Document Control Specialist Quality

Platinum Resource Group; Bedford (MA); On-site; USD 60,000 - 85,000; Full time

Job summary

Platinum Resource Group in Bedford, MA is seeking a DOCUMENT CONTROL SPECIALIST, QUALITY to support daily operations for Document Management within a GMP environment. You will manage electronic and paper records, assist with audits, and help document lifecycle activities with a focus on issuance and reconciliation.

The role requires a Bachelor's in science or engineering, 1–4 years in quality, and strong attention to detail. Proficiency in MS Office and document management systems is essential.

Qualifications

• Bachelor's degree in science, engineering, or related discipline.
• 1–4 years of quality experience; pharma/biotech exposure a plus.
• Experience in document control and electronic document management systems.
• Strong attention to detail and organizational skills; able to work independently.

Responsibilities

• Adhere to SOPs, work instructions, and administrative practices.
• Manage activities in the Document Storage Room at facilities.
• Organize and manage high volume documentation for archival (electronic/paper).
• Assist with filing documents and records; support issuance of controlled documents.
• Assist with reconciliation, retention, and archival of documents and records.
• Retrieve documentation from storage or offsite archival per internal requests.
• Provide document control support during audits/inspections; ensure GDP/cGMP adherence.

Skills

Attention to detail

Organizational skills

Ability to work independently

Strong communication

Education

Bachelor's Degree in Science/Engineering

Tools

MS Excel

MS Word

PowerPoint

Job description

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; elevate 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.

Company Description

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.