Hi, we got a new job opening for Manufacturing Documentation Specialist in Clinical Diagnostic Solutions, Inc.
Company : Clinical Diagnostic Solutions, Inc.
Location : Plantation, FL 33313
position : Manufacturing Documentation Specialist
Title Manufacturing Documentation Specialist
The Manufacturing Documentation Specialist is responsible for creating, reviewing, updating and/or obsoleting manufacturing documents. Assist with document writing related to investigations, protocols, or reports. Assist with documentation related to quality compliance (resolution of TAs, MRs, etc.) to support the manufacturing operation. Drive towards process flow improvements.
1. Understand responsibilities and structure of the manufacturing team.
2. Work closely with Control Manufacturing Area (CMA) and Reagent Manufacturing Area (RMA) Supervisor/Manager to review or update documentation as needed.
3. Make improvements to manufacturing documents such as batch records, RMSIs, SOPs, MWIs and other process-flow documents.
4. Create, modify, and obsolete Part Numbers, BOMs, and Routings in ERP system (Jeeves).
5. Understand the relationship between the documents, processes, and the structure of the part numbers and routings in Jeeves.
6. Obsolete other documents as needed.
7. Create new documents following existing templates, such as Labels, Label Accountability forms or RMSIs.
8. Process Action Notices and Temporary Authorities (TAs).
9. Assist in documentation related to Material Reviews (MRs).
10. Draft Change Notice (CN) requests and route for approval.
11. Inform Manager of any observed nonconformance with process, product, equipment, or area.
12. Perform other tasks as required by management.
13. Other projects and tasks as assigned
1. Able to understand written and verbal instructions in English.
2. Familiar with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
3. Proficient in Microsoft Word & Excel
1. High school degree required. Associates degree preferred.
2. Previous experience with documentation in FDA regulated industry preferred.
3. Positive attitude
Physical Requirements: 1. Light lifting < or equal to 25 lbs. Job Type: Full-time Pay: $60,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Employee discount Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance Schedule: 8 hour shift Monday to Friday COVID-19 considerations:Follow CDC guidelines. Education: High school or equivalent (Preferred) Experience: Manufacturing Documentation: 3 years (Preferred) Work Location: One location