We have partnered with a global biopharmaceutical company that is looking for a Documentation Specialist to join their team in Exton, PA on a contract basis. The primary focus of the Documentation Specialist will be to manage the document archive and offsite storage and aiding in preparedness for audits and regulatory inspections.
The Documentation Specialist will have the following responsibilities:
- Performing editorial format reviews and proofreading functions of GMP documents
- Manage the document control archives and participate in inspection readiness
- Process all requests for creation, revision, review, approvals, issuance, and archival of GMP documents
- Maintain the security and traceability of electronic and hard copy GMP documents
- Document control projects and migration activites
The Documentation Specialist will have the following qualifications:
- Associate's Degree or Bachelor's Degree in a scientific or technical discipline
- Minimum of 3 years of document control experience, 5 years preferred
- Experience using electronic systems such as Veeva eDOCS, LIMS, LMS, TrackWise, etc.
This role is starting on a one year contract with the possibility of extension. Benefits and 401k provided.
This role is onsite in Exton, PA. As the position will be working with physical documents.
