Supervisor, Manufacturing Operations - Contractor

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This is a temporary 6-month contracted 1099 position with no benefits.

POSITION SUMMARY:
The Manufacturing Operations Supervisor will be responsible for successfully leading a multi-shift production team of hourly and contract employees in the GMP manufacturing and packaging of pharmaceutical products at the Minnesota Operations Facility. In this role you will lead, coach and mentor the manufacturing team on lean manufacturing and production best practices to create a culture of engagement and continuous improvement while maintaining safety, quality, service, and cost goals. Daily execution and line performance as well as strong leadership are vital for this position. The successful candidate will be familiar with best practices for cGMP assembly and packaging of combination pharmaceutical products in a cleanroom environment.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
These may include but are not limited to:

• Following the requirements of cGMP – ensures all manufacturing and packaging are performed following written procedures and reports infractions to Manager of Manufacturing Operations.
• Plans cleaning, manufacturing, packaging, and documentation activities in a manner that maximizes efficiency.
• Facilitate and partner with cross functional teams such as quality, manufacturing engineering, and product development to ensure coordination of activities.
• Assisting with document/Batch Record review as “subject matter expert”.
• Promote safety, quality and compliance amongst the team while maintaining Good Manufacturing Practices
• Identifying manufacturing related issues, performing root cause analysis, and implementing solutions, as necessary.
• Communicates daily production activities and track performance against metrics to the Manager of Manufacturing Operations.
• Manage, motivate and develop manufacturing technicians through engagement, empowerment and collaboration.
• Monitor Quality Systems training for the Manufacturing Team. Assure assigned training is appropriate and completed on time.
• Identifying training opportunities, coaching and mentoring direct reports.
• Technical writing: creates or modifies documents utilizing change control and document revision systems to meet new or revised requirements.
• Administrative duties such as performance evaluations, merit increases, disciplinary interactions, and hiring activities.
• Take an active role in identifying continuous improvement opportunities, evaluating, and implementing solutions.
• Perform other related duties as assigned.

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES:

• High School Diploma or equivalent with 5-8 years of experience working in a production environment. Experience in the medical device or pharmaceutical industry, preferred. Associate’s Degree preferred.
• An equivalent combination of experience and education may be considered.
• Knowledge of Lean Manufacturing
• Experience with MS Office applications.
• Experience writing and reviewing technical documents and technical reports.
• Effective listening and communication skills, with capability to vary and combine leadership/communication styles based on needs of audience.
• Strong knowledge of Good Documentation (GDP) and current Good Manufacturing (GMP) Practices.
• Demonstrated experience in the training and development of employees in a manufacturing environment.
• Excellent organizational skills and ability to multi-task and adjust priorities, as necessary.
• Able to perform physical activity such as standing for long periods of time, walking, and working with hands.

ENVIRONMENTAL CONDITIONS:
Physical Activities: On a continuous basis, be at a desk for a long period of time; intermittently answer the telephone and type on a computer. Some walking and lifting up to 30 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical requirements described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities of this job. Laboratory Activities, if applicable: Biology and chemical laboratory environments experience needed. Environmental health and safety requirements also apply.

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