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Quality Control Analyst jobs at Seagen

- 39 jobs
  • Quality Control Analyst (January 2026) - Veterans Evaluation Services

    Maximus, Inc. 4.3company rating

    Remote

    Description & Requirements Maximus is currently hiring for Quality Control Analysts to join our Veterans Evaluation Services (VES) team. This is a remote opportunity. The Quality Control Analyst is responsible for reviewing Medical Disability Examination ("MDE") reports and Disability Benefits Questionnaires ("DBQs") generated by medical providers for veterans evaluated on behalf of the Department of Veterans Affairs (the "VA"). A Quality Control Analyst works closely with medical providers to ensure MDE reports and DBQs are consistent with the quality and timeliness requirements of the VA. Due to contract requirements, only US Citizens or a Green Card holder can be considered for this opportunity. This class is scheduled to begin on Tuesday, January 20, 2026, no alternate start dates are available. Essential Duties and Responsibilities: * Review MDE (Medical Disability Examination) requests for consistency with the DBQ. * Review MDE reports and DBQs (Disability Benefits Questionnaires) for completeness and typographical and grammatical correctness. * Communicate with medical providers and facilitate any necessary corrections to MDE reports and DBQs prior to submission to the VA. * Verify that any special requests or necessary second reviews have been completed, consistent with the VA's preferences. * Ensure that all diagnostics requested by the medical provider have been completed, reviewed by the medical provider, and are submitted with the final report. * Perform daily queue maintenance to ensure that every case assigned has updated notes and any needed action has been taken. * Communicate with the Medical Advisory Board on cases that need additional review, may be outside the scope of the assigned medical provider's training or expertise, or has presented a problem/issue with the assigned medical provider. * Consistently achieve weekly/monthly qualitative and quantitative goals set by management and VA. * Must be willing and able to work the training schedule of 8:00 AM - 5:00 PM CT, Monday-Friday for 3-4 months with no absences required (this includes pre-planned vacations/trips/appointments etc.) * This class is scheduled to begin on Tuesday, January 20, 2026, no alternate start dates are available. * Must be willing and able to work overtime as needed * Please note upon hire, Veteran Evaluation Services (VES), a Maximus Co. will provide all necessary computer equipment that is to be utilized to fulfil the duties of your role. New hires will not be exempt from using company provided equipment. * Must currently and permanently reside in the Continental US * In accordance with SCA contract requirements, remote work must be conducted from the location specified at the time of hire. Travel is not permitted, and you are required to remain at your designated home location for all work activities. Home Office Requirements Using Maximus-Provided Equipment: * Internet speed of 20mbps or higher required (you can test this by going to (****************** * Connectivity to the internet via either Wi-Fi or Category 5 or 6 ethernet patch cable to the home router * Private work area and adequate power source Minimum Requirements * Associate degree required; Bachelor's degree preferred. * Two (2) years of Quality experience may substitute for educational requirement. * Experience in Healthcare, Quality preferred. * Intermediate knowledge of medical terminology. * Excellent written and oral communication skills. * Excellent analytical skills and attention to detail. * Excellent multi-tasking skills. * Excellent organizational and prioritization skills. * Proficient in the use of Microsoft Office Products. EEO Statement Maximus is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information and other legally protected characteristics. Pay Transparency For positions on this contract, Maximus will pay the prevailing wage rate for the location in which the employee is working, as determined by the Department of Labor. That wage rate will vary depending on locality. An applicant's salary history will not be used in determining compensation. Accommodations Maximus provides reasonable accommodations to individuals requiring assistance during any phase of the employment process due to a disability, medical condition, or physical or mental impairment. If you require assistance at any stage of the employment process-including accessing job postings, completing assessments, or participating in interviews,-please contact People Operations at applicantaccommodations@maximus.com.
    $40k-65k yearly est. 10d ago
  • Billing Quality Control Coordinator - REMOTE (Northeast)

    Labcorp 4.5company rating

    Burlington, NC jobs

    At Labcorp, you are part of a journey to accelerate life-changing healthcare breakthroughs and improve the delivery of care for all. You'll be inspired to discover more, develop new skills and pursue career-building opportunities as we help solve some of today's biggest health challenges around the world. Together, let's embrace possibilities and change lives! Billing Quality Control Coordinator - REMOTE (Northeast) The Labcorp Specialty Support team has an exciting career opportunity for a Billing Quality Control Coordinator. The purpose of this position is to work with clients and divisional employees to resolve billing issues, to increase cash, and reduce bad debt. From findings, drive corrective action plans and monitor improvement. Responsibilities Acts to address clients with high bad debt or revenue write off experience by interfacing with sales and operations to create and implement action plans for improvement. Works with the client and/or Sales to address outstanding, past due client balances and obtain billing information for items moved to third parties. Coordinate and work with Corporate Billing on customer facing initiatives to communicate and assist with the adoption of technology and tools developed to improve the account performance with regards to defects. Provide billing training to phlebotomists, Sales, and clients to ensure correct billing and prompt payment. Training to include reviewing client billing invoices, obtaining appropriate 3rd party billing information, ABNs, RPI and Medical Necessity. Problem solving by being able to zero in on specific client issues from analysis of corporate reports and other quantitative data, when requested, and maintain conversational knowledge of all client issues. Establish and maintain productive relationships with employees, peers, and senior management, crossing departments, divisions and corporate lines to establish trust and confidence in the BQCC program to resolve issues. Participate in meetings with internal departments as needed (billing, sales, client services, branch, LCM, PSCs) to update and provide information regarding billing issues and activities. Act as liaison between billing and other departments. Strong communication, both oral and written is essential to communicate with others located throughout a wide geographic area where the primary mode of communication is conference calls and email. Establish effective follow up processes. Establish systems and process to manage, analyze and act on large volume of quantitative data. Ability to prioritize projects to optimize work time. Other duties as assigned by Supervisor. Qualifications: High School Diploma or equivalent required; Associate's degree or higher preferred. Minimum three + years previous work experience in medical billing, healthcare and/or insurance claims required Experience in teaching, support, and training in customer interaction situations strongly preferred. Familiarity with medical and insurance billing requirements and regulations strongly preferred. Prior experience in teaching, support, and training in customer interaction situations strongly preferred. Knowledge of LCBS, LCLS, Labcorp LINK, and other Labcorp software strongly preferred. Strong PC and systems skills (billing and laboratory systems) and working experience with major software applications for PCs (ex: Webex, Microsoft - OneNote, Teams, Excel, etc.) strongly preferred. Good organizational skills preferred. Excellent communication skills preferred. Detail oriented preferred. Self-motivated, and independent worker preferred. Application Window Closes: 10-27-25 Salary: $47,500-60K Shift: Monday-Friday; 7:00am- 3:30pm EST This position requires candidates to reside within the Northeast Division, which includes the states of Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, New York, and Pennsylvania. Occasional travel (up to 10%) may be required for meetings, training, or collabration with other teams. We'll always give advance notice and support travel arrangements. All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here. Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.
    $47.5k-60k yearly Auto-Apply 60d+ ago
  • Temp-QC Analyst

    Alkermes 4.9company rating

    Wilmington, OH jobs

    GENERAL DESCRIPTION: The position requires the individual to perform routine/non-routine physical, chemical, and in-vitro assays of clinical, commercial, process and cleaning validation samples, and process development samples to support Manufacturing. Performs physical and/or chemical analyses of product to ensure stability. Participates in the preparation of investigations, summaries and reports. Reviews data obtained for compliance to specifications and reports abnormalities. Revises and updates standard operating procedures as needed. May perform special projects on analytical and instrument problem solving. KEY DUTIES: * Perform and record analyses as assigned on a daily basis. * Adhere to cGMP's in all work practices. * Assist in maintaining a clean, safe workplace on a daily basis. * Review peer's work as needed. * Review and revise test methods. * Write and disseminate technical data summaries and reports as needed. * Research and recommend purchase of capital equipment as needed. * Purchase laboratory supplies as needed. * Coordinate sending samples and receiving data from contract laboratories as needed. * Train other colleagues in methods and procedures. * Proactively assist other team members. SKILLS/ABILITIES: * Ability to perform routine analysis, such as wet chemistry and operate basic laboratory equipment. * Understands paperwork review process. * Ability to follow written procedures and exhibit excellent documentation practices. * Basic laboratory knowledge and skills PERSONAL ATTRIBUTES: * Proactively achieves results for the best of the organization. * Willingness to learn new things. * Ability to function in a small company atmosphere. * Ability to cope with a rapidly changing work environment. * Commitment to teamwork. * Commitment to continuous improvement in all areas. * Ability to focus attention to details and ensure high quality work. * Ability to work safely; seek out and encourage safe practices EDUCATION AND EXPERIENCE: * Bachelors Degree in Chemistry with 0-2 years of laboratory experience. Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed.
    $49k-61k yearly est. Auto-Apply 16d ago
  • Cash Compliance & Controls (C3) Intern (Charlotte, Summer 26, Hybrid)

    Compass Corporate 4.6company rating

    Charlotte, NC jobs

    Job Description Internship Program Duration: May 18th, 2026- Aug 6th, 2026 Internship Location: Charlotte, NC Internship Hours: Full-time, 8 AM to 5 PM WE ARE a family of companies delivering the best in food, hospitality, and support services. As the leading foodservice and support services company in the US, we are known for our great people, great service, and great results. If you've been hungry and away from home, chances are you've tasted our delicious food and experienced our outstanding service. Our 250,000 associates work in award-winning restaurants, corporate cafes, hospitals, schools, stadiums, arenas, convention centers, museums, and much more - in all 50 states. WE BELIEVE that each and every employee plays a key role in our growth, innovation, evolution, and legacy. We know that the next big idea can come from anyone. We encourage developing and attracting diverse talent that differentiates us as a company as we continue to raise the bar in everything we do. YOU ARE someone that is passionate about developing yourself and those around you. You enjoy being a part of a team that is collaborative, innovative, and driven to succeed. You are inspired to create lasting, memorable experiences for guests. You believe in delivering great service to guests, building strategic partnerships with clients, and continuing to learn and improve each day. You are flexible, adaptable, and are able to act decisively with little or no supervision. The Cash Compliance & Controls (C3) Intern will support a team of eleven in managing the integrity of Compass's credit card and banking transactions. This position provides exposure to both field operations and corporate leadership in a fast-paced environment with direct financial impact. The intern will gain hands-on experience with large volumes of data, reconciliations, compliance monitoring, and financial reporting processes. Responsibilities: Supporting credit card and bank reconciliations, helping ensure accuracy and timely resolution of discrepancies. Assisting with internal customer requests (audits, reconciliations, write-offs) through Remedy, providing timely and professional communication. Helping prepare and review monthly Balance Sheet reconciliations, ensuring supporting documentation is complete and accurate. Partnering with business owners and team members to reinforce compliance with company financial policies and internal controls. Assisting in the investigation of recurring exceptions or trends, helping identify potential risks and escalation points. Supporting the preparation of journal entries and related documentation during month-end close. Contributing to process improvement initiatives by documenting current processes and suggesting efficiency opportunities. Participating in special projects and ad hoc reporting as assigned. Required Qualifications: Pursuing a Bachelor's or Master's in Accounting, or related field. Strong academic record with relevant coursework. Proficiency in Microsoft Office, especially Excel. Demonstrated interest in process improvement and financial controls. Professional demeanor, strong communication skills, and attention to detail. Ability to work both independently and collaboratively in a team environment. Positive attitude and willingness to learn in a dynamic corporate setting. Preferred Qualifications: 3.2 GPA or higher. Strong verbal and written communication skills. Familiarity with IFRS and/or US GAAP. Demonstrated customer service orientation. Flexible and adaptable in a changing environment. Ability to manage multiple priorities and meet deadlines. Apply to Compass Group today! Click here to Learn More about the Compass Story At this time, employment-based visa and permanent residency sponsorship is not currently available for this position. This is a paid intern position; however, it is not eligible for benefits such as medical, dental, vision, etc. Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law. Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act. We encourage applicants with a criminal history (and driving history) to apply.
    $37k-47k yearly est. 17d ago
  • Training & Quality Intern (Charlotte, Summer 26, Hybrid)

    Compass Corporate 4.6company rating

    Charlotte, NC jobs

    Job Description Internship Program Duration: May 18th, 2026- Aug 6th, 2026 Internship Location: Charlotte, NC Internship Hours: Full-time, 8 AM to 5 PM WE ARE a family of companies delivering the best in food, hospitality, and support services. As the leading foodservice and support services company in the US, we are known for our great people, great service, and great results. If you've been hungry and away from home, chances are you've tasted our delicious food and experienced our outstanding service. Our 250,000 associates work in award-winning restaurants, corporate cafes, hospitals, schools, stadiums, arenas, convention centers, museums, and much more - in all 50 states. WE BELIEVE that each and every employee plays a key role in our growth, innovation, evolution, and legacy. We know that the next big idea can come from anyone. We encourage developing and attracting diverse talent that differentiates us as a company as we continue to raise the bar in everything we do. YOU ARE someone that is passionate about developing yourself and those around you. You enjoy being a part of a team that is collaborative, innovative, and driven to succeed. You are inspired to create lasting, memorable experiences for guests. You believe in delivering great service to guests, building strategic partnerships with clients, and continuing to learn and improve each day. You are flexible, adaptable, and are able to act decisively with little or no supervision. Training and Quality Intern Our team is currently seeking a Training and Quality intern to help support the Training & Quality - Field Accounting and/or the Field Application Specialist Team (FASTeam). This is a great opportunity to gain valuable experience and learn from a team with varied strengths and knowledge about the company. The primary role of the Training and Quality Intern position is providing training support to our accounting and healthcare field operations associates. Responsibilities: Help design, develop, and update training materials, including presentations, manuals, and e-learning content. Assist in coordinating training logistics, such as setting up venues, managing schedules, and sending invitations or reminders. Ensure proper attendance tracking and feedback collection after training sessions. Assist other Training & Quality in delivering workshops and sessions by managing technical tools, distributing handouts, or guiding participants. Coordinate with different departments to gather input on training needs. Ad hoc projects as needed Qualifications: Pursuing Bachelor's, as a rising Junior or Senior, in accounting, human resources, management, or similar undergraduate program with a minimum GPA of 3.0 Proficient in MS Office skills (Excel, Word, PowerPoint) Requirements: Excellent communication skills, both oral and written High level of attention to detail and organization with the ability to multitask Strong interpersonal and communication skills with all levels of management Proficiency regarding time and meeting target dates; Ability to work under pressure given tight deadlines Must be a quick learner, self-directed, proactive, and curious Ability to be flexible and adjust to changing factors and conditions Curiosity about the hospitality and service industry Can-do attitude Attention to detail Demonstrate awareness, understanding, and skills vital to work in a diverse environment This position is paid, but not eligible for benefits such as medical, relocation, or housing. Apply to Compass Group today! Click here to Learn More about the Compass Story At this time, employment-based visa and permanent residency sponsorship is not currently available for this position. This is a paid intern position; however, it is not eligible for benefits such as medical, dental, vision, etc. Compass Group is an equal opportunity employer. At Compass, we are committed to treating all Applicants and Associates fairly based on their abilities, achievements, and experience without regard to race, national origin, sex, age, disability, veteran status, sexual orientation, gender identity, or any other classification protected by law. Qualified candidates must be able to perform the essential functions of this position satisfactorily with or without a reasonable accommodation. Disclaimer: this job post is not necessarily an exhaustive list of all essential responsibilities, skills, tasks, or requirements associated with this position. While this is intended to be an accurate reflection of the position posted, the Company reserves the right to modify or change the essential functions of the job based on business necessity. We will consider for employment all qualified applicants, including those with a criminal history (including relevant driving history), in a manner consistent with all applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, the San Francisco Fair Chance Ordinance, and the New York Fair Chance Act. We encourage applicants with a criminal history (and driving history) to apply.
    $37k-47k yearly est. 23d ago
  • Quality Control Analyst II (QC Analytical) - 2ND SHIFT (4PM- 12AM)

    Abeona Therapeutics Inc. 4.0company rating

    Cleveland, OH jobs

    About Abeona Our Values: Patient First | Innovation | Integrity | Determination | Trust Join us in making cure the new standard of care. At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect. Company Description Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. Notably, Abeona's ZEVASKYN (prademagene zamikeracel) is the first autologous cell-based gene therapy treating wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The company's cGMP manufacturing facility in Cleveland, Ohio, is dedicated to producing ZEVASKYN. Abeona's portfolio includes adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with unmet medical needs, and their novel AAV capsids aim to improve treatment outcomes for various debilitating conditions. Position Overview The Quality Control Analyst II performs routine laboratory activities in support of Good Manufacturing Practices (GMP) testing for Quality Control (QC). Testing includes qPCR, immunoassays and cell culture-based potency assays. Supports the authorship and revision of GMP documentation. Interacts with employees internal and external to Quality Control. This position will work from 4:00 PM to 12:00 AM, Monday to Friday. Training will be on first shift for four to six months (subject to change based on company need). Essential Duties and Responsibilities * Performs other duties as assigned by management. * Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts. * Train new employees on Quality Control process flows and testing methods. * Author and revise existing Standard Operating Procedures (SOPs), testing forms and product specifications (SPCs). * Perform advanced cell culture techniques such as seeding culture dishes, transductions, and immunostaining according to approved test methods. * Completes laboratory work with precision and maintains hardcopy paperwork and electronic data in an organized manner, in compliance with company documentation practices (GDP). * Provides input to improving QC systems and procedures to improve GMP compliance. * Proactively communicates laboratory issues to supervisor or manager. * Supports laboratory investigations related to test failures, discrepancies and deviations. * Helps maintain the laboratories in a GMP compliant state, including participating in cleaning, instrument routine and preventative maintenance, logbook use, etc. Qualifications * BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 3 to 5 years of relevant experience. * Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP and/or GLP environments preferred. * Experience in cell culture, immunostaining, and drug product potency testing preferred. * Experience with DEV, CAPA and CR management preferred. * Understanding of basic scientific concepts in one or more areas above. * Experience with relevant analytical lab equipment and computers preferred. * Good mathematical and organizational skills * Ability to interact constructively with co-workers to solve problems and complete tasks * Some weekend work or late nights may be required periodically. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 20 pounds is required. Benefits Our values apply to how we view caring for each other as well. While the patient comes first, our employees are vital to making that happen, and so we strive to offer a competitive benefits package that includes: * Medical insurance coverage (multiple options to meet our employees' and their families' needs) * Dental and vision coverage * 401k match plan * Lifestyle spending account * Annual Compensation: $68,000 - $82,000 (includes shift differential) Visa Sponsorship Not Currently Available IMPORTANT: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
    $68k-82k yearly 21d ago
  • Quality Control Analyst II (QC Analytical) - 2ND SHIFT (4PM- 12AM)

    Abeona Therapeutics Inc. 4.0company rating

    Cleveland, OH jobs

    Job Description About Abeona Our Values: Patient First | Innovation | Integrity | Determination | Trust Join us in making cure the new standard of care. At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect. Company Description Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. Notably, Abeona's ZEVASKYN™ (prademagene zamikeracel) is the first autologous cell-based gene therapy treating wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The company's cGMP manufacturing facility in Cleveland, Ohio, is dedicated to producing ZEVASKYN™. Abeona's portfolio includes adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with unmet medical needs, and their novel AAV capsids aim to improve treatment outcomes for various debilitating conditions. Position Overview The Quality Control Analyst II performs routine laboratory activities in support of Good Manufacturing Practices (GMP) testing for Quality Control (QC). Testing includes qPCR, immunoassays and cell culture-based potency assays. Supports the authorship and revision of GMP documentation. Interacts with employees internal and external to Quality Control. This position will work from 4:00 PM to 12:00 AM, Monday to Friday. Training will be on first shift for four to six months (subject to change based on company need). Essential Duties and Responsibilities Performs other duties as assigned by management. Works on QC tasks of diverse scope, requiring basic knowledge of laboratory concepts. Train new employees on Quality Control process flows and testing methods. Author and revise existing Standard Operating Procedures (SOPs), testing forms and product specifications (SPCs). Perform advanced cell culture techniques such as seeding culture dishes, transductions, and immunostaining according to approved test methods. Completes laboratory work with precision and maintains hardcopy paperwork and electronic data in an organized manner, in compliance with company documentation practices (GDP). Provides input to improving QC systems and procedures to improve GMP compliance. Proactively communicates laboratory issues to supervisor or manager. Supports laboratory investigations related to test failures, discrepancies and deviations. Helps maintain the laboratories in a GMP compliant state, including participating in cleaning, instrument routine and preventative maintenance, logbook use, etc. Qualifications BS in biochemistry, biology, microbiology, molecular biology or other relevant discipline with 3 to 5 years of relevant experience. Experience and knowledge in the pharmaceutical and/or biotech industry within a GMP and/or GLP environments preferred. Experience in cell culture, immunostaining, and drug product potency testing preferred. Experience with DEV, CAPA and CR management preferred. Understanding of basic scientific concepts in one or more areas above. Experience with relevant analytical lab equipment and computers preferred. Good mathematical and organizational skills Ability to interact constructively with co-workers to solve problems and complete tasks Some weekend work or late nights may be required periodically. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 20 pounds is required. Benefits Our values apply to how we view caring for each other as well. While the patient comes first, our employees are vital to making that happen, and so we strive to offer a competitive benefits package that includes: Medical insurance coverage (multiple options to meet our employees' and their families' needs) Dental and vision coverage 401k match plan Lifestyle spending account Annual Compensation: $68,000 - $82,000 (includes shift differential) Visa Sponsorship Not Currently Available IMPORTANT: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
    $68k-82k yearly 21d ago
  • QC Scientist

    Alkermes 4.9company rating

    Wilmington, OH jobs

    Background Lead Team in project Coordination and support Coordinate and support Tech Services Projects, which include: Method Validations and optimizations New technologies and equipment Assist in the identification of new testing technologies and equipment to meet evolving regulatory requirements. Support regulatory audits. Write protocols and execute method verification/validation/qualification/ transfers Write, execute laboratory investigations for out of specifications and out of trend results Point person for higher level meetings / projects such as CMC Team support. Write documents (SOPs, specifications, technical reports) Execute, oversee instrument qualification as necessary. Implement continuous improvement activities to maximize the resources available Write change controls and work orders for systems and instrumentation changes Review data as needed utilizing LIMS, SAP and SLIM Troubleshooting of technical procedures, methodology and instrumentation Data entry for testing results following GMP regulations Review tests results for other analysts Train new analysts and document training Provide technical support to new analysts Participate in non-routine projects, validations and method development to meet departmental and individual goals Review SOPs, product specifications and controlled forms to comply with USP, EP, JP and CP regulations Maintain the laboratory operations in compliance with industry regulations Maintaining inventory of material and reagents for technical services The successful candidate will be responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills. Qualifications BSc In science related field with (min) 10+ years' experience in pharmaceutical manufacturing Able to work autonomously, receiving general instructions on new assignments. Strong technical knowledge of microbiological / Chemistry test instrumentation and method development / validation including software/computer system validation. Preferred: Oral Solid Dose knowledge Experience with the execution and validation of test methods for sterile and non-sterile drugs, their raw materials, components and in-process testing. This includes the methods described in USP Chapters and relevant informational chapters. Knowledge of current compendia requirements. Excellent organizational, planning and scheduling skills: Capable of managing/coordinating multiple projects and priorities in a dynamic environment while maintaining a professional demeanor. Critical, Fact-Based Decision Making: Demonstrates a systematic approach to problem solving; considers all relevant facts & data when making decisions; applies previous experience & best practices to new situations. Personally Accountable: Owns the results of their individual actions & team activities. Ability to learn from mistakes & holds a strong belief in continuous improvements, both personally & professionally. Agility: Able to quickly change direction when business priorities or customer requirements change; exhibits a high level of flexibility when confronted with new or unexpected circumstances Good verbal and written communication skills; confident presenter, clear, concise technical writer. Familiar with common MS Office software packages. Personal Attributes Motivated self-starter Team player Committed to quality Well organized, efficient worker Good problem solver Critical, analytical thinker Manages multiple duties and projects Creative, innovative thinker Easily adaptable to change Brings closure to work in a timely manner #LI-RS1 #LI-Onsite
    $57k-76k yearly est. Auto-Apply 22d ago
  • QC Scientist - Microbiology

    Alkermes 4.9company rating

    Wilmington, OH jobs

    Background * Lead Team in project Coordination and support * Coordinate and support Tech Services Projects, which include: * Method Validations and optimizations * New technologies and equipment * Assist in the identification of new testing technologies and equipment to meet evolving regulatory requirements. * Support regulatory audits. * Write protocols and execute method verification/validation/qualification/ transfers * Write, execute laboratory investigations for out of specifications and out of trend results * Point person for higher level meetings / projects such as CMC Team support. * Write documents (SOPs, specifications, technical reports) * Execute, oversee instrument qualification as necessary. * Implement continuous improvement activities to maximize the resources available * Write change controls and work orders for systems and instrumentation changes * Review data as needed utilizing LIMS, SAP and SLIM * Troubleshooting of technical procedures, methodology and instrumentation * Data entry for testing results following GMP regulations * Review tests results for other analysts * Train new analysts and document training * Provide technical support to new analysts * Participate in non-routine projects, validations and method development to meet departmental and individual goals * Review SOPs, product specifications and controlled forms to comply with USP, EP, JP and CP regulations * Maintain the laboratory operations in compliance with industry regulations * Maintaining inventory of material and reagents for technical services * The successful candidate will be responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills. Qualifications * BSc In science related field with (min) 10+ years' experience in pharmaceutical manufacturing * Able to work autonomously, receiving general instructions on new assignments. * Strong technical knowledge of microbiological / Chemistry test instrumentation and method development / validation including software/computer system validation. Preferred: Oral Solid Dose knowledge * Experience with the execution and validation of test methods for sterile and non-sterile drugs, their raw materials, components and in-process testing. This includes the methods described in USP Chapters and relevant informational chapters. * Knowledge of current compendia requirements. * Excellent organizational, planning and scheduling skills: Capable of managing/coordinating multiple projects and priorities in a dynamic environment while maintaining a professional demeanor. * Critical, Fact-Based Decision Making: Demonstrates a systematic approach to problem solving; considers all relevant facts & data when making decisions; applies previous experience & best practices to new situations. * Personally Accountable: Owns the results of their individual actions & team activities. Ability to learn from mistakes & holds a strong belief in continuous improvements, both personally & professionally. * Agility: Able to quickly change direction when business priorities or customer requirements change; exhibits a high level of flexibility when confronted with new or unexpected circumstances * Good verbal and written communication skills; confident presenter, clear, concise technical writer. * Familiar with common MS Office software packages. Personal Attributes * Motivated self-starter * Team player * Committed to quality * Well organized, efficient worker * Good problem solver * Critical, analytical thinker * Manages multiple duties and projects * Creative, innovative thinker * Easily adaptable to change * Brings closure to work in a timely manner #LI-RS1 #LI-Onsite
    $57k-76k yearly est. Auto-Apply 22d ago
  • Temp-QA Associate

    Alkermes 4.9company rating

    Wilmington, OH jobs

    This function is responsible for supporting the daily activities related to the investigations of product complaints. Functions include investigating, batch record review, discrepancy identification, logbook review, and TrackWise Digital trending. This function manages events with Senior Associate for approval of the complaint records. The position will perform general QA work, using their ability as a skilled contributor in completing tasks where judgement is required in resolving problems and making recommendations. Works on problems of a diverse scope where analysis and problem solving is required. Receives general oversight and guidance on approaches to complete project related tasks. Applies job related skills and understanding of policies and standards in completing tasks. Essential Functions * Authority to approve written procedures and other documents * Develop Standard Operating Procedures and other quality related documents. * Evaluation of batch manufacturing records and testing records * Follow-up on preventive and corrective actions associated with deviations * Interact with plant personnel to insure CGMP compliance. * Prepare and maintain trend analysis * Provides back up for other QA and plant site personnel as appropriate. * The monitoring of compliance with the requirement of GMP * Investigate complaints Required Education and Experience * Requires a bachelor's degree in a scientific discipline or equivalent experience. Competencies * Working knowledge of US Drug Product GMP requirements and associated guidelines. * Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues. * Ability to increase others knowledge of US end European GMP regulations and guidance. * Strong written and oral communication skills. * Experience in administration of quality systems for drug product manufacturing and quality control operations. * Strong written and oral communication skills. * Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks. * Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others * Good computer skills. * Good work ethic, dependable, punctual, and flexible. * Good motivator of personnel. * Good team player with a can-do attitude. * Can get things done on the basis of influence. * Can work in a fast-paced environment with multiple issues open simultaneously. * Highly organized. * Attention to detail. * Identifies opportunities to improve and contributes to problem solving.
    $55k-65k yearly est. Auto-Apply 10d ago
  • QC Laboratory Specialist (Mentor, OH, US, 44060)

    Steris Corporation 4.5company rating

    Mentor, OH jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The QC Laboratory Specialist is in our Mentor, OH location responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This QC Laboratory Specialist is responsible for performing quality inspection in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to testing raw material, in-process, and finished goods using the various analytical instrumentation (i.e. HPLC, FTIR and/or UV Spectrophotometers) and with supervision to perform failure investigation. This position requires working onsite in our Mentor, OH location. The hours for this role are Monday through Thursday 6:00 am to 3:30pm and Fridays 6:00 am to 10:00 am. What You'll do as a QC Laboratory Specialist * Decontaminates, cleans, and sterilizes glassware and other containers. * Monitors and maintains laboratory equipment including calibration. * Prepares media and reagents. * Performs routine product and raw material testing of samples. * Performs product and raw material testing of samples. * Prepares reagents, standard solutions, equipment for use, etc. * Recognizes and communicates unexpected results in a timely manner and completes Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials. * Writes and revises standard operating procedures (SOPs) under supervisor's direction, using Quality software to change, submit and review documents. * Participates in Investigations (complaints, failure, calibrations, equipment, etc.). The Experience, Skills and Abilities Needed Required: * Bachelor's degree in biology, chemistry or related technical field. * In lieu of a Bachelor's degree, an Associates' degree in biology, chemistry or related technical field, and a minimum of four years' experience in a laboratory environment is required, preferably in a regulated industry (i.e. FDA / ISO13485). Other: * Ability to work in a fast-paced environment with strict deadlines. * Make recommendations on improvements to test methods and procedures. * Make decisions on experimental steps and data analysis within defined parameters and guidelines. * Recognize and communicates unexpected experimental results. * Interpret data with direction. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future. Here is just a brief overview of what we offer: * Market Competitive pay * Extensive Paid Time Off and added Holidays * Excellent Healthcare, Dental and Vision benefits * Long- and Short-Term Disability coverage * 401(k) with a company match * Maternity and Paternity Leave * Additional add- on benefits / discounts for programs such as Pet Insurance * Tuition Reimbursement and continuing education programs * Excellent opportunities for advancement in a stable long-term career #LI-MO1 #LI- Onsite Pay range for this opportunity is $43,000 to $55,000. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $43k-55k yearly 18d ago
  • Quality Control Laboratory Specialist -2nd Shift (Mentor, OH, US, 44060)

    Steris Corporation 4.5company rating

    Mentor, OH jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The QC Laboratory Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This position is responsible for performing quality inspection in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to testing raw material, in-process, and finished goods using the various analytical instrumentation (i.e. HPLC, GC) and with supervision perform failure investigation. This is a second shift position. Will train Monday - Friday 2:00pm-10:30pm. Will move to Monday - Friday 4:00pm-12:30am when training is complete. What You'll Do as a Quality Control Lab Specialist Decontaminates, cleans, and sterilizes glassware and other containers. Monitors and maintains laboratory equipment including calibration. Prepares media and reagents. Performs routine product and raw material testing of samples. Performs product and raw material testing of samples. Prepares reagents, standard solutions, equipment for use, etc. Recognizes and communicates unexpected results in a timely manner and completes Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials. The Experience, Skills and Abilities Needed Required: * Associate degree * Minimum four (4) years experience relevant lab testing in a regulated environment (i.e. FDA/ISO 13485). Will accept less years of experience and lab testing in an academic setting with Bachelor degree. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer: * Market Competitive Pay * Extensive Paid Time Off and (9) added Holidays * Excellent Healthcare, Dental and Vision Benefits * Long/Short Term Disability Coverage * 401(k) with a company match * Maternity and Paternity Leave * Additional add-on benefits/discounts for programs such as Pet Insurance * Tuition Reimbursement and continued education programs * Excellent opportunities for advancement in a stable long-term career #LI-KL1 Pay range for this opportunity is $44,412.50 - $54,862.50. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $44.4k-54.9k yearly 18d ago
  • QC Laboratory Specialist

    Steris 4.5company rating

    Ohio jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The QC Laboratory Specialist is in our Mentor, OH location responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This QC Laboratory Specialist is responsible for performing quality inspection in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to testing raw material, in-process, and finished goods using the various analytical instrumentation (i.e. HPLC, FTIR and/or UV Spectrophotometers) and with supervision to perform failure investigation. This position requires working onsite in our Mentor, OH location. The hours for this role are Monday through Thursday 6:00 am to 3:30pm and Fridays 6:00 am to 10:00 am. What You'll do as a QC Laboratory Specialist Decontaminates, cleans, and sterilizes glassware and other containers. Monitors and maintains laboratory equipment including calibration. Prepares media and reagents. Performs routine product and raw material testing of samples. Performs product and raw material testing of samples. Prepares reagents, standard solutions, equipment for use, etc. Recognizes and communicates unexpected results in a timely manner and completes Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials. Writes and revises standard operating procedures (SOPs) under supervisor's direction, using Quality software to change, submit and review documents. Participates in Investigations (complaints, failure, calibrations, equipment, etc.). The Experience, Skills and Abilities Needed Required: Bachelor's degree in biology, chemistry or related technical field. In lieu of a Bachelor's degree, an Associates' degree in biology, chemistry or related technical field, and a minimum of four years' experience in a laboratory environment is required, preferably in a regulated industry (i.e. FDA / ISO13485). Other: Ability to work in a fast-paced environment with strict deadlines. Make recommendations on improvements to test methods and procedures. Make decisions on experimental steps and data analysis within defined parameters and guidelines. Recognize and communicates unexpected experimental results. Interpret data with direction. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future. Here is just a brief overview of what we offer: Market Competitive pay Extensive Paid Time Off and added Holidays Excellent Healthcare, Dental and Vision benefits Long- and Short-Term Disability coverage 401(k) with a company match Maternity and Paternity Leave Additional add- on benefits / discounts for programs such as Pet Insurance Tuition Reimbursement and continuing education programs Excellent opportunities for advancement in a stable long-term career #LI-MO1 #LI- Onsite Pay range for this opportunity is $43,000 to $55,000. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $43k-55k yearly 53d ago
  • Quality Control Laboratory Specialist -2nd Shift

    Steris 4.5company rating

    Ohio jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The QC Laboratory Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This position is responsible for performing quality inspection in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to testing raw material, in-process, and finished goods using the various analytical instrumentation (i.e. HPLC, GC) and with supervision perform failure investigation. This is a second shift position. Will train Monday - Friday 2:00pm-10:30pm. Will move to Monday - Friday 4:00pm-12:30am when training is complete. What You'll Do as a Quality Control Lab Specialist Decontaminates, cleans, and sterilizes glassware and other containers. Monitors and maintains laboratory equipment including calibration. Prepares media and reagents. Performs routine product and raw material testing of samples. Performs product and raw material testing of samples. Prepares reagents, standard solutions, equipment for use, etc. Recognizes and communicates unexpected results in a timely manner and completes Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials. The Experience, Skills and Abilities Needed Required: Associate degree Minimum four (4) years experience relevant lab testing in a regulated environment (i.e. FDA/ISO 13485). Will accept less years of experience and lab testing in an academic setting with Bachelor degree. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer: • Market Competitive Pay • Extensive Paid Time Off and (9) added Holidays • Excellent Healthcare, Dental and Vision Benefits • Long/Short Term Disability Coverage • 401(k) with a company match • Maternity and Paternity Leave • Additional add-on benefits/discounts for programs such as Pet Insurance • Tuition Reimbursement and continued education programs • Excellent opportunities for advancement in a stable long-term career #LI-KL1 Pay range for this opportunity is $44,412.50 - $54,862.50. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $44.4k-54.9k yearly 42d ago
  • Quality Control Microbiologist

    Tosoh Bioscience 3.9company rating

    Grove City, OH jobs

    Job Details Grove City OH - Grove City, OH Full Time Bachelor's Degree None Standard Business Hours QA - Quality ControlDescription Tosoh Bioscience LLC is a major supplier of chromatography products to the pharmaceutical, biotechnology, and chemical industries. Our product line includes:TSKgel, TOYOPEARL, and Ca++Pure-HA bulk media, TSKgel U/HPLC columns, process development products, dedicated systems for GPC analysis, and the LenS3 MALS detector. We have optimal solutions for biological research, drug discovery, medicinal chemistry, agriculture, manufacturing, or other industrial applications. Summary The Quality Control Microbiologist is responsible for supporting operations of the Tosoh Bioscience LLC quality control laboratories located in Grove City, OH. This position works with the Quality Control and Production teams to ensure compliance with Tosoh Bioscience's quality standards for products used in cGMP manufacturing. The Microbiologist works in collaboration with the Senior Microbiologist as an expert in the assigned area. Technical and/or detailed instruction is provided only upon request when necessitated by a procedural change and/or special project. Reporting Relationships Reports to the Quality Control Manager. This position has no supervisory responsibilities. Major Duties and Responsibilities The Quality Control Microbiologist will perform microbiological examination of finished product within structured regulatory and quality frameworks (e.g. ISO 9001). Perform Environmental Monitoring of manufacturing environment and critical Utilities (water system). Monitoring of surface, air, and nonviable air quality of ISO 7 and 8 cleanrooms. Review and trend environmental monitoring data and publish quarterly and annual trend reports. Perform bioburden and endotoxin testing. Work closely with Manufacturing and Quality Assurance staff to resolve quality issues with regard to the facility. Participate in microbial method validation and special projects related to improvement and validation projects. Perform a variety of microbiologic assays such as culture purity, growth promotion, culture viability, and other tests needed by the Quality Control group Identification of microbial isolates by selective plating and PCR (polymerase chain reaction). Perform general laboratory duties, in house media preparation, and housekeeping. Documentation of data/reports per local procedures and quality requirements. Operate basic software like Microsoft Office and Quality Management Systems. Work independently and with the team effectively to achieve individual, team and organizational goals. Documentation of laboratory work following Good Documentation Practices. Following established safety guidelines to safely work with materials that have biohazard potential. Professional interactions with customers. Maintain regular and reliable attendance. Uphold and adhere to the Tosoh Bioscience culture and guiding principles. Education Bachelor of Science degree in Microbiology, molecular biology, or related field. Skills and Qualifications 1-3 years of lab experience in a cGMP or ISO 9001 environment required with a minimum of 1 year working in a microbiology laboratory, preferably from work in the biopharmaceutical industry or having CMO or CRO experience. Knowledge of Aseptic Techniques and working in clean room environments. Ability to understand, follow, and draft written procedures. Proven ability to conduct experiments according to standard operating procedures. Previous participation in regulatory audits preferred. Extensive knowledge of GMP regulations in cGMP manufacturing environment required. Good oral and written communication skills. Ability to interact effectively with management and prioritize multiple projects. Ability to work in a team environment. Occasional domestic travel may be required. Physical Requirements The physical demands of this job are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Sufficiently medically fit to work in the laboratory to perform assigned duties including the ability to wear personal protection equipment (PPE), lift up to 50 pounds, and work in the proximity of hazardous/infectious materials. Occasional domestic travel may be required. Tosoh Bioscience LLC is an Equal Opportunity Employer M/F/Disabled/Veterans
    $34k-53k yearly est. 15d ago
  • Quality Control Analyst II

    Nitto Denko 4.2company rating

    Cincinnati, OH jobs

    About this opportunity : The QC Analyst II is responsible for executing quality control analytical tasks, including in process manufacturing testing, for one or more projects to support testing and release of oligonucleotides. Key Responsibilities: Sample, test and release raw materials and finished products per established procedures with minimal errors Provide analytical support to Manufacturing and Process Development Perform routine analyses using techniques such as: Wet Chemistry, Karl Fischer, UV-Vis, FT-IR, Raman, LC, GC, LCMS, and NMR Train and/or assist other QC Analysts on applicable analytical techniques Assist in the development and/or qualification of test instructions and protocols Author technical documentation (e.g. methods, procedures) Represent Quality Control on internal project teams Perform GDP peer review Maintain laboratory compliance Execute tasks to deliver project results on time Contribute to a positive work atmosphere Responsibilities may also include water system and environmental monitoring testing Job Experience and Technical Skills: Degree in Chemistry or related field. BA/BS with 2+ years of related work experience. Understand and edit laboratory SOPs Operate laboratory instruments Knowledge of undergraduate general chemistry and organic chemistry Basic Word, Excel, and PowerPoint abilities Perform algebraic and basic statistical calculations correctly Proficient in written and spoken English. Experience with technical writing. The annualized salary for this position is between $63,200.00 - $77,400.00.
    $63.2k-77.4k yearly 3d ago
  • Associate Production Scientist

    Merck 4.6company rating

    Miamisburg, OH jobs

    Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: MilliporeSigma in Miamisburg, OH is hiring an Associate Production Scientist. In this role, you will manufacture or evaluate products according to established protocols, provide technical support to others and perform operations in support of the group and department. Responsibilities: Safely perform operations to meet quality expectations Ensure quality throughout the process Complete the volume of work required to achieve group/departmental goals and meet deadlines Participate as needed in quality audits In compliance with change control procedures, improve processes through application of scientific knowledge, experience, and principles Identify opportunities for process improvement Physical Attributes: Wearing appropriate protective gear, (hard hats, glasses/goggles, chemical resistant suits, gloves, safety shoes) and other personal protection equipment “PPE” to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors or airborne particles Working in outdoor weather conditions while moving material, filling material and waste handling Lifting and/or moving to 50 pounds unassisted and ability to push and pull heavy materials to complete assignment. Lifting more poundage with assistance. Utilize close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus Who You Are: Minimum Qualifications: Bachelor's degree in Chemistry, Biochemistry, Biology or other Science discipline Preferred Qualifications: Bachelor's degree in Chemistry Experience with safe chemical handling methods Excellent communication skills both oral and written Computer skills Mechanical skills Troubleshooting skills Interpersonal skills Organizational skills Knowledge of ISO Quality standards Pay Range for this position: $25.00 - $44.00/hour The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
    $25-44 hourly 60d+ ago
  • Lab Technician II - Pre-Analytics Department

    Cleveland Clinic 4.7company rating

    Akron, OH jobs

    Join us at Cleveland Clinic Akron General Hospital where we have been providing world-class care to our community for over 100 years. Here, we strive for patient-centered care and comfort with our collaborative team of healthcare professionals. We are committed to serving the community and treat our patients as family. Akron General is looking to add a Lab Technician II to the laboratory team who will rotate between three separate assignments: Central Processing, Send Outs, and Outpatient CP. In this role, you will be responsible for processing routine and stat laboratory tests as well as performing specimen investigation procedures to resolve lab specimen issues or problems. This is a very hands-on team and a great place to get your foot in the door. This role can lead to various growth opportunities within the lab. A caregiver in this position works evenings from 12:00PM - 8:30PM or 3:00PM - 11:30PM. A caregiver who excels in this role will: * Receive and accession laboratory specimens into the LIS. * Retrieve, sort, track and deliver specimens. * Accept or reject specimens according to established standards. * Perform specimen investigation procedures to resolve lab specimen issues or problems. * Verify accurate documentation relative to specimen processing. * Maintain patient, specimen and tracking data using the laboratory computer system, tracking software/devices. * Prepare specimens for analysis. * Perform manual processing (centrifuge, aliquoting and routine maintenance). * Perform preventive maintenance, record keeping procedures, basic clerical functions and the placing of work orders. Minimum qualifications for the ideal future caregiver include: * High School Diploma or GED * One year of lab experience OR Associate's degree Preferred qualifications for the ideal future caregiver include: * Associate's Degree in Science * Experience with using computers Physical Requirements: * Ability to perform specimen handling techniques and take measurements. * Ability to perform work in a stationary position for extended periods. * Ability to move throughout the department and hospital system. * Handles and transports biohazardous materials and potential carcinogens. * Ability to differentiate color, hue, saturation, and tones. * Ability to lift/move up to 50 lbs. Personal Protective Equipment: * Follows standard precautions using personal protective equipment as required. Pay Range Minimum hourly: $19.25 Maximum hourly: $29.30 The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic's benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.).
    $19.3-29.3 hourly 8d ago
  • Lab Technician II - Pre-Analytics Department

    Cleveland Clinic 4.7company rating

    Akron, OH jobs

    Join us at Cleveland Clinic Akron General Hospital where we have been providing world-class care to our community for over 100 years. Here, we strive for patient-centered care and comfort with our collaborative team of healthcare professionals. We are committed to serving the community and treat our patients as family. Akron General is looking to add a Lab Technician II to the laboratory team who will rotate between three separate assignments: Central Processing, Send Outs, and Outpatient CP. In this role, you will be responsible for processing routine and stat laboratory tests as well as performing specimen investigation procedures to resolve lab specimen issues or problems. This is a very hands-on team and a great place to get your foot in the door. This role can lead to various growth opportunities within the lab. **A caregiver in this position works evenings from 12:00PM - 8:30PM or 3:00PM - 11:30PM.** A caregiver who excels in this role will: + Receive and accession laboratory specimens into the LIS. + Retrieve, sort, track and deliver specimens. + Accept or reject specimens according to established standards. + Perform specimen investigation procedures to resolve lab specimen issues or problems. + Verify accurate documentation relative to specimen processing. + Maintain patient, specimen and tracking data using the laboratory computer system, tracking software/devices. + Prepare specimens for analysis. + Perform manual processing (centrifuge, aliquoting and routine maintenance). + Perform preventive maintenance, record keeping procedures, basic clerical functions and the placing of work orders. Minimum qualifications for the ideal future caregiver include: + High School Diploma or GED + One year of lab experience OR Associate's degree Preferred qualifications for the ideal future caregiver include: + Associate's Degree in Science + Experience with using computers **Physical Requirements:** + Ability to perform specimen handling techniques and take measurements. + Ability to perform work in a stationary position for extended periods. + Ability to move throughout the department and hospital system. + Handles and transports biohazardous materials and potential carcinogens. + Ability to differentiate color, hue, saturation, and tones. + Ability to lift/move up to 50 lbs. **Personal Protective Equipment:** + Follows standard precautions using personal protective equipment as required. **Pay Range** Minimum hourly: $19.25 Maximum hourly: $29.30 The pay range displayed on this job posting reflects the anticipated range for new hires. A successful candidate's actual compensation will be determined after taking factors into consideration such as the candidate's work history, experience, skill set and education. The pay range displayed does not include any applicable pay practices (e.g., shift differentials, overtime, etc.). The pay range does not include the value of Cleveland Clinic's benefits package (e.g., healthcare, dental and vision benefits, retirement savings account contributions, etc.). Cleveland Clinic Health System is pleased to be an equal employment employer: Women / Minorities / Veterans / Individuals with Disabilities
    $19.3-29.3 hourly 7d ago
  • Quality Control Technician II

    Midmark Corporation 4.5company rating

    Versailles, OH jobs

    Tests and inspects products at various stages of production process and compiles and evaluates statistical data to determine and maintain quality and reliability of products by performing the following duties. Verifies dimensions and clearances of parts to ensure conformance to specification using precision measuring instruments including, but not limited to, calipers, micrometers, hardness testers, profilometers, and electronic voltmeters. Aligns, fits, and assembles component parts, using hand tools, power tools, fixtures, templates. Records test data, applying statistical quality control procedures executing gage R/R (MSA's). Performs setups, programming, and operation of coordinate measuring machines or equivalent machines. Provides training and assistance to staff on coordinate measuring machines (or equivalent). Prepares recommendation modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability. Selects products for tests at specified stages in production process and tests products for a variety of qualities such as dimensions, performances, and mechanical, electrical, or chemical characteristics. Attends and provides input into design reviews with new product development engineering. Evaluates data and writes reports to validate or indicate deviations from existing standards. Prepares graphs or charts of data or enters data into computer for analysis. Performs and/or controls the calibration of test equipment. Performs fixture and tooling validation. Performs in process audits to verify process control. SECONDARY DUTIES: Inspects and releases finished product (finished devices, sub-assemblies, and components) upon ensuring that the acceptance criteria was met. Inspects parts and products returned after distribution to the field. Supports ERP system transactions to support returned goods, incoming inspection, and shipping/receiving. Assists to disposition MRB parts. Sets up quality module for identified measurements per the inspection plans. Maintains a working knowledge of government and industry quality codes and standards. Evaluates device history records. Sets up and performs destructive and nondestructive tests on materials, parts, or products to measure performance, life, or material characteristics. EDUCATION and/or EXPERIENCE: Associate degree or equivalent from two-year college or technical school or 2-5 years of relevant experience and/or training, or equivalent combination of education and experience. ASQ certifications preferred. COMPETENCY and/or SKILL: CMM knowledge preferred Experience with an ERP system Basic math skills and ability to interpret charts and graphs Experience with Microsoft Office Suite Experience with blueprint reading Problem-solving skills Analytical thinking skills Ability to understand and follow directions Ability to work as part of a team Performs work under minimal supervision
    $33k-42k yearly est. Auto-Apply 13d ago

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