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Quality Assurance Manager
2 months ago
We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at ADMA Biomanufacturing LLC. As a key member of our quality assurance department, you will be responsible for ensuring compliance with regulatory requirements and maintaining the highest standards of quality in our manufacturing processes.
Key Responsibilities- Conduct Change Review Board (CRB) meetings to ensure that changes are properly initiated, evaluated, and implemented in accordance with regulatory and corporate requirements.
- Coordinate and perform various quality assurance activities, including the development of new procedures and protocols as assigned by QA management.
- Perform QA review and approval of equipment, process, automation, PD, IT, QC, AD, cleaning, and stability validation protocols and reports.
- Ensure proficiency in cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate policies and procedures.
- Resolve fundamental technical and regulatory issues, as well as resolve and negotiate quality-related issues as needed.
- Utilize Quality Risk Management to identify, assess, control, and review any potential impact to process, product, or equipment.
- Work closely with the Validation team to ensure documentation is accurate and complete.
- Write and perform QA review and approval of additional documentation and quality systems, such as SOPs, forms, reports, deviations, etc., as needed.
- Write and perform QA review and approval of Change Control and Corrective Action Preventive Action (CAPA) Quality Systems.
- Assist with internal, customer, and regulatory audits.
- Assist with new employee and ongoing cGMP and quality-related training as required.
- Bachelor's Degree required in a field related to the title of the position.
- Five to eight years of experience in the pharmaceutical or biotechnology industry.
- Minimum of four years of experience in FDA/CBER regulated industry.
- Competitive compensation package.
- Comprehensive benefits package, including 401K plan with employer match and immediate vesting, medical, vision, life, and dental insurance, pet insurance, company-paid STD and LTD, company-paid holidays, three weeks of paid time off, tuition assistance, and easily accessible transportation options.
