Location: Buena, NJ
- Provide supervision and guidance in the execution of the production schedule to ensure completion in a timely and efficient manner.
- Complete all associated documentation to support the initiation, execution, and reconciliation of all compounding, inspection, and packaging line activities.
- Perform and/or support the production coordinator and inventory specialist in executing all the necessary component and product transactions in SAP.
- Work with Warehouse and Quality personnel to ensuring raw materials and packaging components are properly staged for each job.
- Work with Compounding and Packaging Line Leaders to coordinate temporary and permanent labor to staff the line as per standards.
- Train production line operators and compounders.
- Supervise line mechanics to ensure line set-ups are completed on time and as required.
- Ensures that all cGMP’s and procedures are followed by all personnel working on the production floor.
- Maintain a clean and safe work environment.
- Review logbooks in a timely manner.
- Review, edit, and generate SOP’s as required.
- Assist with the editing and improvement of batch records. Review all executed batch record upon completion of lot manufacture.
- Track line down-time by identifying root cause(s) and implement process improvements.
- Develop and manage the 6S Continuous Improvement process for their respective areas.
- Improve efficiencies and reduce waste.
- Report daily production data.
- Investigate manufacturing discrepancies within expected completion cycle time.
- Implement corrective and preventive actions (CAPA).
- Ensure proper aseptic manufacturing techniques are being followed for self and staff.
- Other duties as assigned by the Director of Topical Manufacturing, Aseptic & Media Program Manager and Director of Aseptic Manufacturing.
- Weekdays and/or weekend overtime may be required based on production needs.
- Bachelor’s degree or high school diploma and equivalent work experience.
- 3-5 years supervisory experience in a cGMP pharmaceutical environment.
- Excellent math and computer skills.
- Strong analytical and reasoning abilities.
- Participative management type-advocates team concept.
- Well-developed interpersonal skills. Ability to get along with diverse personalities.
- Good communication skills, both written and verbal.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- Employee is frequently required to stand for long periods of time; walk; use hands to handle or feel; and reach with hands and arms.
- Employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
- Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.