QA Specialist I - Ops

Responsibilities

• Provide QA floor support for manufacturing and visual inspection of medical device products in a GMP facility
• Perform real-time auditing of critical processes, room releases, and GMP documentation review
• Conduct batch record reviews to ensure adherence to internal procedures and Good Documentation Practices
• Review, approve, and disposition incoming materials including consumables and excipients
• Act as a first responder for on-the-floor quality issues and assist in nonconforming material investigations
• Support the initiation of Quality Systems, including deviations, CAPA, and nonconformances
• Participate in root cause analysis (RCA) using methodologies such as fishbone and 5 whys
• Review and approve new and revised GMP documents, SOPs, and product labels
• Guide personnel on cGMP compliance, internal procedures, and regulatory requirements

Requirements

• Knowledge of FDA regulations, specifically 21CFR Part 820
• Exposure to Root Cause Analysis (RCA) and technical writing
• Knowledge and exposure to Risk Management Tools such as FMEA and PHA
• Ability to apply basic scientific principles to solve operational and quality tasks
• Bachelor's Degree in a relevant scientific field preferred, or an equivalent combination of education and experience

Preferred Qualifications

• Minimum of 2 years of experience in a relevant GMP industry
• ASQ certification
• Exposure to lean operational excellence
• Proficiency in MS Office, including Word and Excel
• Strong organizational skills and high attention to detail

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, dedicated to building the bridge between life-changing therapies and patients. We focus on quality and operational excellence, fostering an authentic culture of purposeful work where talented individuals can grow their careers.