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Operation Supervisor, Packaging - 1st Shift
Operation Supervisor, Packaging - 1st ShiftStrides Pharma Inc • Spring Valley, NY, US
Operation Supervisor, Packaging - 1st Shift

Operation Supervisor, Packaging - 1st Shift

Strides Pharma Inc • Spring Valley, NY, US
30+ days ago
Job type
  • Full-time
Job description

Job Description

Job Description

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.
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    Supervisor 1St Shift • Spring Valley, NY, US

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