QA Operations Materials Associate

American Regent, Inc.•New Albany, OH

About The Position

This position is a member of the Quality Assurance team. 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. This position is responsible for participating in material receipt, then coordinating sampling and inspection for components, in a sterile manufacturing facility. This position is responsible for ensuring the overall Quality of materials as assigned by Quality Management in coordination with other stakeholders such as Materials Management and Operations, etc.

Requirements

High School Diploma or GED equivalent required.
At least two (2) years of related experience (QA, Compliance, Auditing, Laboratory or Inspection, within a GMP environment) preferred.
Must be able to do work independently.
Working knowledge and understanding of quality assurance principles and familiarity with QA programs
Strong analytical skills, attention to detail and adherence to procedures.
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.
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.
Employee must be able to occasionally lift and/or move up to 25 pounds.

Nice To Haves

Associates or Bachelor’s Degree preferred.
Experience in QA working in a cGMP manufacturing environment (preferred)

Responsibilities

Responsible for execution of procedural documentation as they pertain to various aspects of the receiving and sampling processes.
Performs sampling of components.
Conduct verifications and checks through accurate material inspections.
Identify out of specification materials ensuring segregation and escalation, and perform any activities required within the Trackwise Events system
Management of BPCS for verification and disposition of materials
Maintain retain samples for all primary and secondary components and labeling
Performance of DAF (Destruction Approval) process for rejected materials
Use of Trackwise and Veeva for change controls, as needed
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.
Ensure all components and raw materials are appropriately prepared for the applicable status disposition, including all relevant documentation.
Support generation of logbooks and sheets/labels as required.
Basic knowledge of cGMPs and supporting regulatory documents
Perform room, area and equipment clearances that may be necessary for this job function.
Able to perform tasks with minimal error rate.
Assist other Quality Assurance Operations Associates, as needed.
Perform any other tasks/duties as assigned by management.