Job Description
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PURPOSE AND SCOPE:
Provides supervisory oversight to the department, analyzing production and quality control reports to identify nonconformities and operational issues, ensuring efficient and compliant production lines.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Supervise daily team operations, set goals, assign tasks, and manage schedules.
- Enforce clean room procedures.
- Troubleshoot machinery issues and assist maintenance as needed.
- Collaborate with management to set production and quality standards.
- Coordinate production with procurement and maintenance for optimal resource use.
- Develop methods to enhance product quality and resolve operational problems.
- Revise production schedules due to equipment failures.
- Consult engineering for equipment modifications.
- Plan production operations and inspect compliance with GMP.
- Develop and revise SOPs, ensuring worker compliance.
- Address worker grievances and maintain training on GMP and safety practices.
- Oversee hiring, training, and performance reviews.
- Assist with assigned projects and other duties as needed.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- Regularly use hands, stand, and walk during shifts; occasionally sit or climb.
- Lift/move 10-25 pounds regularly, up to 50 pounds frequently, and over 100 pounds occasionally with assistance.
- Exposed to moving mechanical parts and loud noise levels.
SUPERVISION:
May supervise various levels of manufacturing staff.
EDUCATION:
- Bachelors Degree required; relevant experience may substitute.
EXPERIENCE AND REQUIRED SKILLS:
- 2-3 years in a senior role or 1-3 years as a Supervisor.
- Knowledge of FDA guidelines and lean principles.
- Understanding of SPC and statistical techniques.
- Strong communication skills and proficiency in Microsoft Office.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity.
Fresenius Medical Care North America maintains a drug-free workplace.