Microbiologist 2

at  CooperSurgical

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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women’s healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women’s health care clinicians. More information can be found at www.coopersurgical.com .

The Quality Control Laboratory Microbiologist will provide support for analytical method validation, including design, protocol, execution, and report. The Microbiologist will also collaborate with senior scientists and leadership on new method and new equipment implementation and 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.

• Professional Lic. in Microbiology. Incorporated to Microbiology Professional Association.
• A minimum of 3 years of previous work in highly regulated industries such as medical devices or pharmaceutical manufacturing is required.
• Experience in analytical method transfer is required.
• English intermediate level 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 with international compendiums such as USP, ACS, Ph.Eur, ASTM is required.
• Ability to work independently, self-motivated, problem solving and decision-making skills, results-oriented and teamwork player.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

• Support equipment 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.
• Provide support for vendor coordination and support when needed, for equipment qualification and first calibration.
• Collaborate on analytical method validation design, protocol writing, execution and report writing.
• Support for 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.
• 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).
• Provide training for new hires as needed.
• 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 for optimization of current methods.
• Collaborates with stakeholders as Regulatory Affairs and Complaints to keep documentation up to date.
• Expertise in contamination control studies and environmental monitoring
• Back up for microbiology laboratory Regent.
• Other tasks required by the business.

Please refer the Job description for details