QA Specialist II - Doc Control

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Position Title: QA Specialist II - Document Control

Location: Bedford, New Hampshire

Department: Quality Assurance, Document Control

Reporting To: Supervisor, Document Control

Responsible For (Staff): No

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.

ESSENTIAL DUTIES AND 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.

QUALIFICATIONS:

Required:

• 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 is required. 

• Previous Document Control and/or eQMS configuration and system management experience required.

• Advanced knowledge of cGMPs, EU regulatory requirements, and FDA 21 CFR Parts 210,211 and 820 and Industry best practices required.

• Working knowledge of Computer System Validation and Change Control requirements.

• Assist is leading large or cross-functional projects and improvement initiatives as assigned.

Preferred:

• 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.

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Equal Employment Opportunity (EEO) Statement:
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, affectional 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. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.