Biotech and Pharmaceutical, Communication Skills, Current Good Manufacturing Practice (cGMP), Documentation, Dosage Forms, ERP (Enterprise Resource Planning), GMP (Good Manufacturing Practices), Operations Processes, Policy Development, Printing, Procedure Development, Production Management, Production Schedule, Safety Standards, Standard Operating Procedures (SOP), Supply Chain Management, Team Player, Time Management
REPORTS TO: Supply Chain Supervisor
POSITION SUMMARY:
Under general supervision and instructions, receive, sample, and document incoming material ensuring they meet specification. Responsible for the labeling and packaging of pharmaceutical products following cGMP, and Safety standards while maintaining a teamwork attitude to effectively manage production needs and meet the production schedule.
PRINCIPAL DUTIES:
- Perform receipt of incoming materials per written procedures and specifications and record transactions within the ERP system
- Perform printing, labeling and final packaging execution activities as assigned per appropriate procedures using appropriate automated systems in place with a focus on quality and efficiency.
- Works on assignments that are routine in nature but may recognize the need for occasional deviation from standard practices.
- Safely, setup, operate, and adjust equipment and GMP systems, as appropriate.
- Checks for the line #, date, product name, strength, dosage form, lot number, and package size against the packaging filling record.
- Operates automatic labeling and sealing equipment.
- Performs cleaning of the packaging room and equipment as stated in the SOPs.
- Maintains a clean and functioning work area.
- Complete appropriate process related documentation (including but not limited to the following: batch records, room/equipment use logs, etc.) per cGMP.
- Makes limited decisions; operates within established policies and procedures.
- May make recommendations to management on operating policies and procedures.
- Effectively communicate all process related issues to production Lead/Supervisor, when necessary.
- Performs other duties and projects assigned.
QUALIFICATIONS AND EXPERIENCE:- High School Diploma/G.E.D. or equivalent required
- 0-4 years of related experience