Quality Assurance (contract)

Pfizer
Full Time
Remote in Troy Hills, NJ+2 locations
Posted 22 days ago
Job description

Quality Assurance

Location: Hybrid with onsite support in Parsippany. Must be able and comfortable to work from home and be successful working from home.

Summary:

This position will primarily support Scientific Laboratory Services (SLS) Quality Assurance activities at all locations.

Responsibilities:

  • Ensure SLS quality systems are maintained consistent with cGMPs, Pfizer policies, site procedures, and regulatory guidance. The quality systems to be maintained include, but are not limited to, laboratory investigations, instrument/facility qualifications, analytical method validation and transfers, deviation management, notification to management, corrective and preventive actions (CAPAs), site quality review team (SQRT), and change management
  • Ensure testing/administration is conducted in a manner consistent with cGMPs, Pfizer policies, site procedures, and regulatory guidance
  • Review/approve various types of laboratory documentation ensuring that strong scientific justification, adequate impact assessments, and appropriate definition of root cause and corrective actions are identified. These documents would include (but are not limited to) stability study change control, equipment change control, corrective and preventive actions, quality notification reports, testing notes, instrument/facility qualifications, analytical method validation, and transfers and laboratory investigation reports
  • Ensure site quality systems are consistent with cGMPs, Pfizer policies, site procedures, and regulatory guidance
  • Able to interpret quality requirements, both internal and external, and apply them to real-life situations in the pharmaceutical industry
  • Experience with the principles and application of quality risk management
  • Work together with the SLS management to assure that objectives and metrics are met
  • Contribute to quality assurance management team initiatives and objectives
  • Create, track and approve corrective/preventive action items to help ensure they are completed within the agreed timeframes
  • Ensure testing/administration is conducted in a manner consistent with cGMPs, Pfizer policies, site procedures, and regulatory guidance

Qualifications:

  • Bachelor’s degree or higher in Chemistry or related discipline
  • Must have 2+ years of Quality Assurance experience
  • Experience in document review
  • GMP or GLP experience in a Pharma or Medical Device industry
  • Experience with electronic laboratory systems (gQTS, gLIMS, PDOCS) preferred
  • QC/QA experience in a drug product or API manufacturing environment is desirable

Please note contractors are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.

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