Lead Manufacturing Technician (2nd shift)

The Lead Manufacturing Technician, based in San Clemente, CA will be responsible for the completion of the scheduled production and management of preventative maintenance. The Lead will ensure proper documentation (cGMP and GDP), open/close jobs in 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.

How will you make an impact?

The Lead Manufacturing Technician, based in San Clemente, CA will be responsible for the completion of the scheduled production and management of preventative maintenance. The Lead will ensure proper documentation (cGMP and GDP), open/close jobs in 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 will include performing the following:

• Filing, capping, and crimping operations

• Packaging and labeling operations

• Sampling

• Visual inspections

• Documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR)

• Track clean room, environmental chambers, and equipment preventive maintenance (PMs)

What will you do?

• Manage the operation schedule, project schedule, and adjusts the schedule and resources accordingly

• Supervise production technician(s) to optimize quality and output

• Ability to perform all activities outlined for a Manufacturing Technician as needed

• Verify all documentation is followed and completed accurately (cGMP, QSR, and GDP)

• Manages Oracle to open and close jobs

• Manages 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.

How will you get here?

To be successful in this role, you will need to have the following:

• Industry (medical device, pharmaceutical, and/or biotechnology) and educational experience.

• 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

• It is highly desirable to have experience working in and maintaining a clean room in accordance with GDP, cGMPs, and QSR standards.

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