Senior Microbiologist

Responsibilities

• Manage IQ, OQ, and PQ of equipment, including protocol generation, execution, and final reporting
• Execute microbiological analysis and investigations aligned with Quality Systems and international regulations (USP, ACS, FDA, Ph. Eur, ASTM)
• Perform tasks under GMP, GLP, and GDP standards to ensure regulatory compliance
• Oversee the analytical method life cycle, including validation design, execution, revalidation, and archiving
• Manage the handover of analytical methods to the quality control laboratory through personnel training and procedure elaboration
• Track and trend microbiological analysis results across products, personnel, and environmental monitoring programs
• Lead investigations into out-of-specification results, non-conforming results, and CAPAs
• Serve as a Subject Matter Expert (SME) for strategic projects and during regulatory audits
• Collaborate with Regulatory Affairs and Complaints departments to maintain up-to-date documentation

Requirements

• Licenciatura in Microbiology (must be incorporated into the Microbiology Professional Association)
• Minimum of 5 years of experience in highly regulated industries such as medical devices or pharmaceutical manufacturing
• At least 3 years of experience with instrument and test method validation
• Proven experience in analytical method transfer
• Strong knowledge of international compendiums including USP, ACS, Ph. Eur, and ASTM
• Proficiency in English (85+ level) for reading, writing technical reports, and speaking
• Proficiency in Microsoft Office

Preferred Qualifications

• Specialization or Master’s degree in analytical methods or a quality-related field
• Experience working under ISO 17025, EU GMP, or FDA standards

About the Company

CooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting patients throughout their lifetimes, from contraception to fertility and birth solutions. As a division of CooperCompanies, we provide over 600 clinically relevant medical devices and innovative genomic testing solutions to healthcare providers worldwide.