Specialist Product Quality - Biotech (JP4977)
Thousand Oaks, CA
Medical Device Supply & Raw Materials
Initial 13 months with likely extension or conversion to FTE
3Key Consulting Inc. is recruiting for a Specialist Product Quality with experience in GxP manufacturing process and quality systems, for a global CA-based bio-pharmaceutical company.
Manage the development and implementation of clinical and commercial product specifications, in process control documents, and other specification related documents. Facilitation of specification development meetings and the generation of detailed and communicate meeting minutes/action items to all attendees. Other tasks include acting as a change owner and initiator as part of the Change Control Management System (CCMS) to document changes to global documents in a compliant manner. Own nonconformance records (NC), and lead or coordinate activities required to advance NCs to closure. Implement and maintain a product quality data tracking system that facilitates meaningful analysis of release and in process test results (data mining). Additional responsibilities include assisting Product Quality leader function by facilitating team meetings and drafting/distributing meeting minutes, assisting in the management of product sample plans, as well as other assignments and projects as assigned
degree in life science, business or engineering; project management and/or industry experience; experience using computer software such as MS Office (i.e. Excel, Word, Project)
Must Have Skill Sets:
Change Control owner (managing revisions to a specification)
Specification authoring for Single Use Systems (disposable Bags, Filters, Tubing).
Background in GMP manufacturing process
Gathering requirements, generating specifications and managing changes to active specs Supporting advancement of Single use systems in ATO, ASM, and ARI. Start with collecting information to generate raw material specification. Analyzing information to revise the specification. Owning change control record (documenting changes and specifications.) This person will be leading meetings with operations, quality and PD
Employee Value Proposition:
This has the potential to turn into a full-time role. This person would be working on the next new thing in biotech manufacturing with single use systems. Amgen is the leader in this domain. Will gain exposure to leading edge tools in generating specifications. Moving to PLM system (product life cycle management) new to this industry.
Looking for people coming from the technical world and not just knowledge of quality systems. Candidate does not have solid technical background through education or work experience.
30 minute phone interviews to in person interviews.
We invite qualified candidates to send your resume to email@example.com
If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.