QA Specialist, I

QUALIFICATIONS:

• Required:
• 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
• Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 5-7 years of pharmaceutical or biotech industry experience with 3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production
• 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
• Preferred:
• ASQ certification preferred
• #LI-CW1
• Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
• Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
• At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.