Job Description

Job Description

Job Responsibilities:

• Develop, evaluate, and optimize the QC method transfer program for both analytical and microbiological assays.
• Assess incoming client methods and compendial test methods for raw materials, container/closures, APIs, in-process samples, and finished products, determining suitability with existing laboratory capabilities and identifying any additional instrumentation or reagents required.
• Collaborate with clients and internal teams to plan, review, approve, and execute method transfers into the laboratory.
• Work closely with the Quality team to maintain and enhance laboratory safety programs and promote a quality-driven culture.
• Maintain rigorous scientific and quality standards, ensuring accuracy, reproducibility, and compliance in all laboratory activities.
• Coordinate resources, scheduling, and logistics to support client testing needs, including microbiological sampling, laboratory instruments, and personnel availability.
• Ensure laboratory readiness for inspections, audits, and regulatory compliance by applying knowledge of cGMP, cGLP, and other regulatory standards.
• Lead and support investigations for out-of-specification (OOS), out-of-trend (OOT), and other non-conformance events using troubleshooting and corrective action processes.
• Manage laboratory documentation and technical records throughout their lifecycle, including authoring, reviewing, approving, and retiring procedures and reports, utilizing both manual and automated systems.

Qualifications:

• Bachelor’s degree in Biology, Microbiology, Biochemistry, or related field.
• 5+ years of experience in microbiology or related roles within GMP manufacturing or QC laboratory testing.
• Practical experience implementing FDA, EMA, and other regulatory authority expectations for QC, particularly regarding method development and method transfer.
• Proficiency with laboratory instrumentation and automated data management systems (e.g., LIMS, JMP, Minitab).

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