Job Description

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 business unit of CooperCompanies (Nasdaq: COO), we're driven by a unified purpose of helping people 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 the 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 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.
• Serve as the designated professional responsible for the Microbiology Laboratory, if applicable
• Act as SME during audits.
• Reviewer and approval of specified Standard Operating Procedures.
• Other tasks required by the business.

• University Degree in Microbiology, Biotechnology, Biology or related fields
• Specialization or Master´s in analytical methods or quality related is highly desirable.
• Methods include deep knowledge in microbiology, ELISA, immunochromatography, spectrophotometric assays, including determination of presence / absence of microbes, quantification of microbes, quantification of enzymatic activity, quantification of medicinal products and other.
• 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.
• English level 85+ for reading, writing technical reports, speaking.
• Domain of microbiological concepts and test 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.
• Experience working under ISO17025 or EU GMP, FDA is required.
• Experience with international compendiums such as USP, ACS, Ph.Eur, ASTM is required.
• Ability to work independently, self-motivated, problem solving and decision-making skills, with assertive communication, results-oriented and teamwork player.