Supervisor II

Ridgefield, NJ

Posted: 06/03/2019 Industry: Quality Assurance/Safety Job Number: 48973

Looking for applicants flexible and open to work two or more of the following shifts (Actual Shift will be determined during interview and/or when the offer is extended). 1st Shift A: Sun-Tues: 3AM-3: 15PM, Wed: 3AM-9: 15AM 1st Shift B: Wed: 9AM-3: 15PM, Thurs-Sat: 3AM-3: 15PM

The Inspection and Packaging Supervisor will oversee state-of-the-art commercial 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. Identifies technical/non-technical development gaps and implements applicable plans/objectives.

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.

Collaborate with supporting teams (e.g. QA, Warehouse, Planning, Facilities) to ensure all deliverables are met.

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 direct reports. Ensuring adherence to PM and validation schedules.

Participating in/leading scheduling, project, and staff meetings, providing updates of department activities and project statuses.

Ensure proper completion of Line Clearances in-between lots.

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, and assigned CCR tasks.

Participating in formal FMEAs and RAs.

Complying with requirements from Sanofis Safety Program including Health and Safety regulations and OSHA requirements.

Identifying and following up/leading opportunities to improve Inspection/Packaging line performance, changeovers, and OEE%.

Troubleshoots operational and equipment problems, and makes recommendations. Also coordinates emergency repairs and preventative maintenance activities with the facilities group.

Skills:

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. material flow, people flow, gowning requirements and utility systems).

Prior experience in visual inspection/packaging operations.

Prior experience supervising Inspection/Packaging lines for Pre-Filled Syringes preferred.

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.

Experience implementing Lean initiatives preferred. Ability to stand over intervals of several hours at a time Ability to bend, squat, and reach Ability to lift, push or pull various amounts of weight Education: High School Diploma or GED with a minimum of 7 years relevant experience AA degree in science or engineering discipline with a minimum of 5 years relevant experience BS degree science or engineering discipline with a minimum of 3 years relevant experience

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Lara Coghlan

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