QA Specialist II - Doc Control

Position Title

QA Specialist II - Document Control

Bedford, New Hampshire

Quality Assurance, Document Control

Supervisor, Document Control

Responsible for managing, coordinating, and maintaining cGMP documentation, procedures, and records to ensure controlled copies are reviewed, approved, issued, distributed, and archived. The role evaluates document needs and participates in processing of documents and records, maintains databases and Quality Management System tools, and supports personnel and functional areas.

• 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

• High school diploma and at least 10 years of industry experience, with minimum 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
• Ability to assist in leading large or cross-functional projects and improvement initiatives
• Superior communication skills across all levels of the organization, written and verbally
• Superior customer service skills
• May support more than one production facility
• Expert skill level in MS Office, general computer usage and the electronic quality management system and associated tools
• Excellent organizational and attention to detail skills
• Ability to perform repetitive tasks with high level of detail requiring decision making on daily tasks and improvement initiatives
• Sound decision making ability and recommend solutions to management for critical decisions

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, equity and inclusion are at the core of our company’s purpose:
Together, delivering life‑changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level.