QA Operations Associate - Hilliard, OH

Nature and Scope

This position is responsible for ensuring overall quality in assigned areas through the execution of site policies and procedures, programs and work instructions. All processes and products must meet specifications and be produced in accordance with GMP requirements.

• Achieve and maintain packaging line and inspection room clearance qualification
• Conduct accurate verifications and checks as well as accurate process inspections
• Conduct accurate packaging AQL inspections
• Identify out of specification product, ensuring segregation and escalation, as required
• Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements
• Ensure all work is performed and documented in accordance with existing company policies and procedures, as well as 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 logbooks and sheets/labels
• Review Bills of Materials
• 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
• Able to perform tasks with minimal error rate
• Perform any other tasks/duties as assigned by management

ATTENTION MILITARY AFFILIATED JOB SEEKERS – Our organization works with partner companies to source qualified talent for their open roles. This position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers.

High School/GED

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

• Employee must be able to occasionally lift and/or move up to 25 pounds.
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and respirators are essential for the health and safety of employees.
• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
• Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.

City:
Hilliard
State:
Ohio

American Regent