QA SPECIALIST II - OPS

As a QA Specialist II - Operations at PCI Pharma Services, you will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. Primary responsibilities include batch record review, lot disposition, and quality system review.

Requirements

• Bachelor's Degree in a relevant scientific discipline
• 5-7 years of pharmaceutical or biotech industry experience
• 3+ years of experience in a QA Operations role
• 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 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
• 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

• Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
• PCI is an equal opportunity employer and committed to cultivating an inclusive workplace.
• Less than 10% travel required.