Quality Assurance Senior Specialist

CooperCompanies•City of North Tonawanda, NY

4h•Onsite

About The Position

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 www.coopersurgical.com. Work location: North Tonawanda, NY; Trumbull, CT; or Livingston, NJ (on-site). 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 inspection‑ready operation. This role supports the integrity and performance of the site’s Quality Management System (QMS) in alignment with cGMP requirements and 21 CFR Parts 210, 211, and 820. The position requires effective cross‑functional 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. The Quality Assurance Sr Specialist provides advanced quality oversight for QC testing operations across the North Tonawanda facility. This role ensures end‑to‑end control of incoming material testing and finished‑product 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.

Requirements

cGMP requirements
21 CFR Parts 210, 211, and 820
GDP and data integrity expectations

Responsibilities

Leading, coordinating, and executing all site Quality Control functions at the North Tonawanda, NY facility to ensure a compliant, efficient, and inspection‑ready operation.
Supporting the integrity and performance of the site’s Quality Management System (QMS) in alignment with cGMP requirements and 21 CFR Parts 210, 211, and 820.
Effectively collaborating cross-functionally 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.
Providing advanced quality oversight for QC testing operations across the North Tonawanda facility.
Ensuring end‑to‑end control of incoming material testing and finished‑product release activities.
Maintaining accurate and compliant records in accordance with GDP and data integrity expectations.
Initiating quality event investigations.
Managing the site stability program and external laboratory programs.
Coordinating equipment lifecycle activities.
Preparing QC documentation for internal and external audits.
Developing QC dashboards.
Supporting lean initiatives.
Collaborating cross functionally to strengthen QMS execution, improve operational efficiency, and support readiness for regulatory and customer inspections.