QA SPECIALIST II - OPS

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