Technical Documentation Specialist II
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) Scope: The Technical Documentation Specialist II is responsible for providing critical quality oversight of batch and production-related documentation and for ensuring the effective execution of site document control processes within a cGMP-regulated manufacturing environment. This role serves as the primary owner of controlled GMP documentation and supports the ongoing compliance, integrity, and continuous improvement of the site Quality Management System. Job Summary: The Technical Documentation Specialist II provides comprehensive quality oversight for the site’s batch record review and document control systems, ensuring that all GMP documentation is accurate, complete, compliant, and inspection-ready. This role manages the full lifecycle of controlled documents within the electronic Quality Management System (eQMS) and reinforces Good Documentation Practices (GDP) and data integrity (ALCOA+) standards across site operations. Key responsibilities include leading batch and production document review activities; initiating deviations and nonconformance reports; owning and driving document related Corrective and Preventive Actions (CAPAs); and maintaining controlled document repositories. The Document Control Specialist also supports training administration, internal audits, and regulatory inspection readiness while developing and monitoring document control and batch review metrics to identify trends, risks, and improvement opportunities. Through strong technical expertise, attention to detail, and a continuous improvement mindset, this role plays a critical part in maintaining compliance, supporting reliable product release, and strengthening the effectiveness and sustainability of the site Quality Management System.
Requirements
- Technical expertise
- Attention to detail
- Continuous improvement mindset
Responsibilities
- Providing critical quality oversight of batch and production-related documentation.
- Ensuring the effective execution of site document control processes within a cGMP-regulated manufacturing environment.
- Serving as the primary owner of controlled GMP documentation.
- Supporting the ongoing compliance, integrity, and continuous improvement of the site Quality Management System.
- Providing comprehensive quality oversight for the site’s batch record review and document control systems.
- Ensuring that all GMP documentation is accurate, complete, compliant, and inspection-ready.
- Managing the full lifecycle of controlled documents within the electronic Quality Management System (eQMS).
- Reinforcing Good Documentation Practices (GDP) and data integrity (ALCOA+) standards across site operations.
- Leading batch and production document review activities.
- Initiating deviations and nonconformance reports.
- Owning and driving document related Corrective and Preventive Actions (CAPAs).
- Maintaining controlled document repositories.
- Supporting training administration, internal audits, and regulatory inspection readiness.
- Developing and monitoring document control and batch review metrics to identify trends, risks, and improvement opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
501-1,000 employees
