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.
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.
Requirements / Qualifications:
Minimum of a Bachelors 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.
Numbers & Facts
Location
Bedford, MA
Skills
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Communication Skillsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Detail Orientedunmatched
Document Archivingunmatched
Document Controlunmatched
Document Managementunmatched
Documentationunmatched
Establish Prioritiesunmatched
External Auditunmatched
Gene Therapyunmatched
GxPunmatched
Information Technology & Information Systemsunmatched
Internal Auditunmatched
Manufacturingunmatched
Microsoft Excelunmatched
Microsoft PowerPointunmatched
Microsoft Wordunmatched
Multitaskingunmatched
Needs Assessmentunmatched
Off-Site Storageunmatched
Operational Supportunmatched
Operationsunmatched
Organizational Skillsunmatched
People Managementunmatched
Quality Controlunmatched
Reconciliationunmatched
Regulationsunmatched
Standard Operating Procedures (SOP)unmatched
Support Documentationunmatched
Team Playerunmatched
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