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QARM Specifications Coordinator

Harmans, MD

Posted: 12/10/2020 Industry: Manufacturing Technician Job Number: JN -122020-12274

Job Description

QA Raw Materials Specifications Coordinator

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: QA Raw Materials Specifications Coordinator
  • Location: Harmans, MD
  • Industry: Pharmaceutical
  • Hours: Mon-Fri 8AM - 5PM
  • Salary: $27.41hr (Paid Weekly - Benefits Available)
  • Employment Type: 12 month Contract
Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply and optimal performance of our products.

Job Scope:

The QA, Raw Materials Team is responsible for ensuring the quality of incoming materials and components meet quality expectations needed to assure patient safety. This begins with assuring the material requirements are formalized as specifications for receiving materials intended for GMP manufacturing.

Knowledge/Skills Requirements:
Create raw material specifications according to template requirements and information provided by technical groups.
Route Specifications for review and approval through workflow in Master control. Review edits and revise Raw Material specifications as indicated.
Edit raw materials specifications as needed for client requests or supplier change notifications
Create change controls and represent QA-RM team at Change Control review board as needed
Engage with technical teams and Supply Chain as necessary to proactively collect documentation for pending specifications.
Adjust the materials specification templates as needed to assure compliance with regulations and client expectations.

SKILLS & TECHNICAL EXPERTISE:
Experience with Good Manufacturing Practices (GMPs) a plus
Experience using MasterControl and ability to create workflows and reports from these systems
Expert in formatting in Microsoft Word and use of edit tools.
Good communication skills and ability to work in a group setting where priorities may be shifted weekly
Ability to work in a cross functional team and escalate concerns related to priorities and patient first concepts

Experience:
B.S. in a Life Sciences discipline
Hands on experience with Master Control creating documents for a GMP environment, a plus.
Experience with Good Manufacturing Practices (GMPs) and 21 CFR part 11, a plus

EOE/ADA


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