QA Operations Associate I

American Regent • New Albany, OH

1d • Onsite

About The Position

This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements.

Requirements

• Basic knowledge of cGMPs and supporting regulatory documents
• 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.
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves.
• 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.
• Employee must be able to occasionally lift and/or move up to 25 pounds.

Nice To Haves

• Associates or Bachelor’s Degree preferred.
• Minimum 1 year work experience in a FDA regulated environment or similarly regulated area is preferred.

Responsibilities

• 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
• 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.

Benefits

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal ( eeoc.gov )
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED