General Summary

The Supervisor Operations 3rd Shift (Mon-Fri, 11:00 PM - 7:15 AM) is responsible for the departmental activities to ensure achievement of USL's high standards for quality; and compliance with regulatory requirements; and that company and departmental objectives are met. The Supervisor Operations provides direct oversight and leadership to employees in the manufacturing and/or packaging functions and collaborates with department leadership to develop and implement functional goals and objectives aligned with the Corporate Objectives.

Essential Duties

• Provide oversight and direction for Manufacturing and/or Packaging activities.
• Oversees shift personnel to ensure compliance with Company policies, safety regulations, SOP's and GMP's.
• Ensure the Manufacturing and/or Packaging schedule is met.
• Ensure Manufacturing and Packaging employees are using appropriate GMP's, SOP's, Safety and Quality standards.
• Ensure written logs and records are maintained as required by cGMP and SOP's.
• Ensure change control procedures are followed; write and submit change control requests for new/modified processes and equipment.
• Develop new SOP's and update existing SOP's as required to ensure compliance with cGMP and quality standards.
• Promote a safe work environment.
• Be familiar with Material Safety Data Sheets (MSDS) on area chemicals and ensure employee familiarity of MSDS use.
• Ensure that qualified operators are performing job duties.
• Work with scheduling to ensure there is time to get needed training completed.
• Manage training compliance for all employees on designated shift.
• Responsible for performance management of staff on designated shift (e.g., performance feedback and coaching, disciplinary action).Maintain appropriate staff levels on designated shift.
• Communicate cross-functionally and develop relationships to ensure Maintenance, Tech Services, and Engineering projects and activities are completed.
• Create, maintain, monitor, and communicate metrics.

Education and Experience

High school degree or equivalent with 6 years' experience (3 years supervisory or leadership experience) in a manufacturing/packaging environment.

Bachelor's degree preferred. With a Bachelor's degree, 2 years' experience (1 year supervisor or leadership experience) in a manufacturing/packaging environment required. Experience working with automated packaging and manufacturing equipment strongly preferred.  Prior knowledge of cGMP's, regulatory and safety requirements in a manufacturing environment. Working knowledge of MS office products. SAP knowledge desired.

Physical Requirements

Listening: 67 - 100% (Constant). Speaking: 67 - 100% (Constant). Near acuity (vision): 67 - 100% (Constant). Standing (Moving About): 67 - 100% (Constant). Use of computer keyboard / mouse: 1 - 33% (Occasional). Lift / Carry - Waist or Lower (50 to 75 lbs.): 1 - 33% (Occasional). Push / Pull (over 100 lbs.): 1 - 33% (Occasional). Lift / Carry - Waist or Lower (25 lbs. or less): 34 - 66% (Frequent). Push / Pull (25 lbs. or less): 34 - 66% (Frequent). Work in excess of 40 hours per week: 1 - 33% (Occasional). Sitting: 1 - 33% (Occasional).

Mental and Motor Requirements Reading / Comprehension: 67 - 100% (Constant). Writing / Composition: 67 - 100% (Constant). Interaction with others using professionalism and tact: 67 - 100% (Constant). Problem Solving: 67 - 100% (Constant). Verbal communication: 67 - 100% (Constant). Independent decision making: 67 - 100% (Constant). Basic math calculations: 1 - 33% (Occasional). Ability to prioritize tasks: 34 - 66% (Frequent). Demonstrated ability to follow written procedures: 34 - 66% (Frequent). Ability to manage changing priorities: 34 - 66% (Frequent). Computer Skills: 34 - 66% (Frequent).

Environmental Requirements Team work: 34 - 66% (Frequent). Independent Work: 34 - 66% (Frequent). Exposure to Loud Noises: 34 - 66% (Frequent). Exposure to fumes / odors: 34 - 66% (Frequent). Exposure to dust: 34 - 66% (Frequent). Exposure to automated machinery: 34 - 66% (Frequent). Works in Manufacturing Environment: 67 - 100% (Constant). General office environment: 1 - 33% (Occasional). Exposure to active pharmaceutical ingredient: 34 - 66% (Frequent). Required to wear a respirator when exposed to fumes or dust: 34 - 66% (Frequent). Required to wear safety glasses and other PPE: 67 - 100% (Constant).

Other Knowledge, Skills, and Abilities Knowledge of cGMP's, rules and regulations of OSHA, FDA, DEA and employment practices. Strong organizational, interpersonal, and leadership skills, verbal and written communication, ability to motivate and give clear direction.

Upsher-Smith Laboratories, LLC is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Upsher-Smith Laboratories, LLC will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.