We are actively seeking a Packaging Supervisor to join our growing team. The incumbent will be responsible for supervising packaging personnel and processes in a temperature/humidity controlled cGMP environment. Accountable for achieving production targets while maintaining cost controls. Supervises and coordinates activities of packaging workers to ensure that products meet standards and processes are conducted in compliance with Federal, State, and local requirements by performing the following duties. Supervises packaging operation and work to meet production/project goals. Maintains floor visibility to drive Right First Time (reduce human error) and is available to discuss and address issues and concerns.
Roles and Responsibilities:
- Develops and maintains common expectations for technical and behavioral performance of operators.
- Initiates or suggests plans to create a motivating work environment to achieve departmental goals.
- Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA.
- Complies with all company and site policies and Manufactures products by supervising staff; organizing and monitoring work flow.
- Understands and responsibly performs duties and supervises employees with attention to quality, safety and environmental matters. Items include; wearing appropriate personal protective equipment, recognizing, reporting and appropriately responding to hazards in the work area (spills/accidents/near misses), maintaining proper housekeeping at all times, properly labeling and storing chemicals, plus all other relevant job requirements.
- Ensure deviations and non-conformances are investigated adequately and action taken appropriately. Initiate and drive to closure assigned corrective actions and preventive actions (CAPAs).
- Ensure the necessary in process checks are in place to ensure quality of products. To maintain the overall cGMP of the production area and to coordinate with other functions/Departments for execution of batches.
- Enforces and interprets company policies for operators, and ensures compliance with standard operating procedures, including issues related to safety and the environment. Ensure compliance to cGDP.
- Participates in design of quality processes and creation/modification/approval of Standard Operating Procedures (SOP’s) and Work Instructions (WI’s) and training aids.
- Develops and modify as needed OJT programs for workforce. Provides support to Consumer Complaint investigations.
- BS/BA Degree in Science Preferred or Equivalent Experience
- 3-5 years packaging experience or 3 years supervisory experience preferred.
- Work experience in pharmaceutical industry.
- Proven ability to develop people.
- Experience in developing and executing tactical plans
- Ability to drive action.
- Analytical software proficiency to support metric development.
- Technical knowledge of supply chain process.
- Technical writing ability.
- Ability to gather information, analyze it and develop tactical plan.
- Acts decisively, setting clear priorities.
- Demonstrated leadership and influencing skills.
- Drives accountability.
- Must have the ability to comprehend packaging/manufacturing processes and equipment.
- Must have good verbal and written skills, and proven analytical ability.
- Strong organizational, oral and written communication skills
- Successfully completes regulatory and job training requirements on time (cGMP, ISO14001, OSHA, DEA, etc.). Writes procedures and reviews batch records.
- Contributes to the CAPA process. Drives the deviation processes to completion, including determining root cause, writing the deviations, driving improvements, etc
- Maintains safe and clean work environment by educating and directing personnel on the use of all control points, equipment, and resources; maintaining compliance with established policies and procedures.
- Ensures that manufacturing data are entered into systems in a timely manner for production, regulatory, and financial accounting with the use of SAP ERP system.
- Drives production schedule attainment without compromising Right First Time.