QA Operations Associate I

American Regent, Inc.•Hilliard, OH

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. Essential duties and Responsibilities Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. We all must embrace the QUALITY culture.

Requirements

High School Diploma or GED equivalent required.
Minimum 1 year work experience in a 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.

Nice To Haves

Associates or Bachelor’s Degree 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
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.