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Document Control Specialist, Quality
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.Â
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:
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; escalate where appropriate.
- 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.Â
- 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.
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Explore exciting job opportunities in and around Bedford, Massachusetts! Located in Middlesex County, just a short drive from Boston, this charming town offers a perfect blend of suburban tranquility and urban convenience. With close proximity to historic sites like the Bedford Flag and the Minute Man National Historical Park, as well as a thriving arts scene showcased at the Higgins Art Gallery, job seekers can enjoy a rich cultural experience while advancing their careers. Indulge in delicious New England cuisine, catch a show at the nearby Merrimack Repertory Theatre, or cheer on the beloved Boston Red Sox at Fenway Park. Embrace the picturesque beauty of nature at nearby Bedford Center Park or take a stroll by the Concord River. Don't miss the chance to grow both personally and professionally in this vibrant and dynamic region!