Our client is a leader in the biopharmaceutical industry. They are in need of a QA Compliance Specialist for their R&D program.
- Assists in developing, implementing and maintaining a specialized quality system to support the R&D programs including quality assurance for GMP and GLP supplies.
- Oversee and coordinates investigations, provides direction and guidance for investigations and executes them when needed.
- Provide Quality Systems support for complex technical projects and in troubleshooting activities.
- Assist with Contract Development and Manufacturing (CDMO) and product technical transfers to commercial state.
- Assist in building, maintaining and continuously improving a specialized quality system to support R&D and CDMO programs.
- Ensure Good Manufacturing Practices (cGMP) compliance in such areas as batch production and record review and retention.
- Answers customer communications and helps build a customer support program.
- Reviews completed batch records for completeness, accuracy and compliance to process parameters.
- Actively participates as quality support to R&D and the manufacturing departments that is performing the technical transfer.
- Completes Deviations and Corrective Action / Preventive Action (CAPAs) as needed.
- Perform internal audits
- Serve as right hand person to Quality Manager
- Bachelor's Degree in Chemistry or related field.
- 4+ years of similar experience in the pharmaceutical / biopharmaceutical / medical device industry (FDA regulated industry).
- Experience with GMP, GLP, cGMP, and SOPs.
- Strong investigation handling through all stages including deviations and CAPAs
The company offers a comprehensive benefits package including:
- Very competitive salary based upon experience
- Health, dental, life and disability insurance
- Bonus program
- 401K with match
- Paid vacation and holidays
- Tuition reimbursement
Jump start your career and apply now! We review all resumes and applications submitted. A staff member will contact you directly if you meet the qualifications for the position. No visa sponsorship or relocation assistance is available.
Associated topics: performance test, prevent, qa, quality, quality assurance engineer, quality assurance lead, software quality, software quality assurance, test engineer, tester