Manufacturing Lead
Fremont, CA - USA
Job Summary
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment chemicals supplies and services essential in healthcare scientific research safety and education. As a global leader in serving the scientific community the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier cleaner and safer. Their global team delivers innovative technologies convenient procurement solutions and pharmaceutical services through industry-leading brands.
Summary:
Team Lead Operator role in Manufacturing acts as a working leader on the Filling manufacturing floor. Partners with Supervisors and Managers to maintain production flow develop team members and improve operational performance. Operates in a cGMP-regulated environment with responsibility for handling DEA-controlled substances (Schedules I V) in compliance with DEA and FDA regulations.
Responsibilities:
- Lead coach and motivate manufacturing operators to achieve production targets.
- Facilitate daily tier meetings and maintain accountability boards.
- Communicate production performance issues and team morale updates to leadership.
- Promote safety quality accountability and 4i values across the team.
- Train and develop operators through coaching and performance feedback.
- Execute manufacturing/testing activities for complex products in compliance with cGMP requirements.
- Ensure accurate documentation and address nonconformance issues.
- Collaborate with cross-functional teams to prioritize work and resolve operational challenges.
- Prepare materials for work orders and organize team assignments for daily operations.
- Review batch records and execute MRP transactions.
- Maintain documentation aligned with cGMP and Quality System standards.
- Support inventory management and material accuracy.
- Monitor employee performance and equipment productivity metrics.
- Participate in 5S and continuous improvement initiatives.
- Represent the department in meetings and communicate operational updates.
- Perform additional duties assigned by management.
- High school diploma or equivalent required and college degree is preferred.
- 4 to 6 years of manufacturing and leadership experience.
- Minimum 2 years in a lead trainer or coaching role.
- Strong leadership coaching and team-building abilities.
- Ability to build trust within a diverse workforce.
- Strong accountability and conflict management skills.
- Effective verbal and written communication skills.
- Ability to provide constructive feedback and recognition.
- Knowledge of cGMP Quality System Regulations ISO standards CAPA and nonconformance handling.
- Hands-on experience operating and troubleshooting manufacturing equipment.
- Experience with batch records SOPs and inventory transactions.
- Familiarity with MRP systems and electronic documentation systems.
- Proficiency in Microsoft Office (Word Excel PowerPoint).
- Ability to lift up to 40 lbs.
- Comfortable working in cold/freezer environments and around loud equipment.
- Ability to use PPE including lab coats gloves safety glasses steel-toed shoes and hearing protection.
- Must pass background check and controlled substance screening for DEA-controlled substance handling.