Fractionation Manufacturing Supervisor

Role Summary

The supervisor position implements and supervises daily activities in a specific production area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (GMPs), environmental health and safety (EHS) guidelines and any other regulations that could apply. May manage labor resources.

Responsibilities

• Oversee the daily manufacturing operations in an area. Maintain (audit, refine, improve) equipment and processes within this area.
• Provide a positive and equitable working environment emphasizing respect, responsiveness and results.
• Support and emphasize the Safety and Quality commitments of the department. Make decisions concerning these commitments within the area.
• Use resources and raw materials in the most efficient and productive manner possible.
• Identify resources in an area to assist the superintendent to meet the annual operational plan and budgetary commitments.
• Facilitate and verify appropriate training for employees in the area (including GMP, job skills, safety).
• Ensure compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements.
• Commit to employee feedback and developmental process ‚Äì support Talent Management goals, conduct recognition and disciplinary action for employees, facilitate employee representation throughout the organization.
• Submit and maintain and distribute reports related to attendance, labor, efficiency, safety, scrap and others.
• Utilize resources and raw materials in the most efficient and productive manner possible.

Qualifications

• Typically requires bachelor's degree in science, engineering or other related technical field. 3+ years of related experience with 1+ years in a supervisor role.
• Work with well with other departments and lead in a team environment.
• Experience preparing technical reports.
• Understand GMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
• Work with all levels of personnel manufacturing, Quality, documentation, and personnel issues.
• Collect and analyze data and information to determine paths for process improvement and potential root cause/corrective actions in the case of exceptions.

Additional Requirements

• Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
• Must be able to stand for extended periods of time over an entire 8 or 12-hour shift.
• Must be able to climb ladders and stairs while wearing special gowning.
• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a cold, wet environment.
• Must be able to work multiple shifts, including weekends. Must be able to work overtime as required.
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.
• May require immunization before performing work within the manufacturing area.