What are the responsibilities and job description for the Documentation Specialist I-1st Shift position at Integrated Resources?
JOB DESCRIPTION :
The Production Specialist is responsible for ensuring that all production activities are scheduled and that documentation activities follow cGMPs. Also accountable to support manufacturing as needed based on production schedule. Review manufacturing BPR (batch production records) to ensure compliance with internal specifications and cGMPs. Scan and copy documents before submitting to QA. Manage cycle time for review and submission of documents. Creates Manufacturing schedule based on volumes. Review production schedule with various departments. Assures documentation follows cGMP regulations and ISO 13485 guidelines. Printing and Issuing of Batch Records, Protocols, and Labels for production. Drafts and reviews specifications, batch records, and standard operating procedures. Complete Athena-related transactions as needed. Initiates CAPAs and NCRs as required. Supports QA with document updates as needed. Monitors and trends batch record errors and provides manufacturing management with metrics. Assist Departments with documentation Improvement Projects. Perform data entry activities. Tracks KPIs for the department as needed. Leads team when required to perform support functions.
Education :
- High School Diploma or GED with 8-10years experience preferred
- Bachelors Degree with 1-3years experience preferred
Preferred Experience :
Skills :
