QA Operations Associate III

Overview

Nature and Scope:
This position is responsible for ensuring the overall quality in the assigned areas through the execution of site policies and procedures, programs, and work instructions. It ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. The role requires working closely with other departments on production issues, product dispositions, and investigations into root causes for deficiencies.

• Achieve and maintain equipment and room clearance qualification.
• Conduct accurate verifications and checks during in‑process inspections.
• Identify out‑of‑specification product, ensuring segregation and escalation as required.
• Resolve errors and omissions according to SOP requirements, providing guidance to plant personnel on document corrections and investigations.
• Ensure all work is performed and documented in accordance with company policies, cGMP, health and safety requirements.
• Conduct component and raw material release.
• Conduct chart monitoring, ensuring escalation as required.
• Support product shipping activities and perform quality‑related oversight and verifications.
• Generate controlled documents such as logbooks and labels.
• Review Bills of Materials.
• Achieve and maintain clean‑side gown and sterile‑side gown qualifications.
• Participate in Media Fill and maintain qualification.
• Partner with other departments to implement timely procedural changes and resolve compliance issues.
• Conduct investigations and continuous quality improvement initiatives (e.g., CAPAs) with minimal supervision.
• Generate reports that describe these activities.
• Implement regulatory documents and apply them to non‑routine issues.
• Mentor other QA Operations associates.
• Provide guidance to plant personnel on documentation and investigations.
• Perform tasks with minimal error rate.
• Perform any other tasks or duties as assigned by management.

• High School Diploma or GED equivalent required.
• Associate’s or Bachelor’s Degree preferred.
• At least two (2) years of related experience (QA, compliance, auditing, laboratory, or inspection) within a GMP environment required.
• Experience in QA working in a cGMP manufacturing environment required.
• Working knowledge and understanding of quality assurance principles and familiarity with QA programs.
• Strong analytical skills, attention to detail, and adherence to procedures.
• Demonstrated ability to work effectively under dynamic constraints.
• Strong organizational, interpersonal, and communication skills (oral and written).
• PC skills required (MS Word, Excel).
• Ability to work overtime as needed.
• Basic knowledge and application of cGMPs and supporting regulatory documents.

• Physically able to wear cleanroom/protective gowning and equipment, including gowning, goggles, face shields, respirators, and protective gloves.
• PPE and respirators essential for health and safety.
• Specific vision requirements: 20/20 near vision (corrected with eyeglasses or contacts) and color vision.
• Employees must maintain a clean‑shaven appearance each shift to wear tight‑fitting respirators properly.
• Must be able to occasionally lift and/or move up to 25 pounds.

American Regent celebrates diversity and is committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws.