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[QA/QC Manager] QC Manager - Radiopharmaceutical DIRECT HIRE

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We are looking to fill a new full-time, DIRECT HIRE position as a QC Manager. Our client is a face paced, fast growing radiopharmaceutical company and expects significant growth. The QC Manager will support the production of lutetium-177 for the treatment of cancer. This individual the daily responsibilities within the QC laboratory.

The Manager will support the development and drafting method validation documents, executing and drafting final reports, as necessary. Ensuring all QC analytical and microbiological equipment remains in a state of validation and calibration.

This is a newly created position with potential for significant growth. The position will support QC operations at the clinical site and eventually support the transfer of the QC operations at the newly constructed commercial site.

Duties and Responsibilities:
Specific duties and responsibilities include, but are not limited to:
• Ability to develop and draft QC method validation protocols and execute the protocols, as necessary.
• Draft microbiological and analytical method procedures.
• Manage the daily activities within the QC Microbiology and Analytical laboratories.
• Set up Quality Control lab equipment (analytical and microbiological) at the commercial site.
• Manage/Participate in Out of Specification investigations as needed.
• Oversee sampling of raw materials for testing per the material specifications and coordinate testing with contract laboratory.
• Ensure final API product is tested per specifications to allow for release of API.
• Ensure preventative maintenance and calibration activities for analytical and microbiological lab equipment are carried out to schedule.
• Summarize data in support of management review meetings.
• Provide training within the QC department as needed.

Requirements:
• Previous Supervisory experience is preferred.
• Previous work related to radiation type pharmaceuticals is preferred.
• BS in scientific discipline, analytical and microbiological management is preferred.
• Previous experience working in a GMP environment (5-7 years) managing analytical and microbiological laboratories.
• Previous knowledge of HPLC, HPGe and ICP-MS instrumentation
• Willingness to be “hands on”, as necessary, and understand new technology required.
• Ability to write procedures and review documentation required.


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