QA Specialist II - Doc Control

Location: Bedford, New Hampshire | Department: Quality Assurance, Document Control

About the role

The QA Specialist II - Document Control manages, coordinates, and maintains cGMP documentation, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived. This role evaluates document needs, participates in processing documents and records, maintains databases and Quality Management System tools, and supports personnel and functional areas. The primary objective is to contribute to the maintenance and improvement of the Document Control program and its systems.

Responsibilities

• Maintain Quality System Master Documents and Master Document List.
• Facilitate workflows in the electronic document management system and legacy paper processes.
• Perform the creation, modification, and approval of Client Batch Records independently.
• Issue and reconcile batch records, testing data capture sheets, lab books, equipment log books, room log books, and Quality System event documents.
• Maintain Document, Material, and Batch numbering logs.
• Write and develop QA SOPs with minimal oversight.
• Administer the maintenance of the Record/Document filing system at designated sites.
• Proof and edit document changes, including minor SOP updates, as directed.
• Participate in or lead audit preparation and reconciliation; support audit requests and perform internal audit tasks.
• Support metrics and report generation.
• Cross-train and provide support for coverage of multiple production facilities as needed; cover absences.
• Lead continuous improvement efforts and projects across the department or multiple departments; provide input and propose resolutions.
• Perform obsolete and administrative document workflow within Master Control.
• Lead Quality System Investigation and CAPA action items.
• Train others in document control processes.
• Develop and implement new tools and processes for Document Control with minimal oversight.
• Participate in or facilitate functional area programs.

Requirements

• High School Diploma; at least 10 years of industry experience with a minimum of 6 years in document control within the Biotech, Pharmaceutical, or Medical Device industries.
• Previous Document Control and/or eQMS configuration and system management experience.
• Advanced knowledge of cGMPs, EU regulatory requirements, and FDA 21 CFR Parts 210, 211, and 820, as well as industry best practices.
• Working knowledge of Computer System Validation and Change Control requirements.
• Ability to assist in leading large or cross-functional projects and improvement initiatives as assigned.

Qualifications

• Superior professional communication skills, both written and verbal, across all levels of the organization.
• Strong customer service orientation.
• Ability to identify and lead large or cross-functional projects and improvement initiatives.
• May support more than one production facility.
• Expert skill level in MS Office, general computer use, and electronic Quality Management Systems and associated tools.
• Excellent organizational skills and high efficiency.
• Strong attention to detail.
• Ability to perform repetitive tasks with a high level of detail, requiring decision-making on daily tasks and improvement initiatives.
• Sound decision-making ability; recommend solutions to Management for critical decisions.