CooperSurgical

CooperSurgical is a globally provider of more than 600 products, each with a focus on improving the health of women, babies and families additionally is a Premier Provider of Medical Devices, Fertility and Genomics Solutions.

The Quality Laboratory Sr. Microbiologist will be responsible for analytical method validation, including design, protocol, execution, and report. Will be responsible of new method and new equipment implementation and will be responsible of the transfer of analytical methods to quality control routine operation through personnel training. Also, will be a key player in root cause investigations, CAPAs and OOS according to GLP, GMP, GDP and safety standards. 

CooperSurgical does not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, genetic characteristic, or other characteristics protected by law. Company policy also prohibits harassment of employees or applicants based on these characteristics.

• Responsible of equipment first qualification, including protocol writing, execution and report writing. 
• Methods include deep knowledge in microbiology, ELISA, immunochromatography, spectrophotometric assays, etc. For determination of presence / absence of microbes, quantification of microbes, quantification of enzymatic activity, quantification of medicinal products and other. 
• Responsible of vendor coordination and support when needed, for equipment qualification and first calibration. 
• Responsible of analytical method validation design.
• Responsible of analytical method validation protocol writing. 
• Responsible of analytical method validation execution
• Responsible of analytical method validation report.
• Responsible of analytical method validation revalidation and archive. 
• Responsible of analytical method handover to quality control laboratory, through training of personnel, certifying personnel and procedures elaboration. 
• Collaborates to keep track and trend of the instrument’s failure modes, unscheduled PMs, spares replacement and diagnostic/root cause for failures. 
• Responsible of keeping track, trends and investigations of analytical methods failure, non-conforming results and CAPAs. 
• Responsible of reviewing and/or approve internal laboratory investigation when out of specification results are obtained. 
• Executes purchase orders when needed. 
• Interacts with vendors or third parties when needed. 
• 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).
• Responsible of training for new hires.
• 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 events.
• Responsible of new methods research and acquisition, including new equipment implementation.
• Responsible of optimization of current methods. 
• Collaborates 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. 
• Possibility of microbiology laboratory regency. 
• Act as SME during audits.
• Other tasks required by the business.
• Professional Lic. in Microbiology. Incorporated to Microbiology Professional Association. 
• Specialization or Master´s in analytical methods or quality related is highly desirable. 
• 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.