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Piper Life Sciences has an opening available for a Quality Control Analytical Specialist I with a rapidly growing pharmaceutical company in Frederick, MD. This role works with various departments to ensure quality standards of cell therapy products are being fully achieved.

Responsibilities for the QC Analytical Specialist I include:

• Testing, monitoring, and verifying method performance, product quality, reagent usage, and/or stability data by using ELISA, qPCR, cell bioassays, and flow cytometry
• Maintaining, calibrating, and operating ELISA, qPCR, ddPCR, cell bioassays, and flow cytometry equipment and instruments
• Assisting with CAPAs, deviations, investigations, and change control activities
• Tracking the lifecycle of logbooks and review processes
• Review and revise Standard Operating Procedures (SOPs), protocols, and technical reports
• Supporting transfer and validation activities for analytical methods for Clinical to Commercial QC, and Commercial QC to external testing locations and sites
• Assisting in preparation for site visits and inspections

Qualifications for the QC Analytical Specialist I include:

• Master?s degree in Life Sciences related field with 0+ years of experience OR
• Bachelor?s degree in Life Sciences related field with 2+ years of experience performing QC related activities within a biotechnology/biopharmaceutical company
• Experience within a GMP environment and knowledge of QC processes is strongly preferred

Compensation for the QC Analytical Specialist I includes:

• Salary Range: $70,000 - $85,000, commensurate of experience
• Full Benefits: Medical, Dental, Vision, 401k, STD, LTD, PTO, Paid Holiday, Sign-on Bonus, Annual bonus

Keywords:

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