Quality Assurance Senior Specialist

About CooperSurgical

CooperSurgical is a leading fertility and womens 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 were driven by a unified purpose to enable patients to experience lifes 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 womens 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: North Tonawanda NY; Trumbull CT; or Livingston NJ (on-site)

Scope:

The Quality Assurance Sr Specialist is responsible for leading coordinating and executing all site Quality Control functions at the North Tonawanda NY facility to ensure a compliant efficient and inspectionready operation. This role supports the integrity and performance of the sites Quality Management System (QMS) in alignment with cGMP requirements and 21 CFR Parts 210 211 and 820. The position requires effective crossfunctional collaboration with Manufacturing Engineering Validation and Quality to maintain product quality resolve quality issues assess and mitigate risk and drive continuous improvement across laboratory and QC processes.

Job Summary:

The Quality Assurance Sr Specialistprovides advanced quality oversight for QC testing operations across the North Tonawanda facility. This role ensures endtoend control of incoming material testing and finishedproduct release activities while maintaining accurate and compliant records in accordance with GDP and data integrity expectations. Responsibilities include initiating quality event investigations managing the site stability program and external laboratory programs coordinating equipment lifecycle activities and preparing QC documentation for internal and external audits. The Sr Specialist also develops QC dashboards supports lean initiatives and collaborates cross functionally to strengthen QMS execution improve operational efficiency and support readiness for regulatory and customer inspections.

• Contribute to the continuous improvement of site QMS elements ensuring alignment with cGMP and 21 CFR 210/211/820.
• Establish coordinate and monitor riskbased QC processes and controls across the site to sustain a compliant inspectionready state.
• Provide quality oversight of operational activities to ensure full adherence to site procedures cGMP requirements and applicable regulatory standards.
• Identify escalate and initiate investigations for nonconformance events ensuring immediate riskmitigation actions are taken and documented in accordance with quality and regulatory requirements.
• Coordinate endtoend QC operations for incoming materials and finished product ensuring sampling plans test execution and timelines comply with approved methods and procedures.
• Ensure sample handling chainofcustody and traceability of test samples
• Champion data integrity and Good Documentation Practices (GDP); ensure all QC records are accurate complete contemporaneous and auditready.
• Assist in the review of batch production records and logbooks; resolve documentation gaps and drive systemic preventive actions.
• Administer the site stability program: protocol adherence pull schedules testing coordination data review trend analysis and reporting per governing procedures.
• Manage outsourced testing with qualified thirdparty laboratories; ensure method alignment timely results and complete documentation.
• Maintain effective relationships and communication with external testing calibration and supplier partners; monitor service quality and performance.
• Oversee QC laboratory equipment calibration and performance verification; maintain equipment status control and records.
• Ensure routine laboratory cleaning safety and housekeeping to maintain continuous inspection readiness.
• Prepare QC documentation and act as a subjectmatter representative during internal customer and regulatory audits; coordinate responses and CAPA commitments through to closure.
• Partner with Operations to coordinate operator qualifications and maintain competency matrices.
• Serve as the QC liaison to Manufacturing Engineering Validation Regulatory and Quality for compliant execution and timely issue resolution.
• Develop and maintain QC tracking tools/dashboards to monitor performance trends and risks; communicate insights to site leadership.
• Apply Lean and continuous improvement methodologies to streamline QC workflows reduce cycle time and eliminate waste.
• Control QC reagents and laboratory supplies: forecasting ordering receipt status labeling storage and reconciliation in electronic inventory systems.
• Perform other duties as assigned.

Travel:This position may require 10-20% domestic and/or international travel.

Knowledge Skills and Abilities:

• Expert knowledge of cGMP requirements and 21 CFR Parts 210/211 with strong working familiarity with 21 CFR 820 and key Quality Management System (QMS) elements including Deviations CAPA Change Control Document Control and Audit Readiness.
• Demonstrated ability to manage multiple priorities in a fastpaced regulated environment with exceptional organizational timemanagement and decisionmaking skills; able to work independently with minimal direction while maintaining a high level of accountability.
• Mastery of Good Documentation Practices (GDP) and data integrity principles with meticulous attention to detail in reviewing authoring and approving GMP documentation ensuring accuracy completeness and compliance.
• Advanced proficiency in Microsoft 365 (Outlook Word Excel PowerPoint SharePoint) and strong capability with electronic quality systems such as LIMS ERP and electronic deviation/CAPA systems; able to analyze data generate reports and support digital workflow improvements.
• Strong verbal and written communication skills with the ability to effectively collaborate across functions provide clear quality guidance and influence peers and partners without direct authority.

• Proven initiative and continuous improvement mindset demonstrating the ability to identify inefficiencies recommend process enhancements and lead or support change efforts using Lean or other improvement methodologies.

Work Environment:

• Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting standing or getting up and down throughout the day.
• Occasionally lift to 35 pounds.

Experience:

• 5 years in a cGMPregulated manufacturing environment (pharmaceutical or medical device) with demonstrated leadership in QC coordination investigations and QMS execution.
• Experience managing outsourced testing and equipment lifecycle activities (calibration/PM).

Education:

• Bachelors degree in a Health Engineering or Scientific discipline required. Advanced degree preferred.

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Our Benefits:

As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us atto learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.

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 payfor this role is between$90000.00 - $115000.00 annually. Theactual base payincludes 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.