic math calculations Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. **Our Benefits** For more information on CSL Plasma benefits visit **************************** . **About CSL Plasma** CSL Plasma (*************************** operates one of the world's largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring (********************* , a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL (********************* , headquartered in Melbourne, Australia, employs 32,000 people. **We want CSL to reflect the world around us** At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL (**************************************************** . **Do work that matters at CSL Plasma!** R-264420 CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. ************************************************
    $43k-54k yearly est. 30d ago
  • Donor Center Technician

    Grifols Shared Services North America, Inc. 4.2company rating

    Raleigh, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Medical Reception - Donor Center Technician - We train** **You are a fit for us if you have:** + Superior customer service standards + A High School diploma or GED + Ability to work a flexible schedule + An interest in making a difference in the world + Obtains required state licensures or certifications where applicable **Donor Center Technician** Our ideal Donor Center Technician is a standout colleague who is patient, can handle multiple tasks, and adapt to a dynamic work environment. Ready to learn more? If so, keep on reading! **Primary Responsibilities:** + Conducts pre-donation medical screening. + Interaction and responsiveness to customer needs. + Assesses donor suitability and engages in set-up. + Provides appropriate feedback to ineligible donor candidates. + Ensures all donor screening information is complete. + Ensures donor confidentiality. We're Grifols, a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care. **Occupational Demands Form # 71:** Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while working in plasma freezer. Personal protective equipment required such as protective eyewear, garments, gloves and cold gear. Work is performed sitting or standing for entire shift, bending, and twisting neck and waist for 1-2 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement: may infrequently squat, crouch or sit on one's heels. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to comprehend and follow instructions to complete assigned tasks. must possess the ability to listen to and understand information and ideas presented through spoken words and sentences. must perform within the guidance of both oral or written instructions. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to their occurrence. Relates sensitive information to diverse groups. \#biomatusa Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** **Location: NORTH AMERICA : USA : NC-Raleigh:USRA2 - Raleigh NC-Garner Sta Bl-TPR** Learn more about Grifols (************************************** **Req ID:** 536497 **Type:** Regular Full-Time **Job Category:** MANUFACTURING
    $28k-37k yearly est. 35d ago
  • Administrative Associate

    Grifols Sa 4.2company rating

    Raleigh, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. This is a hybrid position with 1 day from home with an option for additional days in the future. Summary: Perform responsible administrative duties of a complex and confidential nature in support of major departmental or divisional activities to relieve supervisor of varied clerical and administrative responsibilities and to maintain efficiency of organizational operations. Job Responsibilities: * Perform advanced, diversified and confidential administrative duties by independently coordinating meetings, preparing agendas; completing a variety of non-routine tasks; coordinating department schedules, recording meeting minutes, arranging for management travel and time management; serve as primary liaison for executive and other senior management. * Support the daily operations of department, division or other organization unit assigned by assisting in meeting administrative goals and priorities for both short and long-term projects and monitoring day to day operations for efficiency and productivity. * Develop organizational unit calendar to define milestones and develop action plans to deliver milestones in a cohesive, thoroughly vetted manner which is met with great acceptance and understanding * Develop and distribute all department correspondence and information. Screen and route mail and documents; determine which to respond to, which to redirect or which to bring to supervisor's attention based on content of communication and broad knowledge of departmental programs and activities. * Organize and maintain divisional or departmental files of records, reports and correspondence required for reference and efficient operation of division or department; maintain up-to-date management and procedural manuals, directives and related records; interpret new directives, policies and regulations and inform appropriate personnel of changes * Process a considerable amount of confidential and sensitive information in support of administrative activities * Assist in preparing moderately to extremely complex reports and proposals requiring the identification of sources, compilation, analysis and evaluation of data. * Review reports received for supervisor; check and compare with source documents and bring significant items, changes, errors or omissions to the attention of the supervisor. * Assist in the preparation and management of diversified department, making suggestions and projections based on knowledge of departmental operations. * Compose letters and statements independently requiring interpretation and application of departmental policies, procedures, rules and regulations; type letters, reports and records ensuring grammatical accuracy, conformance with general policy and factual correctness. Knowledge, Skills, and Abilities: * Works on assignments that are complex in nature in which considerable judgement and initiative are required in resolving problems and making recommendations. * Capable of operating at the Board levels when asked to. * Work requires a specialized administrative support experience, arithmetic skills the ability to use automated office equipment, read difficult instructions and maintain written records. * Also need broad knowledge of administration and practices normally acquired through two to four years of post-secondary education in secretarial science or a related business field. * Ability to score at least to the 90% proficiency level on advanced office applications and procedures using the various assessment tools at Grifols. * Excellent customer service skills. * Demonstrated ability to build rapport with internal and external customers; ability to prioritize workload. * Accuracy of work; Sense of Urgency for time sensitive projects. * Ability to seek guidance when answer is not clear; Receptive to feedback from others. * Teamwork, Attendance, Professionalism, Excellent Phone Demeanor Required. * Takes on other assignments willingly; Takes on stretch projects. * Displays proficiency in MS Office Suite at an advanced level and excels/subject matter expert in at least one software app. or area. * Computer skills with test scores at least 90% on advanced level in MS Office. * Takes on other assignments willingly; Takes on stretch projects. * Makes best use of time; offers to assist others in department during down time. * Seeks to increase skills. Asks for stretch assignments. * Others see as a "go to resource". * Collaboration within department as well as within other departments. Education and Experience: * AS Degree and 5 years of relative experience showing increasing administrative responsibility or BS Degree and 2 yrs of relative experience showing increasing administrative responsibility * Working towards the Administrative Professional certification or an equivalent combination of relevant education and/or experience. This position is eligible to participate in up to 5% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us! #biomatusa #app Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-RTP:USNC0001 - RTP NC-Headquarters
    $21k-30k yearly est. 52d ago
  • QC Manager

    CSL Plasma 4.6company rating

    Holly Springs, NC job

    Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day. The QC Manager will be reporting to the Head of QC. You will work onsite at our CSL Seqirus in Holly Springs, NC location. Our benefits include an Onsite Café, 1/2 mile Walking Trail, Basketball and Tennis Courts; access to Medical, Dental, Vision, Life Insurance, 401K with a 6% match and an annual bonus; and accrued PTO, wellness days and floating holidays. Responsibilities This position is for a member of the Quality Control (QC) team in Holly Springs Influenza Vaccine manufacturing facility, supporting their specific laboratory. The position provides front line support from a compliance and technical perspective related to their department to ensure services provided to the customers are accurate and patient safety is maintained. The role will be fundamentally compliance related and includes overseeing the QC Logistics team and the group of Compliance Specialists who own deviations for the department, managing CAPAs, document revisions, providing guidance related to equipment/work orders, and ensuring compliance within the group. Oversees daily operations of the Logistics and Compliance teams, ensuring alignment with established procedures and performance expectations. Ensures timely completion of SAP Work Orders across the entire QC department. Tracks and manages Periodic Reviews in Veeva to uphold compliance with review timelines and ensure accurate updates. Oversees the change control process, internal self-inspections, and Health Authority (HA) inspections. Monitors all TrackWise and Veeva workflows (including Deviations, Change Controls, CAPAs, and Product Complaints) to ensure records progress efficiently and meet internal deadlines. Leads the response process for both formal and informal auditor inquiries, ensuring timely and thorough communication. Aligns team objectives with site-wide quality performance measures and strategic goals. Conducts regular performance reviews, provides mentorship, and develops tailored growth plans for direct reports. Actively participates in succession planning, identifies high-potential talent, and fosters team development. Leads recurring operational meetings and ensures COS-related sessions (e.g., PCTs, QA/QC huddles) are held consistently and meet SMS/COS requirements. Tracks and reports key performance indicators (KPIs) and project statuses for both teams, driving accountability and continuous improvement. Delivers clear, engaging presentations to internal teams and cross-functional groups, including contributions to LQMR (Local Quality Management Review). Liaises with non-Quality Control business units such as QA, Validation, AST, MST, etc to ensure cross-functional support is obtained when trying to meet objectives. Communicates campaign-impacting information up the organizational structure and ensures investigations are completed on time and with relevant information. Minimum Qualifications Bachelor's degree or equivalent required. Degree in a science discipline preferred. 7+ years related industry experience required Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) is required. Basic knowledge of cGMP and FDA requirements preferred. Experience with Laboratory Systems and Investigation/Deviation/CAPA writing. Excellent organizational, planning and time management skills. Strong oral, written and interpersonal communication skills. Demonstrated technical writing skills. The ability to work effectively in both a team environment and an individual contributor role. Our Benefits CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL Seqirus employee. About CSL Seqirus CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. We want CSL Seqirus to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Seqirus! Watch our ‘On the Front Line' video to learn more about CSL Seqirus
    $78k-112k yearly est. Auto-Apply 2d ago
  • Senior Associate Process Development Engineer I

    Grifols 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary: As a key member of the team, the incumbent will provide comprehensive technical and scientific expertise in the development, scale-up, transfer, and support of production processes for plasma-derived proteins. The role focuses on advanced purification unit operations, including but not limited to precipitation, filtration, chromatography, tangential flow filtration, formulation, nanofiltration, and process troubleshooting. The successful candidate will leverage their scientific knowledge and hands-on experience to contribute to the advancement of innovative therapies. Primary Responsibilities: Support developmental projects, clinical manufacturing, and commercial manufacturing. Assist in the development and execution of action plans to support departmental goals. Prepare procedures and technical reports independently, including data analysis and interpretation. Report technical results in internal and cross-functional team settings. Develop solutions to complex technical problems within the area of expertise. Design scientifically rigorous experiments, including the interpretation of results. Ability to execute experiments independently and in a team setting. Conduct laboratory and clinical production work using standard processing and analytical equipment. Identify and collect data on critical process attributes and/or critical parameters for scaling. Support the start-up and commissioning of equipment and processes and the implementation of new raw materials on-site. Maintain laboratory and clinical manufacturing facilities in accordance with procedures. Knowledge Skills and Abilities: Possess the ability to set and meet deadlines, multitask, and prioritize personal objectives based on project needs. Exhibit the ability to adapt to a changing work environment. Have experience in technical writing and effective oral communication skills. Apply scientific or engineering principles to problem-solving. Be adept at working at various process scales, ranging from bench to pilot scale. Have knowledge and experience working in a GMP environment. Takes initiative to stay current in area of specialization (e.g., chromatography, filtration) and expand knowledge base. Be self-motivated and able to work effectively in a matrixed organization. Be proficient in using the MS Office Suite. Location: Clayton, NC Shift: Day Education and Experience: Senior Associate Process Development Engineer I Level: Bachelor's degree in a relevant science or engineering field with 4+ years of relevant work experience, Associate's degree with 6+ years of experience, or an equivalent combination of education and experience. Occupational Demands for Engineer: Work is performed in a clinical and/or laboratory environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to chemicals. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits and bends neck for 4-6 hours per day. May stand and twist neck for 2-4 hours per day. Occasionally walks, bends and twists waist and squats. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-30lbs. with a maximum lift of 35 lbs. May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently works with diverse groups to obtain consensus on complex issues. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton Learn more about Grifols
    $86k-111k yearly est. 60d+ ago
  • Sr. Associate Research Scientist II

    Grifols Sa 4.2company rating

    Raleigh, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. This position is in the BioAnalytics Analytical Research group. The selected candidate will be responsible for independently designing and executing analytical methods for new projects and for investigations of licensed products. The incumbent will be expected to work effectively under general supervision and contribute to the team effort to support R&D projects. The ability to analyze and interpret data is essential. Presentation of data to and participation on cross-functional teams are required. Additional tasks associated with laboratory support will be requested as needed. The analyst may participate in development and validation of new analytical techniques following cGMP. ESSENTIAL DUTIES and RESPONSIBILITIES include the following. Other duties may be assigned. * The candidate will perform routine to technically more diverse testing and analysis with minimal assistance using modern instrumental analytical techniques including but not limited to Circular Dichroism, Capillary electrophoresis, chromatography (HPLC, UPLC, GC, IC), Multi angle light scattering, Field Flow Fractionation, Particle analysis, Gel electrophoresis, Western blotting, Isoelectric focusing, and FT-IR. * The candidate will be involved in the development and qualification or validation of analytical methods. * The candidate is expected to identify analytical techniques in the literature and adapt them for use in our laboratory and to develop new methods for analyte identification and quantification. * The candidate will perform accurate technical/GXP review of other operators work and can interpret/ understand trends in data. * The candidate will perform data analysis and publish reports. * The candidate must have strong scientific understanding of the test methods being performed as well as the intermediates/products being tested Knowledge, Skills, & Abilities: * The candidate must have experience in the use of modern instrumental analytical techniques, including but not limited to Circular Dichroism, Capillary electrophoresis, chromatography (HPLC, UPLC, GC, IC), Multi angle light scattering, Field Flow Fractionation, Particle analysis, Gel electrophoresis, Western blotting, Isoelectric focusing, and FT-IR. * The candidate must be able to recognize when to modify a standard approach to be more effective and incorporates new technology when appropriate. Frequent communication with personnel from other departments is often necessary to fulfill project assignments. * Excellent verbal and written communication skills are essential. * Self-starter with strong work ethics and the ability to exercise good judgment. * Ability to work independently with minimum supervision. * Must be proactive, results oriented, and have strong attention to detail. * Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis. * Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines. * Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment. * Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Requirements: BS with 5+ years of experience or a MS 3+ years of experience. Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology) Work is performed in a clinical and/or a laboratory environment; exposure to biological fluids with potential exposure to infectious organisms, exposure to electrical office equipment, and exposure to chemicals. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits and bends neck for 4-6 hours per day. May stand and twist neck for 2-4 hours per day. Occasionally walks, bends and twists waist and squats. Frequent hand movement with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-30lbs. with a maximum lift of 35 lbs. May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently works with diverse groups to obtain consensus on complex issues. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-RTP:[[cust_building]]
    $53k-77k yearly est. 43d ago
  • Phlebotomist II

    Octapharma Plasma 3.8company rating

    Rocky Mount, NC job

    Want to Expand your career-development potential, your ability to help donors and patients, and your access to professional opportunities? We're growing fast . [You can, too!] There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you're someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a: Phlebotomist II This is What You'll Do: Ensures total operation is compliant with state and federal regulations (e.g. FDA approved Standard Operating Procedures, OSHA, CLIA, and GMP) to maintain the highest production standards and ensure facility compliance. Maintains high level of customer service and positive donor experience in line with company values and culture. Maintains cleanliness of work area to ensure a clean and professional environment. Reviews and confirms donor identification and maintains donor confidentiality per Standard Operating Procedures. Sets up and prepares all equipment and disposable supplies for venipuncture and plasmapheresis procedure. Labels and ensures each unit and samples are labeled accurately. Execute venipunctures and plasma collection, maintaining the highest standards of quality and safety. Operates the automated plasmapheresis machines, including response and evaluation of all machine alarms and alerts, donor adverse events, document exceptions, etc. Monitor donor conditions, employing techniques to ensure donor comfort, safety, and the quality of plasma product. Maintains proper ratio to ensure donor safety and to quality of product. Disconnects donors and handles the disposal of biohazardous waste and contaminated equipment, including cleaning spills and following safety protocols. Performs daily, weekly, and monthly calibration/maintenance of automated plasmapheresis machines and removes and/or replaces equipment from service, if needed. Reports all unsafe situations and conditions to management. Maintains/stocks adequate inventory and replenish supplies on plasma carts. Responsible for mentoring Phlebotomist I and may be assigned to drive training efficiencies to ensure timeliness and compliance and may be assigned as a Designated Trainer. Responsible for troubleshooting machine alarms/alerts and perform QCs routinely (defined as daily/monthly). Partners with Quality Assurance on overall Donor Floor performance (favorable performance observations, CAPA implementations and continuous improvement initiatives). Assists with storage room organization and performs assigned tasks following the First In, First Out (FIFO) method. Performs other job-related tasks as assigned. This is What It Takes: High school diploma, or equivalent (GED) required Any specific certification or licensing based on State requirements. Minimum three (3) months' experience in a medical or health care environment or equivalent combination of education and experience preferred. Must have completed documentation of training appropriate for duties, prior to performing duties independently. Ability to speak, read, write (legibly and accurately), and understand English required. Strong customer service skills required. Ability to understand and follow written and verbal protocol required. Basic computer knowledge and skills required. Able to make accurate and complete documentation. Ability to read and interpret documents, such as safety regulations, operating and maintenance instructions and procedure manuals required. Ability to function effectively in a fast-paced environment with frequent interruptions. Demonstrated consistency and reliability (good attendance, punctual, apply full effort throughout shift, flexibility with assigned schedule) required. Ability to work daytime and evening hours, weekends, holidays, and extended shifts on a frequent basis required. Ability to perform venipunctures required. Effective communication skills required. Employee possesses enhanced collaboration and adaptability skills. Do Satisfying Work. Earn Real Rewards and Benefits. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Flexible spending account (FSA) Tuition Reimbursement Employee assistance program (EAP) Wellness program 401k retirement plan Paid time off Company paid holidays Personal time More About Octapharma Plasma Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. Interested? Learn more online and apply now at: octapharmaplasma.com And if you know someone else who'd be a great fit at Octapharma Plasma, Inc., please forward this posting along! INNER SATISFACTION. OUTSTANDING IMPACT.
    $27k-36k yearly est. 60d+ ago
  • Manager, Facilities

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Summary:** Key member of our management team responsible for facilities and production maintenance. Manage predictive, preventative and corrective maintenance efforts required to ensure efficient, reliable and uninterrupted plant operations. The successful candidate shall understand that the key priority of these organizations is to provide the highest level of service to our internal customers **Primary Responsibilities:** + Provide a leadership role ensuring employee health and safety. Monitor and drive improvements in OSHA incident rates. + Manage predictive, preventative and corrective maintenance efforts as required to improve constraint/critical equipment availability + Oversee department expense/capital budgets + Excellent leadership skills: coaching, mentoring, motivating staff of Supervisors, Schedulers and Technicians + Analyze/trend maintenance costs, prioritize improvement activities + Conduct timely/competent root cause analyses. Recommend/implement innovative, efficient and effective corrective actions resulting in stable and capable processes. + Manage vendor negotiations, including purchasing of spare parts, equipment and service contracts + Ensure department's compliance with regulatory requirements including: cGMP, OSHA, FDA, State/Local Fire, State/Local Building Codes, EPA, NEC and UL. **Minimum Requirements:** Bachelor of Science Degree in Engineering: Mechanical or Electrical preferred. Advanced degree (technical/business) a plus. 3+ years of maintenance management experience. 10+ years of experience in a manufacturing environment. Medical manufacturing (cGMP) experience a plus. **Occupational Demands:** Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** Learn more about Grifols (************************************** **Req ID:** 536321 **Type:** Regular Full-Time **Job Category:** GENERAL SERVICES
    $64k-102k yearly est. 41d ago
  • Plasma Process Data Analyst I/II

    Grifols Shared Services North America, Inc. 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **This is an hourly, entry level position with some data entry office exp needed.** **Plasma Process Data Analyst I** **Summary:** The Plasma Process Data Analyst maintains and prepares plasma yield and accountability reports; performs data entry using various software (i.e. Bioman, SAP, etc.) programs. He/she also prepares graphs, retrieves and verifies production data (yields and inventories); identifies discrepant data, yield trends, problem yields and provides analysis of yield data. **Primary responsibilities for role:** ● Maintains and generates a variety of reports (i.e. yield, trending, efficiency or KPIs, etc.) ● Enters data into database using various software (i.e. Bioman, SAP, Excel, etc.) ● Prepares graphs, collects and verifies production data (i.e. yield, inventory, etc.) ● Identifies discrepant data, yield trends, etc. ● Reviews process orders in order to determine what components (i.e. stoppers, etc.) are needed to meet production schedule ● Maintains inventory of production supplies (i.e. gowning or lab coats, operating and cleaning supplies, etc.) ● Prepare annual product reviews. ● May review Batch Production Records (BPRs) and SOPs for accuracy. ● Interacts with external vendors in order to secure components/supplies needed for the department. ● Other duties as assigned (i.e. projects, etc.) **Additional Responsibilities:** Alert Manufacturing if changes are made which impact BPRs. **Knowledge, Skills, and Abilities:** Requires the ability to analyze production data at various stages; May be required to interpret yield data; Must be able to work independently with a high degree of accuracy; May be able to detect inconsistencies, deviations and trends, etc. **Education:** High School diploma or equivalent. An associate's degree is preferred. An equivalent combination of education and experience may be considered. **Experience:** A minimum of two years of relevant experiences is required. Incumbent must have good written and verbal communication skills; the ability to analyze, proofread, and edit data; and possess excellent computer skills. **Equivalency:** Depending on the area of assignment, directly related experience or a combination of directly related education and exprience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experince , an equivalent could include 4 years of experience or a Bachelor's degree. **Plasma Process Data Analyst II** **Summary:** The Plasma Process Data Analyst II performs all duties of the Data Analyst I and performs a thorough forecast/analytic review of materials for the production and supplies needed in Manufacturing production to aid in financial audits, component inventory levels and on low/high yields that is utilized by Senior Management to make key decisions in these areas. **Primary responsibilities for role:** ● Perform all duties of a Plasma Processing Data Analyst I. ● Investigates and provides in-depth information to Sr. Management from financial reports on low/high yeilds. ● Analyzes inventory levels in SAP/quality incoming inspection and provides direction on priority of materials to be inspected /added to priority list. ● Provides memos to the investigation group to support incident investigations and to release quarantine material. ● Reconciles variances in SAP in order to be audit ready; department lead for finance audits. **Knowledge, Skills, and Abilities:** Requires the ability to analyze production data at various stages; May be required to interpret yield data; Must be able to work independently with a high degree of accuracy; May be able to detect inconsistencies, deviations and trends, etc. Strong SAP and/or excel experience. **Education:** High School diploma plus 4 years relevant experience. An associate's degree is preferred plus 2 years experience. **Equivalency:** Depending on the area of assignment, directly related experience or a combination of directly related education and exprience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experince , an equivalent could include 4 years of experience or a Bachelor's degree. Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Recruiter - Kaleena Rozier Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.** Learn more about Grifols (************************************** **Req ID:** 535651 **Type:** Regular Full-Time **Job Category:** MANUFACTURING
    $60k-87k yearly est. 44d ago
  • Associate Director Access Marketing and Reimbursement Strategy

    Grifols Sa 4.2company rating

    Raleigh, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. The Associate Director, Value Access Marketing & Reimbursement is responsible for developing and executing value messaging, pull-through tactics, and reimbursement strategies that support optimal patient and provider access across the Grifols Biopharma portfolio. This role supports the field, brand, HEOR, and Value Access teams to shape & execute key initiatives aligned with customer needs. Primary Responsibilities * Manage the execution of customer-facing and multichannel marketing promotional assets (message platforms, educational programs, conference materials, promotional campaigns, training materials, etc.) to support the overall biopharma and brand with value access customers * Partner with stakeholders to identify brand-specific pull through opportunities and ensure a clear understanding of the competitive access environment Contribute to annual brand planning, forecasting, and budgeting process for market access customer segment * Support reimbursement, coding, and coverage-related responsibilities for Medicare Part B, Centers for Medicare and Medicaid (CMS) Healthcare Common Procedure Coding System (HCPCS), and American Medical Association (AMA) Current Procedural Terminology (CPT) * Support with brand teams to expand key initiatives and strategies to the managed markets customer base, which consists of payers, GPOs, integrated health systems, specialty pharmacies, physician groups and channel partners * Develop and deploy value access propositions, reimbursement tools, and pull-through strategies * Liaise with field teams and account leads to support execution in priority segments * Partner with HEOR and clinical teams to integrate evidence into messaging * Lead competitive access positioning analysis to inform strategy and messaging * Support communication and training initiatives across internal stakeholders Additional Responsibilities * Knowledge and understanding of market access customers and the complex dynamics affecting the industry trends * Understanding of US payer market dynamics and how managed care organizations make decisions across commercial and public channels * Knowledge across multiple market access channels including payer, PBM, IDN, distribution, specialty pharmacy, GPOs * Working knowledge of legal, financial, government, manufacturing, regulatory and commercial practices within the biopharmaceutical industry * Excellent communication (written, verbal and presentation), interpersonal influencing and prioritization skills required with proven ability to influence across matrixed organizations including influencing without authority Education * Bachelors Degree Experience * Bachelor's Degree, 8+ or more years' experience in biopharmaceuticals or a combination of experience in related areas such as healthcare sales, market access, provider marketing, or patient access Equivalency * Directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. The estimated pay scale for the role based in Research Triangle Park or remote is $165,000 to $215,000 per year. Additionally, the position is eligible to participate in the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! The Associate Director/Director Market Access and Reimbursement Strategy position is eligible to be hybrid or remote. Candidates residing within 40 miles of our corporate office in RTP, NC will be required to work on-site in a hybrid capacity, in accordance with company policies. Up to 20 percent travel #LI-TN1 Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-RTP || NORTH AMERICA : USA : AZ-Glendale || NORTH AMERICA : USA : AZ-Phoenix || NORTH AMERICA : USA : AZ-Yuma || NORTH AMERICA : USA : CA - Calexico || NORTH AMERICA : USA : CA - Corona || NORTH AMERICA : USA : CA - Murrietta || NORTH AMERICA : USA : CA - Palm Springs || NORTH AMERICA : USA : CA-Bakersfield || NORTH AMERICA : USA : CA-Bellflower || NORTH AMERICA : USA : CA-Chula Vista || NORTH AMERICA : USA : CA-City of Industry || NORTH AMERICA : USA : CA-Emeryville || NORTH AMERICA : USA : CA-Fresno || NORTH AMERICA : USA : CA-Lancaster || NORTH AMERICA : USA : CA-Los Angeles || NORTH AMERICA : USA : CA-Modesto || NORTH AMERICA : USA : CA-Moreno Valley || NORTH AMERICA : USA : CA-Oakland || NORTH AMERICA : USA : CA-Orange || NORTH AMERICA : USA : CA-Reseda || NORTH AMERICA : USA : CA-Sacramento || NORTH AMERICA : USA : CA-San Carlos || NORTH AMERICA : USA : CA-San Diego || NORTH AMERICA : USA : CO-Aurora || NORTH AMERICA : USA : CO-Colorado Springs || NORTH AMERICA : USA : CO-Denver || NORTH AMERICA : USA : CO-Ft Collins || NORTH AMERICA : USA : CO-Lakewood || NORTH AMERICA : USA : DC-Washington || NORTH AMERICA : USA : DE-Newark || NORTH AMERICA : USA : DE-Wilmington || NORTH AMERICA : USA : FL-Altamonte Springs || NORTH AMERICA : USA : FL-Boca Raton || NORTH AMERICA : USA : FL-Clearwater || NORTH AMERICA : USA : FL-DeLand || NORTH AMERICA : USA : FL-Ft Myers || NORTH AMERICA : USA : FL-Ft Walton Bch || NORTH AMERICA : USA : FL-Ft. Lauderdale || NORTH AMERICA : USA : FL-Gainesville || NORTH AMERICA : USA : FL-Hollywood || NORTH AMERICA : USA : FL-Jacksonville || NORTH AMERICA : USA : FL-Kissimmee || NORTH AMERICA : USA : FL-Melbourne || NORTH AMERICA : USA : FL-Miami || NORTH AMERICA : USA : FL-Miami || NORTH AMERICA : USA : FL-Ocala || NORTH AMERICA : USA : FL-Orlando || NORTH AMERICA : USA : IN-Gary || NORTH AMERICA : USA : IN-Indianapolis || NORTH AMERICA : USA : IN-South Bend || NORTH AMERICA : USA : KS-Kansas City || NORTH AMERICA : USA : KS-Olathe || NORTH AMERICA : USA : KS-Topeka || NORTH AMERICA : USA : KS-Wichita || NORTH AMERICA : USA : MI-Benton Harbor || NORTH AMERICA : USA : MI-Detroit || NORTH AMERICA : USA : MI-Lansing || NORTH AMERICA : USA : MI-Muskegon || NORTH AMERICA : USA : MI-Saginaw || NORTH AMERICA : USA : NJ-Atlantic City || NORTH AMERICA : USA : NJ-Camden || NORTH AMERICA : USA : NJ-Cherry Hill || NORTH AMERICA : USA : NJ-Freehold || NORTH AMERICA : USA : NJ-New Brunswick || NORTH AMERICA : USA : NJ-Newark || NORTH AMERICA : USA : NJ-Trenton || NORTH AMERICA : USA : OR-Eugene || NORTH AMERICA : USA : OR-Portland || NORTH AMERICA : USA : OR-Salem || NORTH AMERICA : USA : UT-Logan || NORTH AMERICA : USA : UT-Ogden || NORTH AMERICA : USA : UT-Salt Lake City || NORTH AMERICA : USA : WI - Green Bay || NORTH AMERICA : USA : WI-Kenosha || NORTH AMERICA : USA : WI-Madison || NORTH AMERICA : USA : WI-Menasha || NORTH AMERICA : USA : WI-Milwaukee:[[cust_building]]
    $68k-104k yearly est. 22d ago
  • Center Director I

    Octapharma Plasma 3.8company rating

    Rocky Mount, NC job

    How to Maximize your opportunity to do rewarding work, your future leadership potential, and your career growth? Join an industry leader. [Become one, too!] Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role: DONOR CENTER DIRECTOR This Is What You'll Do: Oversees donor center staff and operations, including production, quality compliance, finance, HR, and IT. Acts as a liaison with all corporate functions to ensure center compliance and performance. Maintains a thorough understanding of state and federal regulations (e.g. FDA approved Standard Operating Procedures, OSHA, CLIA, and GMP) to maintain the highest production standards and ensure facility compliance. Complies with federal, state, local and company-specific regulations related to quality of product, employee and donor safety and to the proper performance of day-to-day activities. Ensures that product shipments and sample submissions are accurate and performed in accordance with shipping schedules. Maintains a professional and courteous relationship with donors that will stimulate donor retention, referrals, and production growth. Ensures projected production budget is met in both quantity and potency. Trains, develops, and manages all staff in accordance with the Human Resources and company policies and other established management guidelines and regulations. Creates an organizational environment that stimulates the morale and productivity of the work force and its leadership. This Is Who You Are: A natural leader who displays strong character and integrity People person extending to a diverse group of individuals and demographics Outgoing, personable, energetic, and enthusiastic Excited to teach, learn, and advance with a growing organization Self-motivated and willing to assume the initiative Attentive, Organized, Multi-tasking, Problem solver Profession appearance and demeanor Strong communication, organizational, planning skills. Excellent written, verbal, and interpersonal communication skills. Demonstrated proficiency with Microsoft Office. Ability to work day and evening hours, weekends, holidays, and extended shifts. This Is What It Takes: Bachelor's degree preferred. Job experience will be considered in lieu of a degree. Minimum three (3) years' management/supervisory experience. Minimum three (3) years' experience recruiting, hiring, training and managing the performance of employees. Minimum one (1) year experience with responsibility for financial management and/or budgeting. Experience working in a highly regulated industry, preferred. Do Satisfying Work. Earn Real Rewards and Benefits. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Tuition Reimbursement Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time More About Octapharma Plasma, Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. Interested? Learn more online and apply now at: octapharmaplasma.com INNER SATISFACTION. OUTSTANDING IMPACT.
    $69k-122k yearly est. 60d+ ago
  • Quality Associate II / Quality Associate III, QA Release

    Grifols Sa 4.2company rating

    Clayton, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
    $48k-69k yearly est. 25d ago
  • Sr. Operations Supervisor

    Grifols Sa 4.2company rating

    Goldsboro, NC job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary: The Senior Operations Supervisor plays a critical leadership role in the day-to-day operations of the plasma donor center. As a senior frontline leader, this role is responsible for overseeing the daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a lead resource during shifts, ensures execution of operational priorities, and provides direct support to the Center Manager in driving performance, donor satisfaction, and continuous improvement. Primary Responsibilities * Serves as acting leader in the absence of the Center Manager as assigned. Maintains the ability to perform any/all tasks within the plasma center; fulfill the role of production employees and supervisor donor flow * Oversees donor operations and supervise Operation Supervisor(s) and donor center staff during assigned shifts. This includes provide shift leadership, including staffing coordination, task assignments, break schedules, and coaching of team members. * Creates employee schedules to accommodate donor cycles. * Determines the adequacy and adjust inventory levels of all goods and supplies necessary of the operation of the donor center. Compile and submit orders to vendors to meet determined inventory levels * Keeps Center Manager informed of any irregularities within the center and provide action plans to improve and correct center deficiencies. * Supports and executes daily operational plans to achieve center performance targets related to donor throughput, quality, and productivity. * Partners with Center Manager and Quality team to identify and resolve deviations or operational concerns in real time. * Monitors donor flow and proactively address delays or service issues to ensure an exceptional donor experience. * Oversees donor floor operations and supervise operation supervisor(s) and donor center staff during assigned shifts. * Learns and maintains thorough familiarity and compliance with all state and federal regulations, U.S. Food and Drug Administration (FDA)-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP) and internal company procedures. * Supervises donor selection, plasma collection and all manufacturing records to maintain the highest production standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP. * Attends all required training sessions, staff meetings, etc. * Ensures that accurate and thorough documentation of necessary records is performed. * Under the guidance of the Center Manager assure facility is maintained in a neat and clean condition and all equipment is kept in good working order. * Submits timely and accurate reports as required by the Center Manager * Assists in the control of center donor funds as determined by the Center Manager * Participates in the onboarding, training, and cross-training of staff to support center agility and performance. * Maintains active communication with other service areas to ensure accurate documentation and quality. * Leads by example in promoting a culture of safety, teamwork, and accountability. * Reports all unsafe situations or conditions to area lead, supervisor or manager. * May be trained to repair plasma center equipment. * Assists the Center Manager in any task necessary in pursuit of company objectives. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed. Education: High school diploma or GED. Certified as a Phlebotomist, Donor Center Technician, Plasma Processor, and Designated Trainer. CPR Certified Experience: Typically requires 6 years of related experience with performing phlebotomy, donor processing, and plasma processing duties with demonstrated proficiency to handle difficult situations. Equivalency: Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree. Knowledge | Skills | Abilities Exceptional customer service skills. Proficient in speaking and writing English, with legible handwriting. Where applicable, bi-lingual skills. Ability to understand, explain, and follow SOP's and protocols. Ability to work flexible scheduling to meet business needs. Ability to perform in a highly regulated, operations intensive, high volume medical business in which the safety of donors and employees, as well as the quality of the plasma collected, are paramount. Occupational Demands Form # 73: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing functions in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves, and cold gear. Work is performed both standing for up to 4 to 6 hours per day and sitting 1 to 2 hours per day each. The position does require bending and twisting of neck up from 1 to 2 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch, or sit on one's heels on rare occasion. Infrequently bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently and within guidance of oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups. #biomatusa #app #LI-CM1 Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-Goldsboro:[[cust_building]]
    $49k-91k yearly est. 53d ago
  • Medical Screener - Reception Technician (Customer Service)

    CSL Plasma 4.6company rating

    Raleigh, NC job

    Responsibilities: • Responsible for greeting donors at the plasma collection center and conducting a series of registration procedures to verify donor suitability for the plasma pheresis process. • In compliance with Standard Operating Procedures (SOPs), assists qualified donors in completing the screening process. The screening procedures includes but are not limited to: assessing the self-administered health history, answering basic medical questions associated with the donation process, referring donors to medical staff when appropriate and performing health screening procedures such as blood pressure, pulse, weight, temperature. Performs finger stick to obtain sample to obtain donor's hematocrit and total protein levels. • Upon completion of the appropriate training, may educate new donors on the use of therapeutic products made from donated plasma. This includes explaining the screening process, the health screening tests performed, the appointment system, donation fees, center policies, proper nutrition and any other information pertinent to the donor. Ensures that all donor questions are answered timely, accurately and professionally. • May be involved in registering applicant and transfer donors based upon completion of appropriate training and operational needs of the center. • May answer the telephone and answer callers question or transfer call to appropriate staff member. • Maintains alertness and awareness to any reaction by a donor may have during or after the pheresis process and notifies appropriate staff. • Alerts Group Leader or Supervisor of donor flow issues. • Ensures the accurate recording of donor data in the electronic donor information management system as outlined in the SOPs. • Understands the policies and procedures associated with hyper immune programs at the center if applicable. • Maintains clean efficient work environment and ensures sufficient operating supplies and forms are available as needed. Follows all Health Safety & Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Promotes safety in all actions. • Maintains confidentiality of all personnel, donor and center information. • May be cross-trained in other areas to meet the needs of the business. • Bilingual skills may be required, at the discretion of the organization, to meet the needs of the business. • Perform other job-related duties as assigned. Qualifications: • High school diploma or equivalent required • Minimum of three (3) months experience in a clerical or customer service related position, preferably in medical or health provider environment or equivalent combination of education and experience • Must be able to perform basic math calculations Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Our Benefits For more information on CSL Plasma benefits visit ***************************** About CSL Plasma CSL Plasma operates one of the world's largest and most sophisticated plasma collection networks, with over 350 plasma collection centers in the U.S., Europe and China. Headquartered in Boca Raton, Florida, CSL Plasma is a subsidiary of CSL Behring, a global biotherapeutics business and a member of CSL. Plasma collected at CSL Plasma facilities is used by CSL Behring for the sole purpose of manufacturing lifesaving plasma-derived therapies for people in more than 100 countries. The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Plasma!
    $43k-54k yearly est. Auto-Apply 30d ago

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