Quality Control Project Coordinator

Proclinical is currently recruiting for a Quality Control Project Coordinator with a global biopharmaceutical company located in Worcester, MA. Successful candidate will be responsible for overseeing of outsourced analytical GMP activities (CTLs) for late phase clinical and commercial programs from initial feasibility through method qualification, and routine release and stability testing.

Job Responsibilities:

• Technical and program management support of outsourced GMP/GxP release and stability programs.
• Oversight of analytical technology transfer and feasibility, method validation, and routine release and stability testing at CTL vendors.
• Review of release and stability testing data.
• Supports the coordination with Quality and Program Managers to provide project updates, workflows, and timelines.
• Author technical documentation (e.g. SOPs) with appropriate level of guidance, as needed.
• Make presentations on validation and release/stability activities.

Skills and Requirements:

• 3+ years of experience in Quality Control / GMP laboratories is required.
• Experience with vendor management of CTLs is preferred.
• Excellent team skills, organization, and strong.
• Experience working in QC Analytical lab performing method validation, release and stability testing.
• Program Management support.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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