Team Leader, Manufacturing Operations (Packaging)
About The Position
The Team Leader, Manufacturing Operations supervises approximately 10 Packaging Operators, including a Lead Operator, at the Fremont, California site within the Niche Diagnostics Division. The role reports to the Manager, Manufacturing Operations and is a direct people-supervisory position. The Team Leader manages work assignments, coaching, attendance, timecards, PTO, performance reviews, and corrective actions, and is accountable for the team's performance in safety, quality, delivery, and productivity. This is a hands-on working leadership role. The Team Leader performs packaging operations alongside employees and provides production coverage as needed. The position also supports Filling, Packaging, and Label Printing teams based on business needs or as assigned by the manager. The schedule is primarily first shift, approximately 6:00 a.m. to 2:45 p.m., with flexibility for schedule changes and overtime based on production needs. The role requires authorized handling of DEA-controlled substances (Schedules I–V) in a cGMP-regulated diagnostic kit manufacturing environment.
Requirements
- High school diploma or GED.
- At least 2 years of experience supervising direct reports, including assigning work, approving timecards, completing performance reviews, and addressing performance or attendance issues; lead experience without direct reports does not meet this requirement.
- At least 5 years of manufacturing experience in a regulated environment, such as FDA, cGMP, or ISO 13485.
- Hands-on experience with nonconformances, deviations, or CAPAs, such as initiating nonconformances, supporting root cause investigations, or completing corrective actions.
- Flexibility to work overtime and accommodate schedule changes based on production needs.
- Willingness to support other teams within Manufacturing Services as needed or as assigned by the manager.
- Working knowledge of cGMP, GDP, FDA quality system requirements (21 CFR Part 820), and ISO 13485.
- Demonstrated ability to coach and develop employees, provide direct feedback, and handle difficult conversations fairly and consistently.
- Strong communication skills with operators, peers, and cross-functional support teams.
- Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
- Ability to stand and walk for extended periods, lift up to 40 pounds without assistance, work in cold environments, and wear required PPE, including a lab coat, gloves, safety glasses, and hearing protection.
- Ability to successfully complete applicable background screening, including screening related to controlled substances.
Nice To Haves
- Associate's or bachelor's degree.
- Experience in packaging, kitting, or labeling operations within diagnostics, pharmaceutical, medical device, or another cGMP-regulated industry.
- Experience with QAD, Agile, Workday, or similar ERP, document control, and HR systems.
- Lean Six Sigma certification (Yellow Belt or higher) or experience with Lean, 5S, and structured problem-solving tools.
- Experience handling DEA-controlled substances.
Responsibilities
- Supervise direct reports, hold regular one-on-one meetings, provide timely feedback, complete performance reviews, and address performance, attendance, or conduct issues with HR support.
- Lead daily Tier 1 meetings to review safety, quality, delivery, and productivity metrics and establish daily priorities.
- Approve timecards and PTO requests, monitor attendance, and coordinate staffing coverage to maintain production schedules.
- Train and cross-train operators, maintain accurate training records, and keep the skills matrix updated.
- Assign daily work across packaging lines, label application, and kitting operations to meet production schedules.
- Perform packaging, kitting, and labeling operations alongside the team and provide production coverage as needed.
- Verify that materials, components, and required documentation are available before each scheduled work order.
- Collaborate with Planning, Engineering, EHS, QA, and QC to resolve equipment, process, and documentation issues.
- Support other Manufacturing Services teams as needed or as assigned by the manager.
- Ensure manufacturing activities comply with cGMP, SOPs, GDP, and applicable safety requirements.
- Review batch records and logbooks for completeness and GDP compliance before submission to QA/QC, and follow up on required corrections.
- Initiate nonconformances, support deviations and root cause investigations, and complete assigned CAPAs on time.
- Lead or participate in PPI, Lean, and 5S activities to reduce waste, improve efficiency, and minimize errors.
- Perform other duties as required.
Benefits
- Choice of national medical and dental plans and a national vision plan, including health incentive programs.
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
- At least 120 hours of paid time off (PTO).
- 10 paid holidays annually.
- Paid parental leave: 3 weeks for bonding and 8 weeks for caregiver leave.
- Accident and life insurance.
- Short- and long-term disability in accordance with company policy.
- Competitive 401(k) U.S. retirement savings plan.
- Employees’ Stock Purchase Plan (ESPP), offering eligible colleagues the opportunity to purchase company stock at a discount.
- May be eligible for a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
High school or GED
