Brooksville, FL 34604 US
Title: Documentation Specialist
Location: Brooksville, FL
Salary: 65k and up based on experience
Employment Type: Direct Placement
Our client is a US-based sterile injectable manufacturer of parenteral drugs with a world-class facility focused on ready-to-use pre-filled syringes and vials. The company's product line includes small molecule 505(b)(2) NDA and 505(j) ANDA syringe and vial products, and it serves as an outsourced contract manufacturing partner for strategic pharmaceutical companies.
- Establish and manage the document control lifecycle of all QMS documents, including availability of documentation, accuracy, distribution, and periodic review.
- Checks format and conformance to document templates
- Performs general word processing tasks and support.
- Routes documents for review and approval in the electronic Document Management System
- Issuance, distribution, and review of controlled logbooks for all departments
- Coordinate revision and approval with document originators, and the resolution of document issues and discrepancies.
- Review documents for completion and accuracy.
- The position is the primary technical writer for documents pertaining to operations and quality, including policies, SOPs, master batch records, etc.
- Maintain storage and retention of documentation required for GMP activities; monitor the distribution and reconciliation of that documentation.
- This position is critical during a regulatory inspection in providing in a timely manner documents requested for review. May coordinate document/record requests and stage documents for presentation.
- Bachelor s degree preferred
- 2-4 years related experience in Quality Assurance or Operations and/or cGMP documentation role
- Experience in a cGMP regulated pharmaceutical sterile manufacturing environment (Preferred)
- Experience with cGMP Documentation e-Systems
- Experience with technical writing
- Previous role/experience as shop floor quality or operations associate (Preferred)
- Good verbal and written communication skills
- Experience with Microsoft applications