Quality assurance manager jobs in Wake Forest, NC

Immediate need for a talented UAT Test Lead/Manager. This is a 12 months contract opportunity with long-term potential and is located in NC - Raleigh (Hybrid). Please review the job description below and contact me ASAP if you are interested. Job ID: 25-93419 Pay Range: $55 - $61.25/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: We are seeking an experienced UAT Test Lead to manage and execute User Acceptance Testing for a critical Credit Risk project. This role will serve as the primary liaison between business stakeholders and technical teams, ensuring that all testing activities align with business objectives and regulatory requirements. The UAT Test Lead will be responsible for developing test plans, creating and reviewing test cases, managing onshore and offshore testing teams, and driving defect triage and resolution. Strong communication and leadership skills are essential to coordinate across multiple teams and deliver high-quality outcomes within project timelines. Key Requirements and Technology Experience: Key Skills; UAT Product Testing regulatory testing The ideal candidate will have deep expertise in UAT processes and a solid understanding of the Credit Risk domain. Experience in managing distributed teams and collaborating with both business and technical stakeholders is critical. Proficiency in Agile tools such as Rally for tracking user stories, test cases, and defects is required. Candidates should demonstrate strong problem-solving abilities, attention to detail, and familiarity with compliance and regulatory testing standards. Excellent communication and stakeholder management skills are a must to ensure successful delivery in a fast-paced environment. Financial Services Industry Experience. Product Testing Experience. Technology Project Experience. Our client is a leading Banking Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

The Quality Engineering Project Manager, based in Wilson, NC, will evaluate, design, and build a dedicated workspace within Kneat for method verification and transfer execution worksheets, protocols, and reports. The position focuses on developing a strategic roadmap, creating system-aligned templates, and integrating electronic documentation and data workflows. Prior hands-on experience in method transfer and verification, foundational programming knowledge, and proficiency in digital systems like Excel are advantageous to support compliant, structured data management. Responsibilities: Train on and establish an account in Kneat. Evaluate optimal application of the Kneat system for quality management processes. Construct the needed infrastructure in the workspace and roadmap execution. Create and align templates for electronic documentation and data workflows. Experience: 8-10 years of relevant work experience. Advanced Kneat experience. Proficiency in Microsoft Word, Excel, and PowerPoint. Strong soft skills to foster change and adaptability. Ability to work with software in regulated environments (GMP) Experience writing method validation or transfer protocols in MS Word. Experience supporting digital systems for compliant data management. Available to work full-time (40 hrs/week) on-site in Wilson, NC, with reliable transportation. Foundational understanding of programming. Skills: Quality Assurance & Kenat Experience Education: Bachelors About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit ************************ US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Recruiter Details: Name: Azhar Email: **************************** Internal Id: 25-53776

AirClean Systems Job Title : QA Manager Department or Division : Quality Reports To : CTO Written By : Kendall Ashe JOB TASKS, DUTIES, AND RESPONSIBILITIES The QA Manager is responsible for helping to execute and improve the Quality Management System to AirClean Systems' requirements. The QA Manager heavily participates in the company's production activities, ensuring the in-process QC and final QC is done correctly on all equipment manufactured. The QA Manager also runs the non-conforming material reports (NCMR) program including analysis of trends and determination of the need for corrective and preventive actions (CAPA). All calibrated equipment and calibration records go through the Quality department to ensure accuracy and availability. The QA Manager also signs off on Engineering Change Orders (ECO) to ensure accuracy and any updates to products have the correct quality control checks in place. In addition, the QA Manager collaborates with the different departments to ensure the company maintains its quality system. JOB DUTIES: Helps execute and improve the Quality Management System. Daily audits of in-process QC and final QC checks to ensure product quality. Trains production and QC employees on proper techniques. Keeps the calibration records on file and reviews/approves third party calibrations performed. Helps ensure Engineering Change Orders actually capture changes and quality control checks are updated accordingly. Reviews non-conforming material reports created by the company, investigates, determines root cause, implements corrections and corrective actions, verifies effectives, and ensures timely closures. Starts CAPAs when needed and brings them through the entire CAPA process as well. Creates, audits, and revises current QC and build procedures and work instructions. Ensures that only repaired units passing final acceptance testing leave the company for customer use. Performs other quality duties as required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. MINIMUM QUALIFICATIONS A four-year engineering degree. Excellent written and oral communication skills. Strong Documentation skills. Must have experience writing procedures and work instructions. Ability to be both hands on and to lead. Strong analytical and problem-solving skills, including solid understanding of electromechanical troubleshooting 5+ years of broad quality system/regulated environment experience. PREFERRED QUALIFICATIONS ASQ Certification or other quality certifications are desirable. ISO 9001 quality system experience Accountabilities High quality products are produced by the factory. In-process and QC and final QC is executed thoroughly and correctly. Timely execution and closure of CAPAs and NCMRs. Calibrated Equipment is calibrated on-time, on a schedule, and available to production, service, and quality when needed. Robust QC procedures and training on QC processes. Communication and relationship with other departments is one of mutual respect and cooperation. The Quality Management System is improved over time. LOCATION This position will be based at our Creedmoor, NC office. Terms of employment This is a full-time, salaried, exempt position. HOURS The general hours shall be Monday - Friday, 8:00am to 5:00pm with an hour break for lunch. Work Environment Work is regularly performed in office and warehouse environments. 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. The employee is frequently required to sit. The employee is occasionally required to stand and/or walk. The employee must occasionally lift, carry, push or pull up to 40 pounds. Travell Minimal travel may be required. BENEFITS Compensation package includes health insurance, dental insurance, vision insurance, short term disability, life insurance and Teladoc following an introductory period. The Company offers a 401K plan with employer contribution. The Company also offers paid time off and paid holidays. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. The purpose of this position is to provide oversight and drive / maintain harmonization of technical programs that govern implementation and execution of Sterility Assurance control strategies across the Lilly Parenteral Network. This position also influences peers within Lilly globally and at the site level, as well as external to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs. This role also aids and enables building technical capability at Lilly sites to ensure the vital capabilities are developed and in place to meet business objectives. Finally, this role provides ad-hoc technical support to Lilly PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. Responsibilities: * Assess differences in current sterility assurance programs across the sites and drive harmonization * Work closely with site and multi-functional SMEs to drive cohesion. Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Ensure control strategies are robust, consistent with regulatory and compliance expectations, and are continuously improved. * Assume SME leadership role for a specific topic area within Sterility Assurance across the network, including harmonization of aspects of the topic area and facilitation of the knowledge across the network. * Represent TS/MS on network Science Lead Team and other appropriate governance forums. Ensure that Sterility Assurance programs and similar topics are frequently presented to network team in order to align across sites. Ensure that learnings and best practices are shared across sites: set-up appropriate forums in order to achieve this and present case studies to site SMEs. * Provide mentoring leadership to site SMEs to help build continue to build capability, particularly at the newer sites or where deep technical expertise is lacking. * Building, maintaining, and growing capability across the organization in the sterility assurance space * Provide technical support to new sites/ filling lines during design and start-up activities to ensure sterility assurance programs and process/ product requirements are supported at these sites, particularly while the sites are in early stages of building capability. * Provide technical support for significant sterility assurance investigations to help identify root cause and implement appropriate corrective actions. Share best practices / learnings / CAPAs across the other sites. * Benchmark industry trends and emerging regulatory guidance / requirements in the field through building an extensive peer network and attendance at relevant industry and regulatory meetings and advocacy groups. Advance Lilly agenda in the field. Represent Lilly on relevant external bodies related to Sterility Assurance; be influential in terms of representing Lilly's position on technical/ regulatory positions papers and guidance. Assess new technologies to ensure Lilly stays current with new trends and technologies and share with the network with the goal of staying current with industry best practice. * Work with PR&D on new technology / platform development and implementation for pipeline products. Influence the agenda within PR&D to ensure the needs of Manufacturing are met, and the control strategies are fit for-purpose for robust and compliant commercial manufacturing. * Provide ad-hoc technical support to Lilly organizations outside of the PPN including PR&D, external contract manufacturing, and non-sterile drug substance (API) manufacturing. * Engage in providing support during regulatory interactions such as RtQ of submissions, and on-site inspections * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals Basic Qualifications: * BS Degree required. * MS/PhD in a biological science preferred. * 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles preferred. * 10+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment preferred. * Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation) * Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities * Strong written and oral communication skills * Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Demonstrated experience influencing site and network leaders to advance technical agenda projects Additional Preferences: * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance * Experience in leading external committees or conferences to ensure Lilly remains a leader in the sterility assurance space * Work with engineering SME's to support Lilly platforms to maximize the performance and minimize the risk of sterility assurance * Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options. * Strong capability to influence personnel and management across the organization * Close interaction with quality to enable internal audits that identify risks * Past experience in creating effective working relationships with all levels across internal and external stakeholders impacting the success of sterility assurance. Additional Information: * Approximately 25% travel Lilly currently anticipates that the base salary for this position could range from between $133,500 to $220,000 and will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $133,500 - $246,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Working at Freudenberg: We will wow your world! Responsibilities: Maintain & Elevate the QMS: Drive continuous improvement and ensure compliance with ISO 9001 and other industry certifications. Own the Audit Process: Plan and execute internal audits, facilitate third-party and customer audits, and lead corrective actions with precision. Run the Quality Lab: Oversee daily lab operations, including product testing, inspections, and equipment calibration. Partner with Leadership: Report on QMS performance and improvement opportunities to senior management, influencing strategic decisions. Keep Customers at the Heart: Promote customer requirements across the organization to ensure every product meets expectations Qualifications: Bachelor's degree in a relevant technical field (e.g., Engineering, Science) or equivalent experience 5+ years experience in a quality leadership or management role Proven experience implementing and maintaining an ISO 9001 compliant QMS Experience managing quality control in a manufacturing environment or testing laboratory The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law. Freudenberg Performance Materials LP (USA)

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Essential Functions * Independently conduct audits * Review and oversee results of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits * Facilitate Sponsor health authority inspections of global clinical facilities and study sites * Continuously drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs * Direct skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies. * May be responsible for direct people management including goal setting, performance management, development, and engagement. Requirements * Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. * 5+ years of experience in GCP auditing. * Substantial experience in inspection management. * Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials. * Demonstrated ability to operate and influence decision-making processes * Effective communication skills * Successful track record of supervising employees and managing cross-cultural differences * Technical and administrative capabilities to independently carry out routine, complex and for-cause audits * Knowledge of data integrity controls and systems quality for clinical area * Strong analytical skills and report writing skills * Experience with GxP systems including computer system validation and associated regulations, recommended. * Ability to Travel (approximately 20%) * Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities. Eisai Salary Transparency Language: The base salary range for the Director, Clinical Quality Assurance is from :195,000-256,000 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit *********************************************** Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information: Right To Work E-Verify Participation

Director, QA Drug Substance Operations Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations. In this role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that all released batches are manufactured and tested in strict compliance with Good Manufacturing Practices (GMP) regulations. You will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play a crucial part in fostering a strong Quality Culture within the Quality function and amongst supporting teams. As a member of the site Quality leadership team, you will contribute to the cohesive implementation of quality systems across the Holly Springs, NC site, ensuring alignment with organizational goals and regulatory requirements. Join us and take your career to the next level in our dynamic and innovative environment. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: *************************************************** Job Description What You'll Do Develops strategic plans for QA team operations, sets measurable goals, and oversees the supervision, development, and performance of personnel to foster a high-performing team environment Leads and manages the QA DSM Operations teams, including the Batch Review and Release teams and the Quality Engineering/Validation team, ensuring alignment with organizational goals and regulatory requirements Ensures effective resource allocation and capacity planning to meet operational demands while maintaining compliance with quality standards Provides comprehensive QA oversight and support for manufacturing operations and associated support functions such as Process Science, Engineering Science, Process Engineering, Validation, and Automation Ensures the quality assurance (QA) review and approval of exceptions and CAPAs, while also facilitating the timely review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols and reports, risk assessments, changeover processes, equipment release, and sample plans. Additionally, approves drug substance (DS) retain requests as necessary Establishes robust QA processes to ensure adherence to cGMP regulations and alignment with client Quality Agreements Assesses the impact of system and process modifications, ensuring effective oversight of change management processes to maintain validated states of manufacturing systems throughout their lifecycle Ensures Quality batch Disposition and collaborates with partners, external stakeholders and other parts in the Quality function, as needed Oversees validation activities during startup and commercial operations to ensure compliance with regulatory standards Approves critical lifecycle documentation, including risk assessments, product/process/equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports Ensures documentation is accurate, complete, and compliant with regulatory expectations to support operational readiness Drives a robust Quality Culture across the site by fostering collaboration within the operational peer network and embedding quality principles into daily activities Acts as a key advocate for quality excellence across all levels of the organization Generates, reviews, and approves QA documentation, procedures, and processes to support operational readiness objectives in a CGMP-regulated facility Oversees the preparation of trend reports for process performance and environmental monitoring to ensure continuous improvement. Collaborates with other FUJIFILM Diosynth Biotechnologies sites to harmonize processes, share best practices, and maximize efficiency across the network Actively participates in cross-functional initiatives to align global quality strategies Partners with internal stakeholders and clients to define functional specifications and process together with monitoring of Quality metrics for GMP Operations Works with internal teams and clients to manage data used for continuous manufacturing, validation activities, continuous improvement initiatives, and regulatory commitments Drives the team's efforts in curating critical knowledge and developing best practices in Quality and Operations disciplines Serves as a key stakeholder in business development efforts while defining the future large-scale operations model, including contributing to the site's digital roadmap for GxP process data management Mentors employees and oversees their development to ensure the team is positioned for long-term growth and success Partners with HR, Talent Acquisition, and other stakeholders to attract top talent while developing effective retention strategies Evaluates team performance regularly, implements measures to improve productivity and engagement levels, and identifies high-potential employees for further development opportunities Performs other duties, as assigned Minimum Requirements: • Bachelor's degree in engineering, life sciences with 13+ years of related experience OR • Master's degree in engineering, life sciences with 11+ years of related experience OR • Ph.D. in engineering, life sciences with 9+ years of related experience • 10+ years of people management, leadership, and team management experience • Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility. • Experience and working knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines. • Experience collaborating and interacting with a global team. • Training and/or familiarity with Quality Risk Management principles Preferred Requirements: • 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility • Experience in other GMP functions (manufacturing, MSAT, Engineering) • Strong track record of driving operational excellence • Experience with the following processes such as,TrackWise, Veeva, SAP, Syncade Physical and Work Environment Requirements: Ability to discern audible cues. Ability to stand for prolonged periods of time up to 120 minutes Ability to sit for prolonged periods of time up to 120 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

Director, QA Drug Substance Operations Are you a strategic leader with expertise in managing teams of QA professionals and collaborating seamlessly with manufacturing and support functions? If you are motivated and possess strong operational excellence skills, we have an exceptional opportunity for you to lead and grow in a world-class Quality organization as the Director, QA Drug Substance Operations. In this role, you will oversee our Quality Product and Validation teams, along with the batch review and release teams. Your responsibilities will include ensuring that all released batches are manufactured and tested in strict compliance with Good Manufacturing Practices (GMP) regulations. You will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will play a crucial part in fostering a strong Quality Culture within the Quality function and amongst supporting teams. As a member of the site Quality leadership team, you will contribute to the cohesive implementation of quality systems across the Holly Springs, NC site, ensuring alignment with organizational goals and regulatory requirements. Join us and take your career to the next level in our dynamic and innovative environment. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: *************************************************** Job Description What You'll Do * Develops strategic plans for QA team operations, sets measurable goals, and oversees the supervision, development, and performance of personnel to foster a high-performing team environment * Leads and manages the QA DSM Operations teams, including the Batch Review and Release teams and the Quality Engineering/Validation team, ensuring alignment with organizational goals and regulatory requirements * Ensures effective resource allocation and capacity planning to meet operational demands while maintaining compliance with quality standards * Provides comprehensive QA oversight and support for manufacturing operations and associated support functions such as Process Science, Engineering Science, Process Engineering, Validation, and Automation * Ensures the quality assurance (QA) review and approval of exceptions and CAPAs, while also facilitating the timely review and approval of process performance qualification (PPQ) protocols and reports, continuous process monitoring protocols and reports, risk assessments, changeover processes, equipment release, and sample plans. Additionally, approves drug substance (DS) retain requests as necessary * Establishes robust QA processes to ensure adherence to cGMP regulations and alignment with client Quality Agreements * Assesses the impact of system and process modifications, ensuring effective oversight of change management processes to maintain validated states of manufacturing systems throughout their lifecycle * Ensures Quality batch Disposition and collaborates with partners, external stakeholders and other parts in the Quality function, as needed * Oversees validation activities during startup and commercial operations to ensure compliance with regulatory standards * Approves critical lifecycle documentation, including risk assessments, product/process/equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports * Ensures documentation is accurate, complete, and compliant with regulatory expectations to support operational readiness * Drives a robust Quality Culture across the site by fostering collaboration within the operational peer network and embedding quality principles into daily activities * Acts as a key advocate for quality excellence across all levels of the organization * Generates, reviews, and approves QA documentation, procedures, and processes to support operational readiness objectives in a CGMP-regulated facility * Oversees the preparation of trend reports for process performance and environmental monitoring to ensure continuous improvement. * Collaborates with other FUJIFILM Diosynth Biotechnologies sites to harmonize processes, share best practices, and maximize efficiency across the network * Actively participates in cross-functional initiatives to align global quality strategies * Partners with internal stakeholders and clients to define functional specifications and process together with monitoring of Quality metrics for GMP Operations * Works with internal teams and clients to manage data used for continuous manufacturing, validation activities, continuous improvement initiatives, and regulatory commitments * Drives the team's efforts in curating critical knowledge and developing best practices in Quality and Operations disciplines * Serves as a key stakeholder in business development efforts while defining the future large-scale operations model, including contributing to the site's digital roadmap for GxP process data management * Mentors employees and oversees their development to ensure the team is positioned for long-term growth and success * Partners with HR, Talent Acquisition, and other stakeholders to attract top talent while developing effective retention strategies * Evaluates team performance regularly, implements measures to improve productivity and engagement levels, and identifies high-potential employees for further development opportunities * Performs other duties, as assigned Minimum Requirements: * Bachelor's degree in engineering, life sciences with 13+ years of related experience OR• Master's degree in engineering, life sciences with 11+ years of related experience OR• Ph.D. in engineering, life sciences with 9+ years of related experience• 10+ years of people management, leadership, and team management experience• Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility.• Experience and working knowledge of ICHQ7 and 21CFR part 820 and part 11 and EU GMP vol 4 including ALCOA+ guidelines.• Experience collaborating and interacting with a global team. * Training and/or familiarity with Quality Risk Management principles Preferred Requirements: * 10+ years' experience in a GMP quality assurance (QA) role in commercial biopharmaceutical facility • Experience in other GMP functions (manufacturing, MSAT, Engineering)• Strong track record of driving operational excellence• Experience with the following processes such as,TrackWise, Veeva, SAP, Syncade Physical and Work Environment Requirements: Ability to discern audible cues. Ability to stand for prolonged periods of time up to 120 minutes Ability to sit for prolonged periods of time up to 120 minutes Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. Ability to conduct work that includes moving objects up to 10 pounds. To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid. EEO Information Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. ADA Information If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_****************).

Why Us? At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day. Summary The Quality Control (QC) Manager serves as a Quality Control technical resource to the plant. She/he is the primary point of contact for the testing of all raw materials, in-process, finished goods, and stability samples. She/he manages the Quality Control group and compliance activities to achieve key site and corporate objectives. The Quality Control Manager is responsible for overseeing all QC activities to ensure pharmaceutical products meet regulatory requirements and internal quality standards. This role involves managing QC laboratories, supervising testing processes, and ensuring compliance with Good Manufacturing Practices (GMP) and applicable regulations (FDA, EMA, ICH). This individual will provide overall QC leadership regarding cGMP compliance concerns and improvements, as well as manage budget line items, overtime, efficiency improvements, and staffing. Job Description ESSENTIAL FUNCTIONS: Develop and implement QC policies, SOPs, and testing protocols in compliance with GMP and regulatory guidelines. Oversee analysis of raw materials, in-process samples, and finished products to ensure they meet specifications. Ensure adherence to FDA, EMA, and other regulatory standards, including PIC/S GMP requirements. Maintain accurate records of all QC activities, including test results, deviations, and corrective actions. Manage and train QC staff, assign tasks, and monitor performance to maintain high standards of quality. Identify quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA). Prepare for and participate in internal and external audits, including regulatory inspections. Oversee calibration, validation, and maintenance of laboratory instruments. Provides subject matter assistance for LIMS, methods, testing, and validation. Manages QC testing group to achieve compliant testing in a timely manner. Manages Lab investigations and OOSs including remediation of potential compliance concerns. Provides overall leadership to QC group regarding cGMP compliance improvement and enhancement. Studies and improves various Quality processes providing increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation. Drives Quality consistency through reviewing/revising various analytical methods/SOPs to ensure adequacy with special emphasis on actual utility of methods under normal QC conditions. Works with plant Managers/Supervisors and Quality technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations. Acts as a liaison between the lab and manufacturing/ R&D for investigations and to implement special projects, assist with validations, method transfers, or technology upgrades. Works with groups to ensure compliance to EHS and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in the laboratory. Ensures key turnaround timelines for customer service and compliance requirements are achieved. Performs as a subject matter expert during customer and regulatory audits. Work closely with Production, R&D, and Quality Assurance teams to ensure product quality throughout the lifecycle. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS: Develops and coaches to build talent. Participate in a 5S Workplace System to ensure good housekeeping and organization. Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy. Effectively trains others in a positive manner. Other duties as assigned with or without accommodation. MINIMUM REQUIREMENTS: Education: B.S. /B.A. in Physical Science required. Master's Degree preferred. Experience: 10 - 12 years related experience preferred; at least five years of experience in a supervisory role; strong knowledge of current pharmaceutical cGMP requirements Preferred Skills/Qualifications: Other Skills/Competencies: Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories Experience with testing API or Pharma products Experience leading a group of up to 20 people with 24/7 shift operations Excellent written and verbal communication and leadership skills Ability to work in and promote a team environment Working knowledge of Six Sigma and/or Lean manufacturing tools Sense of urgency. Action oriented/drives for results Excellent communication and interpersonal skills Team orientation/strong team player Ability to coach, mentor and teach Excellent decision making, problem solving and analytical skills Strong managerial courage Ability to influence change at all levels of the organization Detail-oriented with the ability to work under tight deadlines Excellent conflict management skills Builds positive relationships with others Excellent time management and prioritization skills Excellent technical writing skills LIMS experience preferred Knows the difference between managing and leading and when to apply each Command Skills, Action Oriented, Conflict Management, Customer Focus, Problem Solving, Priority Setting, Written Communication, RELATIONSHIP WITH OTHERS/ SCOPE: Reports to Site Quality Director Work is performed without appreciable direction Develops strategic objectives for group managed Exercises considerable latitude in determining technical objectives of assignment Completed work is reviewed for desired results from a relatively long-term perspective Bias toward change, management of change, and achievement of results Contact with FDA as subject matter expert during site inspections and customers during frequent customer audits Regular contacts include Quality Assurance, Materials Management, Logistics, Commercial, R&D, Site Production Leaders and EH&S. This position has several direct reports WORKING CONDITIONS: 60% normal office and meeting room conditions. 40% Laboratory and Plant environment including exposure to raw materials and finished products. Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines. Some off shift and weekend work can be expected; travel requirements are minimal DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Job Description Job Title Job Reports To (Manager's Title) Quality Control Manager Program Manager Department Job Grade Compensation Operations Status Post date Close date ☐ Exempt ☒ Non-Exempt ☒ Full-Time ☐ Part-Time 10/22/2025 Position Summary: The Quality Control Manager (QCM) will serve as the primary authority for ensuring contract performance objectives, standards, and deliverables are met across all 81st Readiness Division (RD) sites. This position is contingent upon contract award and plays a critical role in maintaining mission readiness, service consistency, and compliance with the contract's Quality Assurance Surveillance Plan (QASP) requirements. The QCM will design, implement, and manage a standardized Quality Control Program that supports all operational areas including Base Operations, Real Property, and Environmental services. Through proactive monitoring, detailed reporting, and root-cause analysis, the QCM will ensure the highest level of quality and customer satisfaction. This position is contingent upon contract award and is for a possible contract. Duties and Responsibilities: Serve as the primary quality authority with full responsibility and accountability for contract compliance, performance standards, and deliverable verification. Direct and maintain a standardized Quality Control (QC) Program across all sites under the 81st RD's area of responsibility. Develop, implement, and continually improve a Quality Control Plan (QCP) consistent with contract requirements and aligned with the government's Quality Assurance Surveillance Plan (QASP) § Employ continuous inspection processes and data-driven trend analysis using mobile Contractor Support System (CSS) checklists and digital dashboards. Conduct quality audits, performance evaluations, and preventive-action reviews to identify systemic issues and implement effective corrective measures. Ensure that inspection findings and trend data are communicated promptly to the Program Manager and government representatives. Facilitate regular QC meetings to evaluate performance results, discuss process improvements, and validate corrective action outcomes. Develop and maintain enterprise-wide quality metrics and performance documentation for reporting to the COR/Stakeholders Collaborate closely with the Program Manager (PM) and Site Safety and Health Officer (SSHO) while maintaining independent oversight per contract requirements. Foster a culture of quality excellence through training, awareness, and accountability across all contract sites. Required Qualifications: The Contractor shall provide a QCM who has full authority and responsibility for assuring performance objectives and standards identified in this contract are met. The QCM must have a minimum of 3 years of satisfactory and relevant experience at a comparable level of responsibility in projects of similar size, scope, and complexity. Must pass a background screen Preferred Qualifications: ISO 9001:2015 Lead Auditor certification (preferred). Bachelor's degree in Quality Assurance, Engineering, Business Administration, or a related technical discipline. Demonstrated experience managing quality programs in DoD, USACE, environments. Strong understanding of FAR 52.246-1 Quality Assurance, inspection protocols, and federal QC documentation standards. Proven ability to employ data-driven methodologies for identifying performance trends and implementing preventive actions. Excellent analytical, communication, and leadership skills, with the ability to drive cross-functional quality initiatives. Proficiency with Contractor Support Systems (CSS), SharePoint, and Microsoft Power BI for QC reporting and analysis. Pay: Negotiable Location: 81st Readiness Division Charlotte, NC Concord, NC Cary, NC Garner, NC McLeansville, NC Winterville, NC High Point, NC Lumberton, NC Morehead City, NC Rocky Mount, NC Salisbury, NC Wilson, NC Winston-Salem, NC Wilmington, NC Knightdale, NC Florence, SC Myrtle Beach, SC Physical and Technical Environment: Prolonged periods of sitting at a desk and working on a computer. · Must be able to lift to 40 pounds at a time. · Must be able to travel to offsite assignments. Benefits: 401(k) Dental insurance Health insurance Life insurance Vision insurance Vacation Time Sick Time (The right is reserved under provisions PL 93-638 Section (b), (f), (g), (i), 20 USD450 Indian Self Determination and Education Assistance Act of 1974 to give PREFERENCE AND OPPORTUNITY for employment, training, and contracts to Indians)

Job Title: QC Laboratory Manager Business Introduction: We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. Position Summary: Are you ready to lead a team that ensures the highest quality standards in laboratory operations? As a QC Laboratory Manager, you will oversee laboratory activities to ensure compliance with regulatory requirements and good manufacturing practices. You will play a key role in developing your team, driving continuous improvement, and collaborating across departments to deliver impactful results. This role offers growth opportunities, meaningful contributions, and alignment with GSK's mission to unite science, technology, and talent to get ahead of disease together. Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Develop and implement strategies to ensure laboratory compliance with regulatory standards and company policies. Lead and mentor a team of laboratory professionals, fostering their growth and development. Manage laboratory operations, including resource allocation, budgets, and equipment maintenance. Oversee audits and inspections, ensuring adherence to safety and quality standards. Drive continuous improvement initiatives to enhance efficiency, quality, and cost-effectiveness. Collaborate with cross-functional teams to support production and new product introductions. Basic Qualifications: We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Bachelor's degree in a scientific field such as chemistry, biochemistry, or related discipline. 5+ years of experience in a GMP-regulated laboratory environment. 5+ years of experience supervising or managing a team. Experience with laboratory audits and inspections. Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's degree in a scientific field. Strong leadership and interpersonal skills. Experience in analytical method validation and transfer processes. Ability to prioritize and manage multiple tasks effectively. Excellent verbal and written communication skills. Familiarity with continuous improvement methodologies and tools. Proven experience in a quality support role within the pharmaceutical or biopharmaceutical industry. Strong knowledge of laboratory compliance and regulatory requirements. #LI-GSK This role is on-site and based in the United States. If you are passionate about quality, leadership, and making a difference, we encourage you to apply today! Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at ************************ where you can also request a call. Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at *********************************

Job Title: QC Laboratory Manager Business Introduction: We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. Position Summary: Are you ready to lead a team that ensures the highest quality standards in laboratory operations? As a QC Laboratory Manager, you will oversee laboratory activities to ensure compliance with regulatory requirements and good manufacturing practices. You will play a key role in developing your team, driving continuous improvement, and collaborating across departments to deliver impactful results. This role offers growth opportunities, meaningful contributions, and alignment with GSK's mission to unite science, technology, and talent to get ahead of disease together. Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Develop and implement strategies to ensure laboratory compliance with regulatory standards and company policies. Lead and mentor a team of laboratory professionals, fostering their growth and development. Manage laboratory operations, including resource allocation, budgets, and equipment maintenance. Oversee audits and inspections, ensuring adherence to safety and quality standards. Drive continuous improvement initiatives to enhance efficiency, quality, and cost-effectiveness. Collaborate with cross-functional teams to support production and new product introductions. Basic Qualifications: We are seeking professionals with the following required skills and qualifications to help us achieve our goals: Bachelor's degree in a scientific field such as chemistry, biochemistry, or related discipline. 5+ years of experience in a GMP-regulated laboratory environment. 5+ years of experience supervising or managing a team. Experience with laboratory audits and inspections. Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's degree in a scientific field. Strong leadership and interpersonal skills. Experience in analytical method validation and transfer processes. Ability to prioritize and manage multiple tasks effectively. Excellent verbal and written communication skills. Familiarity with continuous improvement methodologies and tools. Proven experience in a quality support role within the pharmaceutical or biopharmaceutical industry. Strong knowledge of laboratory compliance and regulatory requirements. #LI-GSK This role is on-site and based in the United States. If you are passionate about quality, leadership, and making a difference, we encourage you to apply today! Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at ************************ where you can also request a call. Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at *********************************

Site Name: USA - North Carolina - Zebulon Job Title: QC Laboratory Manager Business Introduction: We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients. Position Summary: Are you ready to lead a team that ensures the highest quality standards in laboratory operations? As a QC Laboratory Manager, you will oversee laboratory activities to ensure compliance with regulatory requirements and good manufacturing practices. You will play a key role in developing your team, driving continuous improvement, and collaborating across departments to deliver impactful results. This role offers growth opportunities, meaningful contributions, and alignment with GSK's mission to unite science, technology, and talent to get ahead of disease together. Responsibilities: This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: * Develop and implement strategies to ensure laboratory compliance with regulatory standards and company policies. * Lead and mentor a team of laboratory professionals, fostering their growth and development. * Manage laboratory operations, including resource allocation, budgets, and equipment maintenance. * Oversee audits and inspections, ensuring adherence to safety and quality standards. * Drive continuous improvement initiatives to enhance efficiency, quality, and cost-effectiveness. * Collaborate with cross-functional teams to support production and new product introductions. Basic Qualifications: We are seeking professionals with the following required skills and qualifications to help us achieve our goals: * Bachelor's degree in a scientific field such as chemistry, biochemistry, or related discipline. * 5+ years of experience in a GMP-regulated laboratory environment. * 5+ years of experience supervising or managing a team. * Experience with laboratory audits and inspections. Preferred Qualifications: If you have the following characteristics, it would be a plus: * Master's degree in a scientific field. * Strong leadership and interpersonal skills. * Experience in analytical method validation and transfer processes. * Ability to prioritize and manage multiple tasks effectively. * Excellent verbal and written communication skills. * Familiarity with continuous improvement methodologies and tools. * Proven experience in a quality support role within the pharmaceutical or biopharmaceutical industry. * Strong knowledge of laboratory compliance and regulatory requirements. #LI-GSK This role is on-site and based in the United States. If you are passionate about quality, leadership, and making a difference, we encourage you to apply today! Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at ************************ where you can also request a call. Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at *********************************

About Kriya Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. We are proud to have been named Triangle Business Journal's Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America's Best Startup Employers of 2024,” and honored as one of BioSpace's “2025 Best Places to Work.” Role Overview The Manager of the Quality Control Technical Services' group is responsible for stability, sample management, third-party laboratory management, incoming material sampling/inspections, and LIMS support. They are expected to design and manage the GMP systems within their area of responsibility while building a high-performing team that drives cross-functional success. This leader mentors and develops direct reports, promotes accountability and innovation, and manages day-to-day activities with an emphasis on strategic coordination and technical excellence. Key Responsibilities Responsible for managing the GMP stability program across multiple programs with the support of direct reports. The stability program responsibilities include designing the stability studies, managing the pulls, tracking stability testing, issuing time point CoAs, trending data, and authoring the final stability reports. Overseeing the process for the aliquoting and distribution of manufacturing, stability, and incoming material samples. Maintain third-party testing laboratory relationships and ensuring proper GMP oversite. Ensure samples are shipped and subsequent data is being reviewed in a timely manner. Manage the process for the QC inspection of incoming materials, including sampling, and submission of samples for testing. Manage the employee(s) responsible for LIMS master data creation and approval. Develop any procedures and supporting training materials for their areas of responsibility. Support/address investigations occurring within their areas of responsibility. Ensure continuous compliance with applicable cGMP regulations and SOPs, and support regulatory audits. Ensure direct reports receive the proper support, coaching, and career development necessary to thrive within their position and at Kriya. Experience & Skills BS degree in Chemistry, Microbiology, Biological Sciences, or related field Advanced degree preferred 6+ years of relevant experience Previous experience supervising/managing people or large projects is strongly preferred An equivalent combination of education and experience is acceptable Experience in designing, trending, and reviewing stability studies. Highly organized and demonstrated ability to manage critical activities with strict requirements. Strong knowledge of cGMP, SOPs, change controls, deviations, and other quality control processes Excellent and effective written, verbal communication and presentation skills Work Environment Primarily in an office or laboratory setting May involve standing, sitting, and using laboratory equipment for extended periods. Discover True Collaborative Teamwork We have an ambitious set of goals, but our confidence - and our inspiration - stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day. We're always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us. Rewards & Benefits Medical, Dental and Vision ∙ 401(k) with Company Match ∙ Short and Long-term Disability Benefits ∙ Company Paid Holidays ∙ Flexible Time Off ∙ Cyber Safety protection ∙ EAP ∙ Life Insurance ∙ Equity ∙ and more! Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All job requirements in the provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.

The Quality Control Manager is responsible for planning, coordinating and developing the project specific Quality Assurance/Quality Control plan that incorporates policies and procedures necessary to deliver the project fully compliant with the contract terms of the project. Responsibilities Partner with the project team to understand, plan, and implement the contract drawings and specifications Collaborate with the owner, design team, and contractors to ensure quality and timeliness of project construction and completion Implement and manage the "Three Phases of Control" Quality Control Plan Schedule and conduct quality control meetings - Preparatory, Initial Phase, Follow-up Control documents related to quality control functions Establish testing procedures in accordance with contract specifications Manage inspections process Coordinate third party testing agents and interface with the Owner's representatives as required Closely track and maintain a project deficiency log Manage the punch list process Oversee project closeout deliverable process-training, O&Ms Confer directly with the executive management team Encourage, lead, and/or participate in staff training and development Basic Qualifications Undergraduate degree in a construction or related discipline or relevant experience Minimum 5-8+ years verifiable construction quality control and/or inspection experience Takes initiative and personal responsibility to always deliver value and excellence Uses expertise to create a vision and aligns the team to deliver/achieve desired outcomes A track record of establishing/contributing to creative strategic solutions Ability to communicate effectively with, persuade, and gain "buy-in" from, a broad range of stakeholders (leadership team, Business Unit Leader, direct reports, clients, trade partners, and third party providers) Alignment to BE&K standards, self-motivated, results oriented, adaptable, team player, accountable, ethical, innovative, resilient, builds relationships, builds people/teams and followership, sets direction and executes Preferred Qualifications Experience in large scale Bio-Pharma construction projects Prior experience developing and managing Quality Control Plans Physical Requirements: Ability to perform physical activities such as climbing, lifting, balancing, walking, and handling materials. Must be able to work in various weather conditions, including extreme heat and cold. Capable of standing and walking for extended periods. Ability to lift and carry up to 50 pounds. Equal Employment Opportunity Statement: BE&K Building Group is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. Beam is preparing to open a state-of-the-art Manufacturing facility located on Davis Drive in RTP, NC and will be looking for Manufacturing and Quality professionals to join our team! Please submit your resume here to be considered for positions that we will be opening in Q4 2022 and throughout 2023. We are looking for fearless innovators who are passionate about helping patients and looking to join a collaborative environment where you will be able to have a direct impact on getting our facility up and running.

**Country:** United States of America ** Onsite **U.S. Citizen, U.S. Person, or Immigration Status Requirements:** This job requires a U.S. Person. A U.S. Person is a lawful permanent resident as defined in 8 U.S.C. 1101(a)(20) or who is a protected individual as defined by 8 U.S.C. 1324b(a)(3). U.S. citizens, U.S. nationals, U.S. permanent residents, or individuals granted refugee or asylee status in the U.S. are considered U.S. persons. For a complete definition of "U.S. Person" go here. ********************************************************************************************** **Security Clearance:** None/Not Required The Fire Protection business unit at Collins Aerospace is seeking a Customer Quality Program Manager (CQM). The CQM acts as the primary customer point of contact for quality and is focused on improving customer satisfaction through quality improvement initiatives. The CQM serves as the customer's voice throughout the organization, working alongside program management to lead a cross functional team in the resolution of known issues and drive preventative actions to reduce quality escapes. This position is in a multi-disciplinary team environment and will require one who thrives on tackling challenges. The position relies on the use of problem-solving skills in a hands-on work environment to address problems and implement appropriate solutions. A successful candidate will have some technical knowledge of manufacturing processes and experience with requirements compliance. Familiarity with purchase/sales order logistics is also desired. Heavy customer interaction will be required in this role to develop and maintain a collaborative rapport. **What You Will Do:** + Accountable for root cause corrective action investigations for nonconformance escapes with a cross functional team including members from product quality, manufacturing engineering, design engineering, operations, etc. + Performs escape management procedures for disclosure of nonconforming hardware + Leads customer audits/assessments as required + Manages customer satisfaction metrics and develops plans to recover and maintain goals + Review customer quality requirements to ensure compliance with requirements, objectives, and/or contracts + Identifies and manages risk in product development primarily utilizing and driving PPAP core elements (e.g. PFMEA, MSA, Process Flow and Control Plans, etc.) **Qualifications You Must Have:** + Typically requires a degree in Science, Technology, Engineering or Mathematics (STEM) and minimum 8 years prior relevant experience **or** an Advanced Degree in a related field + In-depth knowledge of Quality Management System(s) and Root Cause Analysis tools. + Experienced and comfortable with customer-facing responsibilities **Qualifications You Must Have:** + 5+ years in Aerospace with solid knowledge of Quality Assurance in production / manufacturing and new product development. + FAA, EASA and other regulatory authority knowledge with PMR / MRB, Corrective action methodology experience is desired. + Certified in the appropriate ASQ Body of Knowledge (CQE, CQA, CRE, CPA) **What We Offer:** _Some of our competitive benefits package includes: _ + Medical, dental, and vision insurance + Three weeks of vacation for newly hired employees + Generous 401(k) plan that includes employer matching funds and separate employer retirement contribution, including a Lifetime Income Strategy option + Tuition reimbursement program + Student Loan Repayment Program + Life insurance and disability coverage + Optional coverages you can buy pet insurance, home and auto insurance, additional life and accident insurance, critical illness insurance, group legal, ID theft protection + Birth, adoption, parental leave benefits + Ovia Health, fertility, and family planning + Adoption Assistance + Autism Benefit + Employee Assistance Plan, including up to 10 free counseling sessions + Healthy You Incentives, wellness rewards program + Doctor on Demand, virtual doctor visits + Bright Horizons, child and elder care services + Teladoc Medical Experts, second opinion program + This position may be eligible for relocation + And more! **Learn More and Apply Now!** Collins Aerospace, a RTX company, is a leader in technologically advanced and intelligent solutions for the global aerospace and defense industry. Collins Aerospace has the capabilities, comprehensive portfolio and expertise to solve customers' toughest challenges and to meet the demands of a rapidly evolving global market. Our **Avionics** team advances flight deck solutions, airborne communications, vision systems, sensors and fire protection for commercial and military customers around the world. That means we're helping people reach their destination safely and keeping pilots, passengers, flight crews, airlines, airports and military personnel connected and informed. And we're providing industry-leading fire protection and safety systems that our customers can count on when it matters most. Are you ready to learn from the most knowledgeable experts in the industry, develop the technologies of tomorrow and reach new heights in your career? Join our Avionics team today. **WE ARE REDEFINING AEROSPACE.** * Please consider the following role type definitions as you apply for this role. **Onsite:** Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance employees, as they are essential to the development of our products. _Regardless of your role type, collaboration and innovation are critical to our business and all employees will have access to digital tools so they can work with colleagues around the world - and access to Collins sites when their work requires in-person meetings._ At Collins, the paths we pave together lead to limitless possibility. And the bonds we form - with our customers and with each other -- propel us all higher, again and again. Apply now and be part of the team that's redefining aerospace, every day. **_As part of our commitment to maintaining a secure hiring process, candidates may be asked to attend select steps of the interview process in-person at one of our office locations, regardless of whether the role is designated as on-site, hybrid or remote._** The salary range for this role is 101,000 USD - 203,000 USD. The salary range provided is a good faith estimate representative of all experience levels. RTX considers several factors when extending an offer, including but not limited to, the role, function and associated responsibilities, a candidate's work experience, location, education/training, and key skills. Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement. Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company's performance. This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply. RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. _RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans' Readjustment Assistance Act._ **Privacy Policy and Terms:** Click on this link (******************************************************** to read the Policy and Terms Raytheon Technologies is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, age or any other federally protected class.

Job Description Responsible for supervision of the day-to-day operations of the performance improvement and risk management functions of the organization. He/she will assure that accurate and complete data is used to assess quality of services delivered, collaborate with leadership and clinicians to strategize, and monitor quality improvement modalities, and identify opportunities for minimizing risk in the delivery of services. Assist the organization in fulfilling its mission of providing high quality compassionate health care and implementing a culture of quality at all levels of the organization. RESPONSIBILITIES AND DUTIES To provide leadership and advice in the implementation of the organizational Quality Improvement/Quality Assurance Plan; To work with medical staff as well as accounting and medical coders to achieve maximum accuracy and completeness of coding for medical services provided; To assist the Chief Medical Officer in direction and implementation of the activities of the Quality and Safety Committee; To compile assessment of areas of maximum risk within the organization at least quarterly and recommend strategies for minimizing risk of adverse events; To communicate effectively with staff at all levels in initiatives involving quality improvement or minimization of risk; Serve as a local subject matter expert on electronic health record (EHR) and ancillary data infrastructure. Monitor clinical workflows and recommend process improvements to optimize clinical service delivery and related data capture; Provide timely consultation and training to both providers and staff that enhance the quality of care being provided and the accuracy of data being captured in the clinical documentation, coding and billing processes; Provides orientation to new staff members in the areas of Performance Improvement, OSHA, and Clinical Policies and Procedures; Accreditation: Recommend improvements to programs, policies and/or workflows to ensure PCMH status is maintained and advanced into the future; Quality: Partner with the Chief Medical Officer to regularly monitor all facets of FCCHC's board-approved Quality Improvement / Quality Assurance Plan, including those specific clinical initiatives mandated by the Health Resources and Services Administration (HRSA), Center for Medicare and Medicaid Services (CMS) and contracted managed care organizations (MCO's). Ensure that FCCHC providers are well informed of quality measures and well equipped to succeed in future value-based payment initiatives; Participates in other related activities affecting the clinic programs (e.g., grant application requirements, patient data analysis, committees, recruitment and orientation); Complete the Uniform Data System and Federal Tort Claims Act on an annual basis based upon required due dates; Produce regular reports regarding quality indicators and other chart audit data. Preparations for Quality Assurance staff meetings by developing agendas, taking minutes and compiling and distributing packets to include preparation of the CMO's Report to the Board of Directors; Audit charts on the use of various screening tools and as requested by the Chief Medical Officer; Risk: Oversee a portfolio of initiatives that collectively minimize FCCHC's liability and malpractice risk exposure. Coordinate, schedule and/or deliver timely trainings on identified risk topics. Consult with Chief Financial Officer and insurance broker to leverage external training and resources that minimize risk. Serve as key member of FCCHC's Quality and Safety Committee. Chairs committee in the absence of the Chief Medical Officer; and Performs other necessary duties as required by the CMO to meet the goals of providing primary health care services. QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE: Bachelor's degree in a clinical specialty as a minimum, advance degree preferred. Minimum 3-5 years of experience in clinical quality and risk management activities. LANGUAGE SKILLS: Ability to read and comprehend written materials. Ability to write clearly and concisely. Ability to communicate effectively one-on-one or for small groups. Ability to make formal presentations to groups. Ability to communicate with patients and family members of various educational, socio-economic, and cultural backgrounds. MATHEMATICAL SKILLS: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rates, ratios and percents. REASONING ABILITY: Ability to solve practical problems and utilize appropriate steps for problem resolution. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to exercise sound judgment. COMPETENCY/SKILLS REQUIREMENTS: Competency required in the areas of interpersonal communications, excellent verbal and written skills, and knowledgeable of Medicare and regulatory and credentialing criteria and standards. Knowledge of safety standards, spread of organisms, and the adult learning process. CPR certified. OTHER SKILLS AND ABILITIES: Ability to operate all basic office machines and equipment. Ability to assess and visually present data using run charts, flow charts, scatter diagrams, control charts, histograms, decision matrices, etc. Ability to deal effectively with stress and to work under pressure. Ability to exercise flexibility in work schedule. Basic word processing and general computer skills. Computer skills to include proficiency with the use of Microsoft word, excel, publisher, PrintShop. PHYSICAL/MENTAL DEMANDS: The physical/mental 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 disability to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear, sit, and use hands to finger, handle, or feel objects, tools, or controls. The employee is occasionally required to stand, walk, climb, balance on two feet, stoop, kneel, crouch, or reach with hands and arms. The employee must occasionally lift and/or move patients of varying weight. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Mental demands include the ability to learn and adapt to changes, exercise discretion and good judgment, develop options and solutions to crisis and problems, gather and analyze facts, pay close attention to detail, courteous and professional, deal with stressful situations such as emergencies and/or staff shortages, and to adhere to company policies and procedures. WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate. Powered by JazzHR HpJvIMU3Kh

Immediate need for a talented Project Manager 2 - Quality Engineering/Quality Management Platform Analyst. This is a 12 Months Contract opportunity with long-term potential and is located in Wilson, NC(Onsite). Please review the job description below and contact me ASAP if you are interested. Job Diva ID: 25-94614 Pay Range: $51 - $53/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location). Key Responsibilities: Train on and establish an account in Kneat, Evaluate how to optimally apply the system, Construct the needed infrastructure in our workspace and roadmap the execution Available to work full-time (40 hrs./week) with reliable transportation to and from work Must be available to work Monday through Friday 8AM to 5PM Must be able to work in the US and must not require sponsorship for employment visa status now or in the future (e.g., FI, H1-B status). Key Requirements and Technology Experience: Key Skills; Experience using Kneat, MS word and in writing method validation or transfer protocols BS Experience and Skills: Required: Incumbent must be proficient with Word, Excel, Power Point, have the soft skills needed to nurture change, as well as, the acuity to use software nuanced to operate in a regulated environment. Generally Requires 8-10 Years Work Experience Kneat experience required A Major in Bio-Medical Engineering, Chemistry or Biology Other Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration. Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. By applying to our jobs, you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.