The Senior QA Specialist performs a wide variety of Quality Assurance activities to ensure compliance with regulatory requirements. Writes, revises, approves and processes cGMP documents such as: Standard Operation Procedures, Forms, and Batch Records. May conduct investigations related to manufactured products and resolves and negotiates issues as needed. Ensures regulatory compliance as defined in government regulations CFR 210, 211, and 600. Writes, processes, and reviews SOPs, Investigational Reports and other controlled documents. Approves QA Quality System documents such as Deviations, CAPAs, Change Controls, and OOSs. Reviews all QA system documents and makes suggestions for improvement. Initiates reviews or approves QA system related documents. Trains other department members in related QA activity. Conducts QA related meetings in support of QA systems such as EDMS, CRB and NCMR. Assists management in direction of QA I and II in their job responsibilities.
A Bachelor’s Degree preferred but can be offset by work experience. A minimum of five to eight years’ experience in pharmaceutical or biotechnology industry. Minimum of four years’ experience in FDA/CBER regulated industry. Previous knowledge of scientific, medical and regulatory terms. Ability to use personal computer and software including word processing, spreadsheet and database. Excellent organizational skills with close attention to detail and accuracy. Good verbal communication skills to effectively train personnel. Excellent problem solving skills with minimal supervision. Mathematical skills including the use of calculations involving fractions, decimals and percentages. Proficient in cGMP.