Process Lead Manufacturing

The Position

Summary :

A Process Lead is responsible for overseeing the operational processes of an organization to support business goals. A Process Lead evaluates the efficiency of workflow procedures, identifying inconsistencies, and revising processing techniques as needed to improve deliverables, maximize productivity to achieve business goals.

They are responsible for training new employees, sharing best practices, and ensuring team members are qualified to perform the work.

A Process Lead motivates and provides guidance to team members, cultivates and reinforces appropriate group values, norms, and behaviors, guided by Roche operating principles.

A Process Lead must have excellent communication and organizational skills and identify opportunities that would drive the business forward.

Responsibilities : Quality and Safety

Quality and Safety

Maintain Right to Operate and ensure that all processes are performed in a safe and healthy manner; Address and escalate any potentially unsafe hazards;

Timely reporting and investigations of safety hazards, incidents and near misses.

Maintain the quality system and achieve our quality objectives.

Audit readiness (OSHA, FAA, FDA, etc.); Represent team during internal audits / inspections.

Ensure accuracy and completeness of all procedures and instructions related to the proper receipt, quarantine, storage, and disbursement of materials as it relates to FDA, OSHA, FAA, QSR, ISO, Good Manufacturing Practices, manufacturing exception events (MEEs) and other Roche policies and procedures.

Coordinate, facilitate and provide the time for team members to complete and execute training NCRs, OJT, Operating Procedures, Manufacturing Work Instructions);

Responsible for maintaining greater than 95% in training compliance.

Inventory accuracy and adherence to inventory control processes (TECO, Cycle counts, etc).

Assists with NCR investigations, reworks and corrective actions.

Monitor, review and initiate document changes, including writing new or updating existing work instructions and OPs impacting areas of responsibility;

Collaborate with other functions as necessary

Production

Monitor, balance, delegate and provide detailed direction to employees and contractors in order to achieve production goals and adherence to the production schedule.

20% to 40% line support to include but not limited to : Receive, material handle, build product / materials, formulate bulk solutions, facilitate material availability, SAP transactions / confirmations and packet review, audit processes, allocate resources and protocol / validations.

Interfaces with highly complex systems and controls in a regulated manufacturing environment.

Ensures that daily end of shift reports / pass downs are completed to ensure proper communication and synergies between shifts and teams.

Ability to lead more than one production line.

Coordinate the maintenance / calibration of equipment in their responsible areas.

Continuous Improvement

Ensure adherence to 6S, cycle times and standard work; Identifies and implements process improvements and continuous improvement initiatives.

Facilitate and / or participate in Tier Meetings and staff meeting

Troubleshoots problems, engages appropriate support functions and assists in implementing preventative measures.

Collect data, populate and trend daily metrics Safety, Quality, Cost, Delivery) to identify gaps and support operational excellence initiatives and improvements.

Teamwork and Collaboration

Proactively collaborate with peers in other shifts / functions to ensure daily targets are achieved.

Provide feedback to the Leader on employee performance (contribution, attendance, quality, etc.) for performance management purposes.

Ensure successful onboarding of new employees and contractors.

Participate in the interview process.

Other duties as assigned.

Education / Experience :

Associates Degree

3 years relevant work experience, preferably in GMP environment

Prefer previous experience leading teams or projects

Equivalent education and experience will be considered

Knowledge Skills and Abilities :

Demonstrated experience with Lean / Continuous Improvement

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

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

Previous experience with ERP systems; SAP preferred

Ability to read, write and comprehend English

Ability to work with cross-functional teams

Ability to be punctual, work quickly and accurately in a high-volume environment with constant change

Ability to inspire and influence others

Ability to give and receive feedback in a coaching manner

Strong organizational skills, planning skills and attention to detail

Strong communication skills - written, verbal

Strong critical thinking, problem solving and analytical skills

Excellent time management skills to manage multiple tasks and competing timelines

Relocation assistance is not available for this opportunity.