Description

• Acts as a working supervisor for the component manufacturing department. Assures that activities are conducted in compliance with SOPs and regulatory guidelines.
• Assists with the development and implementation of effective corrective action plans in response to non-compliance, deviations, or operational problems.
• Interviews and recommends for hire component manufacturing staff. Assures that selected personnel have the necessary knowledge, skills, and abilities to meet the requirements of the job.
• Assists with internal staff problems and identified concerns. Assists with investigation and resolution of issues.
• Assists with the development of annual competency plans. Ensures that plans are appropriately implemented. Assists with the development of corrective action plans and implements, as necessary.
• Assists with the development and maintenance of department SOPs.
• Promptly investigates O reports, errors and accidents related to component manufacturing. Assists with the development of corrective action plans and implements, as necessary.
• Assists with the development and scheduling of product QC.
• Assists with the preparation and scheduling of periodic maintenance, calibration and validation of instruments and equipment.
• Participates in activities to further professional development.
• Other duties as required to fulfill the organization’s mission and vision.

Qualifications

Education: Associates degree or equivalent experience

Licensure/Certification: None; prefer MT or MLT

Experience: 4 years component processing or other equivalent cGMP regulated environment, plus

2 years supervisory responsibility

Medium Work - Walking and/or standing for extended periods of time with occasional sitting. Occasionally exerting between 20-60 lbs. of force to lift or move objects.