Supervisor, Production - Weekend

Overview

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

SUMMARY DESCRIPTION

The Supervisor, Packaging Operations is responsible for the skin packaging production activities for CMC (Collagen Manufacturing Center) to ensure the safety, efficacy, and quality of our medical devices. This includes assigning and monitoring weekend (Friday through Sunday) first shift activities of production staff and partnering with other support departments to efficiently and compliantly complete work and work processes as per outlined production schedules.

All production is to be conducted in compliance with ISO 7 and ISO 5 Clean Rooms and with Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOPs), and Health and Safety requirements. This job is expected to work onsite. This is a weekend-12 hours first shift from Friday through Sunday.

SUPERVISION RECEIVED

Under direct supervision of the Senior Manager, Manufacturing.

SUPERVISION EXERCISED

Directly supervises weekend first shift manufacturing cleanroom operators and lead operators.

• Ensures a safe working environment for all employees.
• Facilitates teamwork and cooperation with a focus on developing a Lean culture and high employee engagement and customer satisfaction.
• Ensures all established costs, quality, and delivery commitments are met, working within FDA medical device regulations and applicable ISO standards.
• Directs, coordinates, and evaluates the manufacturing area; ensures SOPs are properly followed.
• Provides daily coaching and development to direct reports.
• Reviews production and operating reports; participates in resolution of operational, manufacturing, and maintenance problems to minimize costs, prevent delays, and maintain quality and regulatory compliance.
• Trains and ensures employees are aware of and comply with company and regulatory procedures.
• Partners with Facilities, Maintenance, Engineering, Quality, Warehouse, and Planning to ensure seamless shift flow.
• Participates in investigative teams to resolve issues, including failure investigations related to manufacturing responsibilities.
• Reports non-conformances in a timely manner.
• Works with Quality to coordinate non-conformances (NC), Corrective and Preventive Actions (CAPA), and audit observations timely.
• Maintains gowning qualification for ISO 5 and ISO 7 Clean Rooms.
• Interviews, hires, trains, plans, assigns, and directs work; appraises performance and manages employee performance, addressing complaints and resolving problems.
• May perform other related duties, responsibilities, and special projects as assigned.

• Bachelor’s degree or higher in Science, Engineering, or related fields is desired.
• 3+ years of relevant leadership experience in a GMP regulated industry.
• Knowledge of NCs and CAPAs.
• Strong written and verbal communication skills with leadership ability and a team-focused approach.
• Ability to gown into ISO 7 and ISO 5 Clean Room environments.
• Batch manufacturing experience.
• Understanding of FDA regulations, ISO 9001, ISO 13485, and other applicable standards.
• Strong computer skills, including Microsoft Office;
  Oracle R12/Agile knowledge preferred.
• Lean/Six Sigma knowledge a plus.

Physical and Working Conditions

Reasonable accommodations may be made to enable participation in essential duties. The role requires ability to sit, listen, speak, and type; ability to access all areas of the company including manufacturing clean rooms; periodic lifting of up to 25 lbs; and standing for extended periods.

Adverse Working Conditions

General plant environment; potential exposure to hazardous and biohazardous materials including flammable and corrosive liquids, compressed gases, sharps, and medical wastes.

The duties listed are illustrative; the job description is subject to…