Title: Manufacturing and Packaging supervisor II
Location: Ridgefield, NJ
Duration: 14 months+
Shift: 2nd and 3rd shift
Manager seeking to fill a 2nd and 3rd shift with each position. Please note at top of resume which shift (or both) candidate is willing to work.
Manufacturing and Packaging supervisor will oversee manufacturing and Inspection/ packaging operations.
Supervisor schedules shift tasks; ensures GMP compliance and safety; drafts and reviews manufacturing documents; troubleshoots; recruits; and coordinates with other departments by performing the duties listed below either personally or through subordinates. Additionally, the Supervisor is highly detail-oriented and schedule-driven, creates a culture of disciplined execution and a high level of professionalism for their team.
Major responsibilities for this role include but are not limited to:
Schedules and directs daily manufacturing and inspection/ packaging activities, timely communicating scheduling changes/issues to their staff, planning department and management.
Supervises manufacturing and inspection/ packaging operators – observing/instructing, coaching, leading and developing their staff.
Ensuring all manufacturing management tools/systems and documentation (eg. SOPs, OJTs) are accurate. Coordinates and drafts revisions of batch related documents, including batch records and SOPs. Reviews and approves batch related documents, ensuring the proper cGMP documentation practices are followed.
Ensuring timely issue escalation to manufacturing senior management and cross-functional support teams.
Ensuring that appropriate levels of trained resources are available to meet production schedules. Monitoring training of team members. Ensuring adherence to PM and validation schedules.
Ensuring Inspection Readiness of assigned manufacturing areas. Participating in inspections conducted by external regulators and ensuring success of audits for department.
Responsible for on-time completion of investigations, CAPAs for major and critical deviations and QEs.
Participating in formal FMEAs and RAs.
Complying with requirements from Client Client's Safety Program including Health and Safety regulations and OSHA requirements.
Identifying and following up/leading opportunities to improve manufacturing processes and practices.
Troubleshoots operational and equipment problems, and makes recommendations. Also coordinates emergency repairs, changeovers, and preventative maintenance activities with the facilities group.
" Good understanding of the operating principles for most processing equipment and scientific principles associated with their areas of responsibility. Understands the classification of the areas in facility (e.g. air pressure differentials, material flow, people flow, gowning requirements and utility systems).
- Prior experience in manufacturing and inspection/ packaging operations.
- Good oral and written communication skills. Experienced authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents.
- Practical knowledge and application of GMP regulations.
- Detail-oriented person with exceptional documentation practices.
Experience in managing multiple priorities in production environment and provide support to meet the manufacturing schedule while maintaining quality and compliance.
Experienced leading manufacturing teams to maintain adherence to a demanding production schedule.
Bachelor's Degree (BS/BA) from an accredited college or university in a relevant scientific or engineering discipline with 2 years of relevant experience, or an Associate's Degree (AS/AA) in the scientific or engineering discipline with a minimum of 4 years relevant experience, or a High School diploma with a minimum of 6 years relevant experience.