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Microbiology Method Transfer Scientist
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Insight Global
Raleigh, NC (In Person)
Full-Time
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Job Description
Job Description A global biopharmaceutical organization is seeking a Method Transfer and Validation Scientist to support the Quality Control organization within a regulated manufacturing environment. This individual will play a key role in transferring, validating, and maintaining microbiological test methods to ensure product quality, compliance, and operational readiness. This is a hands on laboratory role that requires strong experience with microbiology testing methods in a GMP environment. Key Responsibilities
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- Execute method transfer and validation activities for microbiological assays within a Quality Control laboratory
- Perform routine and non routine microbiology testing, including:
- Bioburden testing
- Endotoxin testing
- Sterility testing
- Microbial identification as needed
- Draft, execute, and review validation protocols, reports, and technical documentation
- Analyze and interpret laboratory data to ensure accuracy, completeness, and compliance with regulatory requirements
- Support investigations related to OOS, deviations, and assay performance and assist with root cause analysis and CAPA activities
- Collaborate cross functionally with Quality Control, Quality Assurance, Manufacturing, and MSAT teams to support successful method transfers and process readiness
- Update and maintain SOPs, test methods, and laboratory documentation to ensure continued compliance
- Ensure all activities adhere to cGMP standards, data integrity requirements, and regulatory guidelines
- Must be comfortable working either shift as follows:
Shift A:
Sun-Weds (4x10)Shift B:
Weds-Sat (4x10) We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review
Insight Global's Workforce Privacy Policy:
https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements- 3-5 years of post-graduate relevant experience
- Experience with various microbiology testing in the lab (Bioburden + Endotoxin is a must)
- Experience working in a pharmaceutical setting
- Experience supporting method validation, method transfer, or assay qualification activities