QA Specialist II - Doc Control

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow.

About the role

The QA Specialist II - Document Control will manage, coordinate, and maintain 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 as needed. The primary objective is to contribute to the maintenance and improvement of the Document Control program and its systems.

The QA Doc Control group is dedicated to the continuous improvement of the Document Change Control Lifecycle and Quality Systems to meet current compliance standards and ensure proper processing and release of controlled documents.

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. Perform internal audit tasks.
• Support metrics/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; and at least 10 years of industry experience with a minimum of 6 years document control experience in 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, and Industry best practices.
• Working knowledge of Computer System Validation and Change Control requirements.
• Assist in leading large or cross-functional projects and improvement initiatives as assigned.

Skills

• Superior professional communication skills across all levels of the organization, both written and verbal.
• Superior customer service.
• 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 System and associated tools.
• Excellent organizational skills and high efficiency.
• Excellent 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.

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