Manufacturing Team Leader, Fremont

Team Lead Operator

The Team Lead Operator is a working leader on the Filling manufacturing floor, partnering with the Supervisor and Manager to keep production running, develop people, and build a team where every operator can perform at their best. This role operates in a cGMP environment and includes handling DEA-controlled substances (Schedules IV) in strict accordance with DEA, FDA.Lead, coach, and motivate a diverse team of operators to meet daily production goals. Facilitate daily tier meetings and accountability boards, keeping Supervisors/Managers informed on performance, challenges, and team morale. Promote a culture of safety, quality, and accountability, consistently modeling and reinforcing 4i values.Support the development of operators through training, coaching, and performance feedback in partnership with leadership. Execute manufacturing and/or testing of complex products in compliance with cGMP, ensuring accurate and complete documentation while addressing nonconformance issues. Collaborate with cross-functional teams to prioritize work, resolve issues, and remove operational barriers.Ensure materials are prepared for work orders and that team members are effectively organized for daily execution. Review batch records, execute MRP transactions, and maintain documentation in alignment with cGMP and Quality System requirements. Support inventory management activities to maintain accuracy and availability of materials.Track and trend employee performance and equipment productivity, while identifying potential improvements. Engage in 5S and continuous improvement initiatives, collaborating across departments to enhance processes and procedures. Represent the department in required meetings and communicate key updates.Perform additional duties as assigned by department and/or Management. Standard shift is 6:00 AM to 2:45 PM, Monday through Friday. Leads must be flexible to support after-hours overtime, flexible to swing shift demand and occasional weekend overtime as production demand requires. Leadership MindsetYou take ownership without being asked, and you bring the team with you. You build trust across a diverse workforce and adapt your style to get the best out of each person. You can have direct conversations with respect, hold the line on standards, and give credit publicly. Experience 4-6 years in direct manufacturing and leadership experience with 2+ year in a lead, trainer, or coaching role.Working knowledge of cGMP, Quality System Regulations, and ISO, with comfort handling nonconformances and CAPAs. Hands-on experience operating and troubleshooting production equipment. Skills Clear communicator across operators, peers, and management. Strong attention to detail with batch records, SOPs, and inventory transactions.Comfortable using MRP systems, electronic document systems, and Microsoft Office (Word, Excel, PowerPoint). Education High school diploma or equivalent required. College Degree preferred. Physical and Work Environment Ability to lift up to 40 lbs without assistance. Work in compliance with all Good Manufacturing Practices (GMP) and safety standards, including exposure to cold room/freezer environments (as low as -20C) and loud equipment.Required use of Personal Protective Equipment (PPE), including lab coat, gloves, safety glasses, steel-toed shoes, and hearing protection. Responsible for handling and overseeing DEA-controlled substances (Schedules IV); must successfully complete a background check, including controlled substance screening.Employee Benefits: At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits: Four options of medical Insurance Dental and Vision Insurance 401k Contributions Critical Illness Insurance Voluntary Permanent Life Insurance Accident InsuranceOther Employee Perks About LanceSoft LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.