Document Control Specialist, Quality

Planet Pharma; Bedford (MA); On-site; USD 34,440 - 48,216; Full time

Job summary

Planet Pharma seeks a Document Control Specialist, Quality, to support document management lifecycle at our Bedford, MA site. The role emphasizes issuing and reconciling GxP documents while maintaining compliance with GDP and cGMP principles.

This CORE on-site position requires handling high volumes of documentation, audits, and collaboration with internal teams to uphold quality systems and regulatory standards.

Qualifications

• Bachelor's degree in a science, engineering, or related discipline.
• 1–4 years' experience in Quality with pharma/biotech or life-sciences exposure a plus.
• Experience in document control and electronic document management systems.

Responsibilities

• Adhere to SOPs, work instructions, and admin practices.
• Manage activities in the Document Storage Room at GTMF and GTQC.
• Organize and archive a high volume of documentation (electronic and paper).
• Assist with organizing and filing documents and records.
• Support issuance of controlled documents and audits/inspections.
• Provide GDP and cGMP guidance during daily activities.
• Communicate to assess interdepartmental needs and priorities.

Skills

Attention to detail

Organizational skills

Independent work

Effective communication

Education

Bachelor's Degree in science/engineering or related discipline

Tools

MS Excel

MS Word

MS PowerPoint

Job description

Target PR Range: 25-35/hr DOE

Document Control Specialist, Quality

Summary:

This rolewill work closely with members of the Document Control team and support routine daily operations for Document Management. The position will have someadditional 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.

This position is considered a CORE role and will require consistent on-site presence. It will support the Gene Therapy Manufacturing Therapy (GTMF) location in Bedford, MA.

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; escalatewhere appropriate.

Requirements

• 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.