Quality Assurance Specialist

Location: San Diego Consulting
Department: Azzur San Diego, LLC

Job Description

Essential Duties and Responsibilities

The primary responsibility for this role is to review executed batch records and release lots for clinical trials.

Additional responsibilities may include:
Provide oversight for all daily operations within QA, Validation, and documentation groups.
Inventory log and batch record review (contract manufactured product) and disposition of clinical trial material
Track and trend deviations, CAPAs, and out of specification/tolerance reports
Assist with audit prep including planning internal audits and tracking quality action items to closure
Supplier evaluation and oversight
GMP documentation generation, revision, updates, and review
Validation oversight including updating the VMP, managing validation contractors, URS, IQ, OQ, PQ generation and approvals
Ensure site is working within state of cGMP compliance
Maintain training, development, and support for all personnel working within cGMP functions


BS in life sciences or equivalent

5-10 years experience within a pharmaceutical or biotechnology company (or MS with 3-7 years experience)
Strong working knowledge of FDA and cGMP regulations and documentation practices.
Excellent written and verbal communication and technical writing skills.
Proficient in Microsoft Office Suite and able to learn new computer applications.
Demonstrated experience managing others as well as fostering a team focused approach. The ideal candidate shall excel in the areas of communication, leadership, client loyalty, initiative and business integrity.
Must be results oriented with several years of hands-on validation and QA management experience, familiar with industry concepts, practices and procedures in a cGMP environment
Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), and Quality Systems (Change Control, Non-Conformances, Requalification, etc.) is preferred
Must have hands-on experience with batch record review and lot release.

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