Coordinator, Production Document Control

Overview

POSITION SUMMARY: The Production Document Control Coordinator will review and obtain corrections for electronic batch records and verify Oracle transactions prior to submittal to Quality Assurance / Document Control. The Production Document Control Coordinator will also review and update the daily production numbers for the packaging and manufacturing departments and will assist the planning department with other documentation requirements.

Detailed Responsibilities/Duties

• Review and obtain corrections from Production Supervisors to assure electronic batch records are complete and correct prior to submittal to Quality Assurance/Document Control.
• Receive and review batch sheets, material issued forms, continuation forms, and pallet tag sheets.
• Perform distribution activities related to production documents.
• Update and maintain electronic tracking lists, document control databases, and document distribution binders and logs as needed for production requirements.
• Provide customer service and training to all employees needing assistance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Perform administrative tasks to support maintenance of manufacturing documentation and files.
• Review Manufacturing and Packaging batch records, ensuring all Oracle transactions are performed and completed properly.
• Avoid performing responsibilities in the Take Release Process, Procurement, etc.
• Ensure Production Work Orders are properly closed out financially before month’s end.
• Perform other related job duties as assigned or requested by the production and planning department or company management.

Qualifications

• Skills: Good interpersonal and communication skills. Excellent training skills. Good documentation practices. Ability to communicate effectively in English both verbally and in writing. Computer literacy with solid PC and software experience (Word and Excel). Ability to lift a minimum of 30 lbs. Able to work well individually and as a team member under the pressure of manufacturing. Strong organizational and time management skills.
• Experience: A minimum of one-year experience successfully reviewing and correcting documents in a GMP/manufacturing environment. Experience with SOPs.
• PREFERRED QUALIFICATIONS: Electronic Batch Record system and reconciliation knowledge. Oracle or related database experience. Experienced with Microsoft Office applications.