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Senior QC Analyst, Microbiology - Permanent - Philadelphia PA

Join the team as a Senior QC Analyst and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.

Primary Responsibilities:

This position will be required to support quality control testing operations at our manufacturing site. You will focus on in-process and final drug product microbial testing, including bioburden, endotoxins, mycoplasma, gram stain, environmental monitoring, and sterility techniques. This role may require working across different shifts, including potential overtime, weekends, and holidays.

Skills & Requirements:

• Bachelor's degree in a relevant discipline (biological sciences or equivalent
• Minimum five (5) years of experience in the pharmaceutical industry within a Quality Control role
• Successfully interface with multi-disciplined teams
• Extremely detail-oriented with strong technical skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• High level of ownership and accountability
• Demonstrate a sense of urgency; ability to recognize time sensitivity.
• Previous experience with GDP, GLP, GMP Preferred Education, Skills, and Knowledge
• Advanced degree (MSc. preferred.)
• Experience with cell therapy products is a plus.

The Senior QC Analyst's responsibilities will be:

• Perform daily cGMP quality control laboratory microbiological testing activities at the iCTC facility.
• Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times..
• Support thorough cGMP investigations for out-of-specification test results.
• Support product stability programs, including execution of stability testing, stability data analysis, and final reporting of stability data.
• Support generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs, and change controls
• Perform peer review of laboratory data and logbooks.
• Provide input to functional laboratory and cross functional team meetings.
• Act as subject matter expert (SME) on one or more assays and train new laboratory personnel.
• Solid understanding and functional knowledge with hands on experience with the following: environmental monitoring, endotoxins, sterility, growth promotion, and mycoplasma.
• Proficient in performing technical writing (e.g., test methods, SOPs, protocols, deviations, CAPAs, change controls, etc.)
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• Work in a cleanroom with biohazards, human blood components, and chemicals
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

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