Manufacturing Group Leader V (Monday-Friday:Third Shift)

Filling

Maintains production area to prevent cross-contamination (line clearance).

Assigns tasks for manufacturing operations and support associates.

Captures turnaround, set-up, and changeover of manufacturing equipment.

Verifies component readiness, reject verification, and product returns.

Provides feedback to Team Leaders regarding associate performance and behaviors.

Ensures that manufacturing equipment is operating efficiently at or above target line speeds while minimizing line downtime and product reject.

Responsible for maintaining OEE (system entry and standards).

Completes all batch record and inventory documentation accurately (review batch records/ERPLx transactions).

Aids in nonconformance investigations, material variance review, line efficiency standards, and improvement opportunities.

Liaison with MQA Quality Control and QC Microbiology EMPS departments.

Backup for MQA Quality Control.

Maintains all required training during the year (SOP, EHS, and HR).

Supports operational excellence and EHS initiatives.

Assumes responsibility for the GMP, ISO, EHS awareness and compliance within the respective area.

Attends and participates in OpEx improvement initiatives such as reducing costs and OEE improvements.

Packaging

Operates packaging line and serialization equipment.

Performs Systech serialization and ERPLx report generation.

Filling

Operates ointment, gel, solutions, and suspension filling lines including RABS fillers.

Operates Continuous Particle Monitoring System (Filling)

Performs Gatekeeper, CPMS, ERPLx, and Aseptic Filler report generation and review.