QA Operations Associate I

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.

Responsibilities

• Achieve and maintain packaging line and inspection room clearance qualification
• Conduct accurate verifications, checks, and process inspections
• Perform accurate packaging AQL inspections
• Identify out-of-specification product, ensuring segregation and escalation as required
• Resolve errors and omissions according to Standard Operating Procedure (SOP) requirements
• Ensure all work is performed and documented in accordance with Company policies, cGMP, and health and safety requirements
• Conduct component and raw material release
• Perform chart monitoring and escalation as required
• Support product shipping activities and perform quality-related oversight and verifications
• Generate logbooks, sheets, and labels
• Review Bills of Materials
• Maintain basic knowledge of cGMPs and supporting regulatory documents
• Achieve and maintain clean side gown and sterile side gown qualifications
• Achieve and maintain Class A qualification
• Perform room, area, and equipment clearances
• Participate in Media Fill and maintain qualification
• Perform tasks with minimal error rate
• Perform any other tasks or duties as assigned by management

Requirements

• High School Diploma or GED equivalent required; Associate’s or Bachelor’s Degree preferred
• Minimum 1 year of work experience in an FDA-regulated environment or similarly regulated area is preferred
• Ability to work independently
• Intermediate skills in Microsoft Word and Excel
• Excellent organizational, interpersonal, and communication skills (written and oral)
• Ability to take feedback constructively and function in a team-oriented work environment
• Ability to work overtime as needed

Physical Environment and Requirements

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