Manufacturing Team Lead

Manufacturing Team Lead

Business: Pharma Solutions

Department: Operations (OPS)

Location: Lexington

Job Overview

Reporting to the Production Supervisor, the Manufacturing Team Lead serves the point person and on-the-floor resource for manufacturing operators, as well as performs all activities related to the preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production.

Shift: Days

Reporting Structure

This position reports to the Production Supervisor.

Key Responsibilities:

• Assists operators by accurately checking processes and tasks or setting-up, trouble-shooting and product change-overs

• Ensure housekeeping activities are completed, ensure cleanliness and orderliness of manufacturing area at all times

• Ensure correctness of team's manufacturing documentation

• Coordinate and provide on-the-job training to new hires

• Perform end-of-shift reports, as needed

• Performs line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, operation vial washing equipment

• Operate and maintain production related equipment

• Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities

• Execute validation protocols for processes and equipment

• Maintain records and a clean environment to comply with regulatory requirements

• Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.

• Assists operators by accurately checking processes and tasks or setting-up, trouble-shooting and product change-overs

• Monitor and may perform daily operations and provide direction to staff as needed to maintain safe and cGMP compliant work environment.

• Monitor batch production records and documentation entries throughout the manufacturing/packaging/inspection process to ensure timely closure.

• Helps to ensure compliance with all government and company regulatory requirements to ensure applications of cGMP compliance with respect to staff, areas, documentation, and quality requirements.

• Other duties as assigned

Qualifications:

• High School education or equivalent

• Minimum 2 years of experience in an aseptic, or other cGMP pharmaceutical manufacturing environment

• Ability to communicate effectively and lead a team

• Mechanical aptitude, ability to operate processing equipment

• Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA)

• Ability to read, interpret, and follow written instructions

• Team player committed to quality and working effectively with others

• Track record of consistent attendance and overall reliability