Work Schedule
First Shift (Days)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As a Team Leader, Manufacturing Operations at our Fremont, CA site within the Niche Diagnostics Division, you will supervise a team of approximately 10 Packaging Operators, including a Lead Operator, and report to the Manager, Manufacturing Operations.
This is a direct people supervisory role where you will be responsible for day-to-day team leadership, including work assignments, coaching, attendance, timecards, PTO, performance reviews, and corrective actions when necessary. You will be accountable for your team's performance in Safety, Quality, Delivery, and Productivity.
This is a hands-on, working leadership role. In addition to supervising the team, you will regularly perform packaging operations alongside employees and provide production coverage as needed. You will also support other Manufacturing Services teams, including Filling, Packaging, and Label Printing, based on business needs or as assigned by the manager.
The position is primarily day shift (approximately 6:00 AM to 2:45 PM), with flexibility for schedule changes and overtime based on production needs. This role requires working as an authorized user handling DEA-controlled substances (Schedules I–V) in a cGMP-regulated diagnostic kit manufacturing environment.
What You Will Do
Team Leadership & Supervision
Supervise direct reports, conduct 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 while maintaining accurate training records and an updated skills matrix.
Manufacturing Operations
Assign daily work across packaging lines, label application, and kitting operations to meet production schedules.
Work alongside the team performing packaging, kitting, and labeling operations 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.
Quality, Compliance & Continuous Improvement
Ensure manufacturing activities comply with cGMP, Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and applicable safety requirements.
Review batch records and logbooks for completeness and GDP compliance before submission to QA/QC and follow up on necessary corrections.
Initiate nonconformances, support deviations and root cause investigations, and complete assigned Corrective and Preventive Actions (CAPAs) on time.
Lead or participate in Practical Process Improvement (PPI), Lean, and 5S activities to reduce waste, improve efficiency, and minimize errors.
Perform other duties as required.
Required Qualifications
High School Diploma or GED required; Associate's or Bachelor's degree preferred.
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.
5+ years of manufacturing experience in a regulated environment (FDA, cGMP, ISO 13485, or similar).
Hands-on experience with nonconformances, deviations, or CAPAs, such as initiating nonconformances, supporting…