Histology Process Lead (2nd Shift)

About the role

Quality and Safety Maintains Right to Operate by ensuring all processes are performed safely; addresses and escalates hazards; timely reports incidents and near misses Maintains the quality system and achieves quality objectives Ensures audit readiness (OSHA, FAA, FDA, etc.) and represents team during internal audits/inspections Ensures accuracy and completeness of procedures for receipt, quarantine, storage, and disbursement of materials per FDA, OSHA, FAA, QSR, ISO, GMP, MEE, and Roche policies Coordinates training completion and execution (NCRs, OJT, Operating Procedures, Work Instructions); maintains >95% training compliance Ensures inventory accuracy and adherence to inventory control processes (TECO, Cycle counts, etc.) Assists with NCR investigations, reworks, corrective actions, and document changes including writing new or updating work instructions and OPs Production Monitors, balances, and delegates work to employees and contractors to achieve production goals and schedule adherence Provides 20-40% line support including receive, material handling, product build, formulation, material availability, SAP transactions, packet review, audits, and resource allocation Interfaces with complex systems and controls in a regulated manufacturing environment Ensures daily end-of-shift reports and pass downs are completed for proper communication between shifts and teams Effectively leads multiple production lines Coordinates maintenance and calibration of equipment in responsible areas Continuous Improvement Ensures adherence to 6S, cycle times, and standard work; identifies and implements process improvements Facilitates and/or participates in Tier Meetings and staff meetings Troubleshoots problems, engages support functions, and assists in implementing preventative measures Collects, populates, and trends daily metrics (Safety, Quality, Cost, Delivery) to identify gaps and support operational excellence Teamwork and Collaboration Proactively collaborates with peers across shifts and functions to achieve daily targets; provides performance feedback to leadership on employee contribution, attendance, and quality Ensures successful onboarding of new employees and contractors; participates in the interview process Performs other duties as assigned by management