Documentation Specialist - Quality Systems & GMP Archive
The company is a multinational pharmaceutical company that successfully focuses on new areas of cancer immunotherapy.
We are seeking a highly motivated individual to join our client as a Quality Systems - Document Specialist I reporting to the Quality Systems Document Control Senior Manager. You will work in Quality Assurance team in supporting our efforts in this exciting new area of cancer immunotherapy. You will be responsible from GMP archive and digitization of GMP records. You will work closely with other departments when there is an archival/retrieval request ensure availability of documents timely and right first time.
The Quality Systems Document Specialist is responsible from scanning and uploading GMP records to Electronic Document Management System to electronically store GMP records.
Additional job duties include:
- Responsible for the management of all document issuance and archival processes to support GMP operations.
- Issue logbooks.
- Identify and escalate compliance gaps across the document archive system
- Investigate deviations against the document archive system and develop/execute effective corrective action plans.
- Support audits (internal, external)
- Perform other duties as required.
The ideal candidate for this position has an eye in detail and works in an organized/structured manner.
- 2+ years of relevant document archiving experience in a regulated area (Pharma, Meddev, Food, Chemicals, etc.).
- Demonstrates working knowledge of Document archiving.
- Demonstrates good interpersonal communication skills in English.
- Demonstrates knowledge in Microsoft Office applications (Word, Excel, Adobe).
- Detail oriented, methodical and strong ownership
- Organized, with excellent administrative skills
- Able to work in a team
- Comfortable in a fast-paced environment with minimal direction.