Lead Manufacturing Technician (2nd shift)
About The Position
The Lead Manufacturing Technician, based in San Clemente, CA, will be responsible for the completion of scheduled production and management of preventative maintenance. The Lead will ensure proper documentation (cGMP and GDP), open/close jobs in the MRP system, and provide feedback and updates to Management and Engineering. This position will also prepare components, build assemblies, and bulk drug formulations. All activities will be performed with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality system regulation (QSR) medical device good manufacturing practices (GMP) requirements. Additional tasks include performing filing, capping, and crimping operations, packaging and labeling operations, sampling, visual inspections, and documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR). The role also involves tracking clean room, environmental chambers, and equipment preventive maintenance (PMs).
Requirements
- 8 – 10 years’ experience with high school diploma
- 6 – 8 years’ experience with associate degree in science or engineering
- 4 - 6 years’ experience with bachelor’s degree in science or engineering
- Experience working in and maintaining a clean room in accordance with GDP, cGMPs, and QSR standards
Responsibilities
- Completion of scheduled production
- Management of preventative maintenance
- Ensure proper documentation (cGMP and GDP)
- Open/close jobs in MRP system
- Provide feedback and updates to Management and Engineering
- Prepare components, build assemblies, and bulk drug formulations
- Perform filing, capping, and crimping operations
- Perform packaging and labeling operations
- Perform sampling
- Perform visual inspections
- Documentation and data input into MRP, Batch Records (BRs), and Device History Record (DHR)
- Track clean room, environmental chambers, and equipment preventive maintenance (PMs)
- Manage the operation schedule, project schedule, and adjusts the schedule and resources accordingly
- Supervise production technician(s) to optimize quality and output
- Perform all activities outlined for a Manufacturing Technician as needed
- Verify all documentation is followed and completed accurately (cGMP, QSR, and GDP)
- Manage Oracle to open and close jobs
- Manage inventory requests and reconciliation for accuracy
- Revise documentation to ensure accuracy and compliance
- Communicate feedback to engineering on Non-Standard Build Requests, Validation builds, Clinical builds, etc.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
