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Snr QA Specialist

Wayne Metro Area, New Jersey

Post Date: 05/10/2017 Job ID: JN -052017-19038 Industry: Quality Assurance - Scientific
Snr QA Specialist - Biologics
The individual in this role will be responsible for providing Quality Assurance (QA) support to Manufacturing, Quality Control, Analytical Development and Process Development. The individual will primarily work with Manufacturing Associates, Quality Control Analysts, and other QA Specialists in supporting clinical product manufacturing and testing. The successful candidate must have experience in a biotech or pharmaceutical cGMP environment.

Responsibilities
Write and review GMP documentation (SOPs, protocols, technical reports, specifications, etc.)
Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met
Review validation protocols and reports to ensure compliance
Review protocols, analytical results, and documents associated with investigations, OOS results, etc., and corrective/preventive action plans
Support disposition of raw materials, drug substance, and drug product
Review stability protocols and reports
Collaborate with Manufacturing to resolve equipment and process issues

KNOWLEDGE/SKILLS/ABILITIES (KSA s):

Minimum Qualifications
Minimum education required: BS in a scientific or engineering discipline
Minimum experience required: 3 - 5 years Quality Assurance experience in the pharmaceutical/biotech industry

Preferred Qualifications
Knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical/biotech products
Knowledge of cGMP principles with respect to US, EU, and other relevant regulatory guidance
Experience in reviewing and approving cGMP related documents (SOPs, protocols, reports, batch records, etc.)
Proficiency with enterprise systems, i.e., documentation, LMS (learning management systems), deviations, CAPA, etc.
Experience in participating in deviation investigations, determining root cause, and developing corrective action plans
Ability to identify technical problems and suggest resolution of the issues
Experience with cellular therapeutics

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