COMPLETE Supervisor, Inspection & Packaging, Ridgefield, New Jersey - Ridgefield, NJ

Supervisor, Inspection & Packaging          

2nd Shift: 12:00 PM - 10:30 PM M-TH

Note: The assigned shift hours and schedule are subject to change based on business needs.

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.

Job Description:

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.

• Managing and developing the performance of direct reports by setting clear “SMART” goals, providing timely performance feedback, recognizing and rewarding high achievers, and holding reports accountable for underperformance.

• 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 Sanofi’s 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.

Qualifications

• 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.

HSE

• It is required that individuals care for their own safety and wellbeing. Individuals must promote a safe working environment for employees and contractors working in their area of responsibility.

• The individual must support all Sanofi and site HSE policies as well as ensure that work performed is compliant with local HSE regulations.

• Individuals must complete all required HSE trainings. Everyone is required to report all accidents and incidents and support investigations in their areas of responsibility. Individuals must ensure timely closure of HSE actions owned by their departments.

• All area leaders are to complete required monthly Managerial Safety Visits (MSV).

 Education

• High School Diploma or GED with a minimum of 9 years relevant experience

• AA degree in science or engineering discipline with a minimum of 7 years relevant experience

• BS degree science or engineering discipline with a minimum of 4 years relevant experience

• Advanced degree (Masters/Doctorate) with a minimum of 6 months relevant experience.

Terms of employment

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, majority of the work activities are performed while standing. 

• 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

Based on production demands and personnel availability, different start time scenarios or additional hours may be required so a flexible work schedule is required for the candidate. Core Work hours for this particular position are as follows:

Benefits of working in this role

• This position wears many “hats” and requires frequent interaction with other departments.  This helps to facilitate career growth.

• Work with state-of-the-art inspection and packaging technologies.

• Be part of a team that strives to meet and exceed all production, quality, and safety expectations.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.