Document Control Specialist, Quality

Job Description

DOCUMENT CONTROL SPECIALIST, QUALITY

Location;
Bedford, MA

JOB DESCRIPTION

This role will work closely with members of the Document Control team and support routine daily operations for Document Management. The position will have some additional responsibility for documenting processes and supporting continuous improvement. This position will primarily be responsible for the processing and maintaining of GxP documents throughout their lifecycle with a focus on issuance and reconciliation.

KEY RESPONSIBILITIES

• Adhere to Standard Operating Procedures, Work Instructions, and other administrative practices.
• Manage activities associated with the Document Storage Room at both the GTMF and GTQC facilities.
• Organize and manage a high volume of documentation for archival in both electronic and paper-based processes.
• Assist with organizing and filing documents and records.
• Support issuance of controlled documents
• Assist with reconciliation, retention, and archival of documents and records.
• Retrieve documentation from document storage and/or offsite archival upon internal customer request
• Provide Document Control support in preparation of, during and after internal or external Audits/Inspections
• Provide guidance and support based on knowledge of GDP and cGMP principles during daily activities.
• Communicate effectively to assess daily interdepartmental needs and priorities; escalate where appropriate.

QUALIFICATIONS

• Minimum of a Bachelor's Degree in a science, engineering, or related discipline.
• 1-4 years' experience in Quality with experience in the pharmaceutical, biotech or other related life-sciences industry a plus.
• Experience in document control and electronic document management systems.
• Strong attention to detail and organizational skills, is required.
• Able to work independently, prioritize, and manage multiple tasks simultaneously.
• Demonstrates initiative and a strong sense of urgency.
• Proficient in MS Excel, Word, and PowerPoint.
• Effective teamwork and collaboration with internal and external SMEs.
• Knowledgeable in cGMP's and pharmaceutical industry regulations a plus.
• High ethical standards, good judgment, and professionalism.

Platinum Resource Group is a professional level consulting firm, providing resources to Fortune 1000 client companies in the areas of technology, human resources, accounting, finance, business systems and supply chain, on a contract and interim basis. PRG has operations in Orange County, San Diego, Los Angeles and San Francisco. As a W-2 employer we offer our consultants direct deposit bi-weekly payroll, health, dental, vision benefits, and referral bonuses.

Platinum Resource Group is a professional level consulting firm, providing resources to Fortune 1000 client companies in the areas of technology, human resources, accounting, finance, business systems and supply chain, on a contract and interim basis. PRG has operations in Orange County, San Diego, Los Angeles and San Francisco. As a W-2 employer we offer our consultants direct deposit bi-weekly payroll, health, dental, vision benefits, and referral bonuses.