Technical Documentation Specialist II

CooperCompanies • North Tonawanda, NY

7h • Onsite

About The Position

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. 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

• Strong working knowledge of cGMP requirements and regulatory standards, including 21 CFR Parts 210, 211, and 820.
• Proven hands-on experience reviewing and approving batch production records, associated manufacturing documentation, laboratory records, and logbooks.
• Demonstrated experience managing controlled GMP documents across the full document lifecycle.
• Direct experience initiating deviations and nonconformances.
• Experience supporting internal audits and regulatory inspections (e.g., FDA, ISO), including document preparation and response support.
• Experience supporting or coordinating training programs and training record management within an electronic QMS.
• Demonstrated expertise in Good Documentation Practices (GDP) and data integrity principles (ALCOA+).
• Ability to serve as a Document Control SME, providing clear guidance on documentation standards, procedural compliance, and inspection readiness expectations.
• Strong understanding of Quality Management System (QMS) elements, including Document Control, Deviations, Nonconformances, CAPA, Training, Change Control, and Internal Audits.
• Excellent attention to detail with the ability to identify documentation errors, trends, and systemic issues.
• Strong organizational and time-management skills with the ability to manage competing priorities and meet deadlines in a fast-paced manufacturing environment.
• Effective written and verbal communication skills, with the ability to collaborate cross-functionally and influence without direct authority.
• Demonstrated analytical skills, including the ability to track, trend, and interpret quality and document control metrics.
• Proficiency in Microsoft 365 applications (Word, Excel, Outlook, PowerPoint, SharePoint).
• Hands-on experience administering or power-using electronic Quality Management Systems (eQMS) for document control, training, deviations, and CAPAs.
• Strong inspection-readiness mindset with the ability to maintain an audit-ready state at all times.
• Demonstrated continuous improvement and Lean mindset, with experience streamlining documentation workflows and reducing cycle times.
• Ability to work both independently and as part of a cross-functional quality team with a high level of accountability and professionalism.
• 4+ years of experience in a cGMP-regulated manufacturing environment (pharmaceutical, biologics, or medical device preferred) with demonstrated responsibility for batch record review and document control.
• Bachelor’s degree in a Health, Engineering, or Scientific discipline (or equivalent experience).

Nice To Haves

• Experience with additional regulated systems such as LIMS, ERP, or electronic batch record systems preferred.

Responsibilities

• Lead and perform quality review and approval of batch production records, associated manufacturing documentation, laboratory records, and logbooks, ensuring accuracy, completeness, and compliance with cGMP and approved procedures.
• Serve as the primary owner of site document control processes, managing controlled GMP documents throughout their full lifecycle (authoring support, review, approval, issuance, revision, archival, and obsolescence) in alignment with cGMP, 21 CFR Parts 210, 211, and 820.
• Act as the site Document Control Subject Matter Expert (SME), providing guidance and oversight on documentation standards, GDP expectations, and regulatory requirements; support cross-functional teams in resolving documentation-related issues.
• Champion data integrity and Good Documentation Practices (GDP) across site operations, ensuring all GMP records meet ALCOA+ principles and are maintained in an inspection-ready state at all times.
• Initiate, document, and manage deviations and nonconformance reports related to batch execution, documentation errors, and process gaps; ensure timely escalation, appropriate containment, and compliant documentation.
• Own and manage Corrective and Preventive Actions (CAPAs), including development of action plans, tracking execution, ensuring on-time closure, and verifying effectiveness to prevent recurrence.
• Drive and monitor the site’s periodic document review and reconciliation program, ensuring procedures, batch records, and controlled documents remain current, accurate, and compliant.
• Provide ongoing quality oversight of manufacturing and production support activities, proactively identifying compliance risks related to documentation, batch execution, and procedural adherence and recommending appropriate mitigations.
• Manage onsite and offsite controlled document storage, ensuring secure access, version control, retention, and retrieval in accordance with regulatory and corporate requirements.
• Serve as a system administrator for the electronic Quality Management System (eQMS) related to document control and training records; ensure accurate system use and data integrity.
• Support site training programs by assisting with curriculum updates, document-based training, and maintenance of accurate training records to ensure personnel qualification and compliance with QMS requirements.
• Support internal audits and regulatory inspection readiness activities, including document preparation, audit participation, response development for documentation-related observations, and follow-up on assigned actions.
• Develop and track document control and batch review metrics (e.g., right-first-time, review cycle times, overdue documents, CAPA trends) and communicate trends, risks, and improvement opportunities to site Quality leadership.
• Apply Lean and continuous improvement principles to enhance batch review efficiency, reduce documentation errors, streamline workflows, and strengthen overall quality system effectiveness.

Benefits

• great compensation package
• medical coverage
• 401(k)
• parental leave
• fertility benefits
• paid time off for vacation, personal, sick and holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees