Quality Control, Environmental Monitoring Specialist

Piper Companies is currently seeking a Quality Control, Environmental Monitoring Specialist for an opportunity in Chapel Hill, North Carolina. The Quality Control, Environmental Monitoring Specialist will get to join an elite team whose focus is on CART T-cell therapy, and will also get the chance to see their work from product to patient. This unique opportunity will allow for an individual to create a environmental monitoring program and lay the ground work needed for the proper functioning of the facility.

Responsibilities of the Quality Control, Environmental Monitoring Specialist:

• Work with third party vendors to assist in the development of an Environmental Monitoring program
• Develop a baseline study to understand the functioning of the facility
• Work cross-functionally with Quality Control specialist to ensure cleanroom are qualified within the required timeframe.
• Oversee and establish gowning qualifications.
• Investigate any EM excursions and develop CAPAs to improve EM results
• Trend EM results as needed
• Train staff on proper aseptic techniques

Qualifications of the Quality Control, Environmental Monitoring Specialist:

• 3 years of experience in a GMP environment
• Experience with Environmental Monitoring Testing in support of manufacturing processes
• Bachelor's in Biology, Chemistry, or Related Discipline

Compensation for the Quality Control, Environmental Monitoring Specialist:

• Salary Range: $75,000, flexible depending on years of experience
• Comprehensive Benefits: Medical, Dental, Vision, 401k

Keywords: Quality Control, QC, Environmental Monitoring, EM, SOP's, inspection, manufacturing, investigate, material inspection, air sampling, endotoxin, bioburden, CART-t cell therapy, GMP

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