Operation Supervisor, Packaging - 1st Shift

Job Summary

The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 1st shift operations, 7:00am to 3:30pm. This role ensures that all production operations comply with cGMP, safety standards, and production schedules. The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.

Oversees and coordinates Manufacturing and Packaging operations.

Responsibilities

• Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).
• Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.
• Ensure timely execution of production schedules.
• Monitors manufacturing and packaging processes to ensure schedule is met within standards.
• Review and complete shift documentation, including batch documentation, logbooks, etc.
• Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift
• Support investigations for deviations that occur during the shift. Assist in determining and implementing CAPA.
• Provide training, guidance, and performance feedback for shift employees. Ensure training requirements are met. Support employee development and cross-training.
• Executes procedures to complete tasks in a compliant and safe manner.

Continuous Improvement

• Captures and reports metrics; troubleshoots downtime to increase operational efficiency.
• Lead or participate in Continuous Improvement projects.
• Troubleshoots and resolves process issues.

Issues & Deviations

• Performs defect evaluations and initiates production events.
• Identifies, reports, and suggests resolutions for processing related issues.
• Assists in the investigation of unplanned deviations.

Teamwork and collaboration

• Provides priorities for the off-shift operations, focusing resources on priority products.
• Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.

Continuous Training

• Ensures personnel are current with training requirements.
• Stays current on SOPs and cGMPs.

Continuous Safety & Compliance

• Contribute to safety audits.
• Ensures out manufacturing/packaging activities safely, as required, on a daily basis.
• Follows all safety and compliance procedures and participates in required training.
• Adheres to all cGMP compliance/regulatory mandates and quality requirements.
• Participate in safety teams, start-up discussions, incident debriefs, etc.
• Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.

Misc

• Other related duties as assigned to meet departmental and Company objectives.

Education & Experience

• Bachelor’s degree in Pharmacy, Chemistry, Engineering, or a related discipline preferred; relevant experience my substitute.
• Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging.

Knowledge

• Thorough knowledge of cGMP and FDA regulations.
• Thorough knowledge of manufacturing and packaging operations.

Skills & Abilities

• Demonstrated leadership, communication, and decision-making skills.
• Ability to oversee and manage the daily operations of manufacturing and packaging.
• Ability to monitors processes to ensure schedule is met within standards.
• Ability to analyze metrics and troubleshoot downtime.
• Effectively interfaces with Quality Assurance to inform of deviations or other line issues.
• Demonstrates the ability to work in collaboration with others as a part of a team.
• Ability to lead in Continuous Improvement projects.
• Posses technical writing skills.