QA Specialist II - Doc Control

The individual will manage, coordinate, and maintain cGMP documentation, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived. The Document Control QA Specialist II will evaluate document needs and participate in the processing of Documents and Records, maintain databases and Quality Management System tools and supports personnel and functional areas as needed. The primary objective of the Document Control QA Specialist II will be 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; Facilitates workflows in the electronic document management system and legacy paper processes; Performs the creation, modification, and approval of Client Batch Records independently; Issues and reconciles batch records, testing data capture sheets, lab books, equipment log books, room log books, and Quality System event documents; Maintains Document, Material and Batch numbering logs; Writes and develops QA SOPs with minimal oversight; Administers the maintenance of the Record/Document filing system at designated sites; Proofs and edits document changes including minor SOP updates, as directed; Participate in or lead audit preparation and reconciliation. Support audit requests. Perform internal audit tasks; Supports metrics / report generation; Cross-trains and provides support for coverage of multiple production facilities as needed. Covers absences; Lead continuous improvement efforts and projects across the department, or multiple departments. Provide input, propose resolutions; Performs obsolete and administrative document workflow within Master Control; Leads Quality System Investigation and CAPA action items; Train others in doc control processes; Develops and implements 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 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 is leading large or cross-functional projects and improvement initiatives as assigned.

Nice to have

Superior professional communication skills across all levels of the organization written and verbally; Superior customer service; 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 uses and the electronic Quality Management System and associated tools; Excellent professional written and verbal skills. Team oriented; Excellent Organizational skills. Highly Efficient; Excellent attention to detail; Perform repetitive tasks with high level of detail, requiring decision making on daily tasks and improvement initiatives. Sound decision making ability required. Recommend solutions to Management for critical decisions.