Senior Microbiologist

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

• Responsible for IQ, OQ and PQ of equipment, including generation of initial protocol, execution and final report. 

• Executes analysis, investigations, or proposal to improve procedures and processes aligned with the Quality System, regulations, and international organizations (e.g USP, ACS, FDA, Ph. Eur, ASTM).

• Performs tasks under Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), safety techniques and aligned with regulatory standards.

• Cooperates in lean initiatives such as 5S, process waste reduction, continuous improvement, Poka-Yoke solutions for quality and process event

• Serves as Subject Matter Expert (SME) for strategic and cross-functional special projects that drive operational excellence and continuous improvement. 

• Provides expert guidance in laboratory services, leveraging technical knowledge and industry best practices to support project planning, execution, and evaluation. 

• Collaborates with stakeholders across departments to identify opportunities for innovation, streamline workflows, and implement solutions that enhance quality, efficiency, and compliance.

• Support vendor coordination as needed, for equipment qualification and first calibration. 

• Responsible of analytical method life cycle including validation design, protocol, execution, final report, revalidation and archive.

• Responsible of analytical method handover to quality control laboratory, through training of personnel, certifying personnel and procedures elaboration. 

• Assists with review of the track and trend of the instrument’s failure modes, unscheduled PMs, spares replacement and diagnostic/root cause for failures. 

• Responsible for track and trend of microbiological analysis results across product, personnel, and environmental monitoring programs.

• Responsible of assigned track, trends and investigations of analytical methods failure, non-conforming results and CAPAs.

• Responsible for overseeing the reviewing and/or approval of internal laboratory investigation(s) when out of specification results are obtained. 

• Executes purchase orders when needed. 

• Interacts with vendors or third parties when needed. 

• Collaborate with stakeholders as Regulatory Affairs and Complaints to keep documentation up to date.

• Acts as principal investigator and contact with Technology Operations or Research and Development. 

• Fulfill role of microbiology laboratory regency. 

• Act as SME during audits.

• Reviewer and approval of specified Standard Operating Procedures.

• Other tasks required by the business. 

Travel: 

• Less than 10% travel requirement

Knowledge, Skills, and Abilities:

• Deep knowledge in microbiology, ELISA, immunochromatography, spectrophotometric assaysy, including determination of presence / absence of microbes, quantification of microbes, quantification of enzymatic activity, quantification of medicinal products and other 
• Ability to work independently and collaboratively, self-motivated, problem solving and decision-making skills, results-oriented ensuring accurate and timely completion of tasks while being an effectiveand teamwork player.
• Strong analytical skills
• Capability to work independently and manage multiple tasks with minimal supervision.
• Proficient in Microsoft Office.
• English level 85+ for reading, writing technical reports, speaking.

Work Environment:

• Prolonged sitting in front of a computer

Experience:

• A minimum of 5 years of previous work in highly regulated industries such as medical devices or pharmaceutical manufacturing is required.
• Experience with instruments and test methods validation of minimum of 3 years is mandatory
• Experience in analytical method transfer is required.
• Experience working under ISO17025 or EU GMP, FDA is required.
• Experience with international compendiums such as USP, ACS, Ph.Eur, ASTM is required.
• Strong command of microbiological concepts and tests is a must. Such as standardized strain management, Bioburden, Sterility testing, Endotoxin, Environmental Monitoring, ELISA, spectrophotometry, immunoassays, microbial identification, pathogen culture and identification, culture media quality control, validation of rapid methods

Education:

• Licenciatura in Microbiology. Incorporated to Microbiology Professional Association.
• Specialization or Master´s in analytical methods or quality related is highly desirable