Jobs · Management · California

Lead Operator Manufacturing

TekWissen ® · Fremont, CA · 2 mo ago
On-siteManagement$24–$29/hrContract

TekWissen is a global workforce management provider offering strategic talent solutions to clients worldwide. This opportunity is with a leading biotechnology product development services client that supplies laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. The organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer.

About the role

As a Manufacturing Lead, you will act as a working leader on the Filling manufacturing floor in a cGMP-regulated environment. You will partner with Supervisors and Managers to maintain production flow, develop team members, and improve operational performance while 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.

Requirements

  • High school diploma or equivalent required; college degree 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.

Pay

$24 to $29 per hour

Schedule

  • Monday to Friday, 06:00 AM to 02:45 PM.
  • Flexible to occasional swing shift.

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