Document Control Specialist, Quality

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.
• Absorb and 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.
• Communicate effectively to assess daily interdepartmental needs and priorities; escalate where 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.