Manufacturing Team Lead

Manufacturing Team Lead

Business: Pharma Solutions Department: Operations (OPS) Location: Lexington

Job Overview

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.

Reporting Structure

This position reports to the Production Supervisor

Shift

Nights

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