Plant Supervisor - Boston, Massachusetts
The Production Supervisor supervises all manufacturing tasks required for the safe production of active pharmaceutical ingredients in compliance with FDA, DEA, OSHA Federal, State, and Local regulations. The primary objective of this position is to ensure that all manufacturing operations are conducted in a safe manner and in compliance with all applicable cGMPs' and DEA requirements. Working flexibly across a broad range of chemical operations and participation on self-managed work teams is required. Training for and participation on Emergency Response teams is required. Availability for overtime and shift work (including rotating shifts and seven-day operation) is also required.
PRINCIPAL ACCOUNTABILITIES:
Compliance Tasks:
-Work with chemical technicians to develop safe work practices and improve their technical skills
-Responsible for safety, health, environmental and regulatory compliance for the shift team.
-Responsible for the correct execution of all batch records and adherence to all operating procedures.
-Enter GNOE’s and prepare investigations and CAPA’s for all shift deviations.
-Ensure that all reporting requirements have been fulfilled and provide necessary follow up.
-Audit manufacturing SOP’s for compliance.
-Perform the role of DEA coordinator. This requires witnessing all movement of controlled materials.
-Attend all required cGMP, DEA and ESHA training.
Supervisory Tasks:
-Prepare Performance Partnership Appraisal Process and quarterly updates for all direct reports.
-Prepare Individual Development Plans and quarterly updates for all direct reports.
-Track assigned employees on job performance metrics.
-Approve time cards for all direct reports.
-Provide coaching, counseling and discipline for all direct reports along with required documentation.
-Complete performance documentation forms for all direct reports.
-Develop self managed work team system within the manufacturing department.
-In conjuction with department management and HR, develop, deliver and monitor employee performance improvement plans as required.
Production Tasks:
-Oversee Daily Log and and daily intershift communication meetings.
-Manage all material writeoffs in SAP to ensure that we maintain near- real time inventory.
-Oversee all line and confined space entry processes.
-Coordinate and prioritize maintenance activities.
-Prepare and revise manufacturing batch records and SOP’s as required.
-Provide training to chemical technicians on production batch records and SOPs'.
-Provide direction to shift teams where necessary to ensure that scheduled operations are executed to plan.
-Revise and/or develop and implement manufacturing work practice systems in order to improve efficiencies.
-Prepare daily and weekly summary reports for the production manager.
Educational Requirements
BS degree in Chemical Engineering or Chemistry.
Required Experience & Technical Requirements
Related work experience in manufacturing or engineering in a chemical or pharmaceutical environment is preferred.
Primary Skills: API or Batch Chemical manufacturing experience
Salary: Between 70,000 - 90,000
Experience Required: 2.5 years minimum
Clearance Level Indicated: Clearable
Travel: 0 %
Additional Details: Chemical Engineer Degree STRONGLY DESIRED, Degree in Chemistry will be considered.
Contact name: Catherine Stier
Job reference code:
Email: cstier@germerintl.com
Website: www.germerintl.com