Life Science Quality Assurance Specialist III

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 Work location: Livingston, NJ (on-site) Scope The Life Science Quality Assurance Specialist III is a senior‑level employee who reports to the Life Science Quality Manager. The role owns Quality System(s), facilitates meetings, provides data from tracking and trending, leads quality and continuous improvements, trains the organization on the Quality System(s), mentors Quality Team members, and drives change that remediates risks to internal and external customers. Job Summary The Life Science Quality Assurance Specialist III is primarily responsible for establishing, developing, implementing, maintaining and improving Quality System processes and programs to include: Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA, Complaint), Document Control Program, Supplier Qualification, Validations, and Product Transfer. The candidate will mentor and train new personnel on the Quality System(s) and partner with stakeholders to improve the quality program and culture within the organization. Strong written and verbal communication skills, cross‑functional collaboration, positive influence, high integrity, and a continuous improvement mindset are required. Responsibilities Maintain a culture of quality awareness, teamwork, and cooperation with Quality customers. Provide Quality oversight, support and engagement as needed by Operations. Owner of Quality Management System Processes such as: Document Control Program: review, approval, and maintenance of company SOPs via an electronic Document Quality Management System. Change Management Program: review, approve, and track changes to approved procedures, validated software and processes, and qualified equipment; review task completion. Deviations and Nonconformances: review, approve, and monitor events and deviations; handle complaints and investigations. Track and facilitate investigations in cross‑functional team discussions to support closing of Quality Events, Change Controls and CAPA. Supply/Vendor Management: supplier qualification, reassessment activities, quality agreements, quality score cards; oversee process maintenance and approval. Audit Program: aid in tracking and trending of internal and external findings; investigate and implement corrective/preventive measures. Validations: review and approve equipment, systems validation/qualification, and any design transfer to operations. Quality Metrics: perform trending analysis and reporting of quality indicators; identify risks and process improvements for operations. Review charts and medical records for completeness of all required testing and documents for various processes. Facilitate meetings, provide system visibility, communicate status, and facilitate closure of aging items. Gather performance metrics and coordinate Management review inputs from various contributing departments. Track, trend, and report Quality System metrics to ensure continuous quality improvements while communicating critical compliance and quality risks. Work cooperatively in a team environment to maintain cross‑functional and cross‑site process and procedural consistency for quality systems records. Create and implement a training program for the QMS processes to educate Quality Assurance customers. Perform other Quality Assurance duties as required. Qualifications Knowledge, Skills and Abilities: Understands and applies comprehensive knowledge of quality principles and maintains current understanding of regulations. Familiarity with basic statistics, risk tools, technical writing, and review/approval of investigations. Computer Skills: Knowledge of Master Control or similar eQMS a plus. Proficiency in Microsoft Office applications: Word, Excel, and PowerPoint. Adaptability: Responds effectively to changing constraints. Good interpersonal skills; works efficiently in a team environment. Understands drivers of change and anticipates implications of changing circumstances. Applies a preventative rather than corrective approach; attention to detail. Checks information, identifies inconsistencies and mistakes, and makes detailed comparisons. Positive work attitude that supports teamwork and continuous improvement. Decision Making: Makes pragmatic decisions based on a range of factors. Can make decisions quickly when necessary, even with incomplete information. Demonstrates logic to back up decisions. Excellent critical analytical skills – ability to find root causes of issues. Initiative: Identifies ways to improve processes and situations. Takes responsibility for improvements or problem solving. Displays eagerness to learn and continuously improve. Sets own standards above prevailing standards; shows dissatisfaction with substandard activities. Interpersonal skills: socially capable, interacts confidently, reads situations, evaluates reactions, collaborates. Results Oriented: Focuses on important issues only; risk‑based approach. Regularly refocuses on results. Drives to exceed performance targets. Task Management: Handles multiple tasks and competing priorities concurrently and timely. Prioritizes and monitors task progress. Estimates time and resource requirements realistically. Work Environment Physical demands include sitting, talking, occasionally standing, walking, using hands to handle or feel objects, and reaching with arms; specific vision requirements include close vision. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Education Bachelor’s degree (BA) from a four‑year college or university, or Associate’s degree (A.A.) with four to six years of related experience and/or training. OR six to eight years of related experience and/or training. OR an equivalent combination of education and experience. Experience Must have knowledge and proficiency in the Quality Assurance Specialist II role. Must demonstrate knowledge of regulations and standards such as CLIA (42 CFR 493), FDA (21 CFR 820), ISO 15189 for Medical Laboratories, AABB, FDA (HCT/P, cGMP, cGTP), 21 CFR 1271, FACT, and ISO 9001. Benefits As an employee of CooperSurgical, you’ll receive a comprehensive total compensation plan that includes medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. For more information, visit 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. For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $90,000 and $115,000. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits. #J-18808-Ljbffr CooperSurgical