Lead Operator, Manufacturing
Location: Fremont, CA Niche Diagnostics Division (NDX)
Standard Shift: 6:00 AM 2:45 PM, Monday through Friday, flexible to occasional swing shift
About the Role
The 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 I V) in strict accordance with DEA, FDA
What You'll Do
" 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 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.
Schedule and Flexibility
" 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.
What You Bring
Leadership Mindset
" You 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
" 3-4 years in direct manufacturing and leadership experience with 1+ 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 -20 C) 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 I V); must successfully complete a background check, including controlled substance screening.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.