Senior Quality Assurance Specialist
4 days ago
ADMA Biologics is a biopharmaceutical company committed to creating superior products for immunodeficient patients at risk for infection. We are seeking a Senior Quality Assurance Specialist to perform a wide variety of Quality Assurance activities to ensure compliance with regulatory requirements.
The ideal candidate will have a strong background in quality assurance, with a focus on regulatory compliance and cGMP. They will be responsible for the efficacy and compliance of the change control management system, validation and qualification systems, Corrective Action and Preventive Action (CAPA) reports and risk management policies and procedures.
Responsibilities will include conducting Change Review Board (CRB) to ensure that changes are initiated, evaluated, properly classified, authorized and implemented in accordance with Regulatory and Corporate requirements. They will also coordinate and perform any additional activities or projects including the development of new procedures as assigned by QA management.
The successful candidate will be proficient 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. They will also be able to resolve fundamental technical and regulatory issues, as well as resolve and negotiate quality related issues, as needed.
Additionally, they will utilize Quality Risk Management to identify, assess, control and review any potential impact to process, product or equipment. They will suggest and initiate quality improvement plans, work closely with the Validation team and provide support to ensure documentation is accurate and complete.
Requirements include a Bachelor's Degree in a field related to the title of the position and five to eight years of experience in the pharmaceutical or biotechnology industry. Minimum of four years of experience in FDA/CBER regulated industry is required.
We offer a 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 paid time off and tuition assistance.
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