QA Operations Associate II

This position is responsible for ensuring overall quality in assigned areas through the execution of site policies, procedures, programs, and work instructions. Ensures all processes and products meet specifications and are produced in accordance with GMP requirements. Requires close collaboration with other departments on production issues, product dispositions, and root-cause investigations for deficiencies.

Responsibilities

• 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 Standard Operating Procedure (SOP) requirements; provide 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.
• Perform chart monitoring and escalate issues 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.
• Provide guidance to plant personnel on documentation and investigations.
• Perform tasks with minimal error rate.
• Perform any other tasks/duties as assigned by management.

Requirements

• 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) preferred.
• Experience in QA working in a cGMP manufacturing environment (preferred).
• 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).
• Proficiency in PC skills (MS Word, Excel).
• Ability to work overtime as needed.

Physical Requirements

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