We are PCI, a company that specializes in biopharma services. We are seeking a QA Specialist II - Operations to work with other departments to ensure the quality of products and compliance to internal procedures and external standards. The successful candidate will have a Bachelor's Degree in a relevant scientific discipline and at least 5-7 years of experience in the pharmaceutical or biotech industry. The role involves reviewing batch documentation, performing quality oversight, and ensuring compliance with regulations.
Requirements
- Bachelor's Degree in a relevant scientific discipline
- At least 5-7 years of experience in the pharmaceutical or biotech industry
- 3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
- Experience performing RCA, technical writing, and working with quality related investigations
- Knowledge of laboratory and production equipment and IQ/OQ/PQ
- Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH
- Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9
- ASQ certification preferred
- Exceptional organizational skills and attention to detail
- Ability to make risk based decisions and resolve issues with minimal guidance
- Excellent interpersonal skills and the ability to communicate well orally and in writing
- Proficiency in MS Office including Word, Excel, Access and Visio
- Excellent verbal and written communication skills required
- Ability to work in a dynamic, fast paced work environment
- Honesty, integrity, respect and courtesy with all colleagues
- Creative with the ability to work with minimal supervision and balanced with independent thinking
- Resilient through operational and organizational change
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Relocation Assistance