Quality Assurance Senior Specialist

CooperCompanies•North Tonawanda, NY

19h•Onsite

About The Position

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

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 fast‑paced, regulated environment, with exceptional organizational, time‑management, and decision‑making 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.
5+ years in a cGMP‑regulated 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).
Bachelor’s degree in a Health, Engineering, or Scientific discipline required.

Nice To Haves

Advanced degree preferred.

Responsibilities

Contribute to the continuous improvement of site QMS elements ensuring alignment with cGMP and 21 CFR 210/211/820.
Establish, coordinate, and monitor risk‑based QC processes and controls across the site to sustain a compliant, inspection‑ready 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 risk‑mitigation actions are taken and documented in accordance with quality and regulatory requirements.
Coordinate end‑to‑end QC operations for incoming materials and finished product, ensuring sampling plans, test execution, and timelines comply with approved methods and procedures.
Ensure sample handling, chain‑of‑custody, and traceability of test samples
Champion data integrity and Good Documentation Practices (GDP); ensure all QC records are accurate, complete, contemporaneous, and audit‑ready.
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 third‑party 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 subject‑matter 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.