Quality Control Scientist II
Lancesoft INC
Job Description
Job Description
6 Months contract
• BS degree in Biology/Microbiology with 10+ years or M.S. with 6+ years of relevant experience in a GMP QC microbiology laboratory.
• Demonstrated advanced expertise in microbiological testing including environmental monitoring, bioburden, endotoxin, sterility, mycoplasma and microbial identification.
• Experience supporting aseptic manufacturing environments and cleanroom operations.
• Demonstrated experience mentoring laboratory staff and providing technical training.
• Strong knowledge of cGMP regulations and microbiological control strategies.
Responsibilities:
• Serve as subject matter expert for microbiological testing programs including
environmental monitoring, sterility, endotoxin, mycoplasma, microbial identification, and
contamination control.
• Support QC Microbiology Senior Manager in oversight of laboratory operations,
technical initiatives, and microbiological program execution.
• Develop and deliver aseptic technique and contamination control training for
manufacturing and QC personnel to maintain compliance with GMP and cleanroom
practices.
• Track and support quality system activities including deviations, investigations, CAPAs,
Change Control and trending associated with QC microbiology operations.
• Review and approve microbiological data, protocols, quarterly reports , SOPs and
other technical documentation.
• Lead data trending and interpretation of environmental monitoring and microbiological
data to identify risks and support contamination control strategy.
• Provide technical leadership and mentorship to microbiologists and junior scientist
within QC microbiology laboratory.
• Author and review SOPs, protocols, validation reports, investigation reports and
technical documents in accordance with GMP requirements.
• Lead or support method qualification, validation, and technology implementation for
microbiological assays.
• Collaborate cross-functionally with Manufacturing, QA , Facilities and other teams to
support manufacturing operations and process improvements.
• Support regulatory inspections, audits and responses by providing technical
justification and documentation.
$74k - $85k
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