Histology Process Lead; 2nd Shift

Position: Histology Process Lead (2nd Shift)
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The Position

Second

Shift: 2:00 PM - 10:30 PM

As the Histology Process Lead you will oversee the operational processes of the 2nd shift histology team to ensure workflow efficiency and support business goals. This role is responsible for delegating tasks to 2nd shift personnel while proactively collaborating with the 1st shift team and the 1st shift Process Lead. You will provide essential line support, ensure quality and training compliance, and assist the Histology Supervisor in meeting overall production schedules and customer service expectations.

The Opportunity

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

Who You Are

* You have an Associate's Degree

* You have 3 years Relevant work experience, preferably in GMP environment

* Experience leading teams or projects preferred.

Required

Skills and Qualifications

* Demonstrated experience with Lean / Continuous Improvement and previous experience with ERP systems and SAP

* Proficient with Google products (gMail, gSheets, gDoc, etc)

* High degree of initiative with the ability to work independently with minimal supervision

* Ability to read, write and comprehend English; strong communication skills (written and verbal)

* Strong organizational skills, planning skills, attention to detail, and excellent time management to manage multiple tasks and competing timelines

* Strong critical thinking, problem solving, analytical skills; ability to inspire and influence others; ability to…