Analytical QA Specialist

Job Description:

Reviews raw material and finished products testing result records, including manufacturing C of C or C of A along with laboratory Certificates of Analysis to confirm accuracy makes the determination of acceptability for material/product release.

• Reviews and approves GMP documents such as change control related documents, batch records, method validation protocols and reports, stability protocols and reports, analytical method transfer protocols and reports, validation related documents, etc.
• Makes decisions based on knowledge and interpretation of government regulations and guidelines as well as industry standards, risk based assessments and internal policies to ensure compliance.
• Prioritizes raw material review/release based on production scheduling.
• Review Change Controls, Out of specifications investigations Report, CAPAs, and any other documentation related to Quality Control. Ensure all QMS events are complete and closed prior to release raw material/FP for use.
• Performs ERP transactions to Release/Hold/Reject the raw material and finished products.
• Identifies errors that have potential product impact, assesses compliance risk, decides when to escalate to supervision, and takes action to place lots on Quality Hold or Reject as needed and communicate to the management team.

Need minimum 7-10 years pharmaceutical experience related to material/Product review/release and laboratory functions.

Experience with tools - LIMS , SAP, EMPOWER