Lead QC Analyst, Microbiology
3 weeks ago
Overview
The Lead Quality Control Analyst - Microbiology will support quality control testing operations. The quality control testing programs include in-process and final drug product microbial testing and validation such as bioburden, endotoxins, mycoplasma, gram stain, environmental monitoring, and sterility techniques. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to complete assigned work.
Work shift: Mon-Fri 8AM-5PM
Essential Functions and Responsibilities
- Perform daily cGMP quality control laboratory microbiological testing activities at the iCTC facility.
- Support Gowning and Environmental monitoring Training and Qualifications.
- Perform environmental monitoring of the cleanroom areas as scheduled.
- Possesses and applies comprehensive knowledge of microbiology testing and Environmental monitoring to the completion of complex assignments like supporting validation studies.
- Operate at a consistent and exemplary level of efficiency, producing high quality accurate results.
- Conducts training on laboratory and Quality Control protocols.
- Authors and leads technical documents, such as test methods, operating procedures and work instructions for LIMS.
- Review technical documents for accuracy, update the SOPs per Change controls, thoroughness, and regulatory compliance.
- Train, Coach and Mentor other analysts on technical and testing issues.
- Develop and execute efficiency improvement projects.
- Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
- Perform all activities for cGMP compliance.
- Support thorough cGMP investigations for out-of-specification test results.
- Support technical problem-solving.
- 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.)
- Extremely detail oriented
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- Supports supervision with scheduling staff as needed.
- Support inspections as needed.
- Operate at a consistent and exemplary efficiency level, producing high-quality and accurate results.
- Work in a cleanroom with biohazards, human blood components, and chemicals
- Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
Required Education, Skills, and Knowledge
- Master’s degree preferred.
- Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
- Minimum 7 years of experience in the pharmaceutical industry within a Quality Control role with experience in method transfers, Change controls and Method validation.
- Strong background in technical writing, drafting reports and SOPs.
- 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 sense of urgency; ability to recognize time sensitivity.
Preferred Education, Skills, and Knowledge
- Experience with cell therapy products is a plus.
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