Quality Systems Manager

Pharma Industry Update: A Manufacturing QMS Specialist position is available in South Plainfield, NJ.

Position Overview:

The Manufacturing QMS Specialist will play a critical role in ensuring smooth and compliant manufacturing operations by managing essential documentation processes. The position requires hands-on expertise in both Upstream (USP) and Downstream (DSP) biologics manufacturing processes, including cytokine and monoclonal antibody production.

Key Responsibilities:

• Act as the main support for the manufacturing team regarding all documentation needs.
• Review and manage executed batch records for upstream and downstream processes.
• File and oversee change controls, deviations, and CAPAs for the manufacturing department.
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We at Global Life Science Hub are recruiting on behalf of an innovative biotech company based in New Jersey that is experiencing rapid growth after securing two FDA approvals and advancing a strong pipeline of assets. As the company moves from R&D to commercial-scale operations, they are significantly expanding their manufacturing and quality management capabilities, with plans to double their workforce within two years.

We are seeking a Quality Management System (QMS) Associate to join their team in New Jersey. In this role, you will support the implementation and maintenance of quality systems in compliance with GMP regulations, playing a vital part in ensuring product integrity and regulatory adherence throughout the manufacturing process.

Key Responsibilities:

• Support the development and execution of QMS procedures and processes to uphold GMP compliance.
• Assist in the review and management of quality...

We have an opening for a Quality Systems Manager on 1st shift working out of our Port Washington, WI location.

The Quality Systems Manager will direct and maintain all daily operations of the Quality Assurance/Quality Control department at our Port Washington location and have some responsibilities at our Mequon and Milwaukee locations . They will ensure that the sites comply with all Regulatory, Customer, and Kleen Test Products requirements as they relate to quality systems and quality of the product.

What can KTP do for you?

• Develop yourself - Opportunities for rapid growth and advancement.
• Stability - We've never had a lay off!
• Respect and teamwork - You are not just a number at KTP; join our team and let us prove it to you!
  

Essential Functions

• Ensure compliance to Regulatory, Customer, and Kleen Test Products quality systems requirements.
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