Manager/Supervisor, Metrology
$115,600–$176,300 year
On-site · Rockville, Maryland, United States
Job Summary
Lead the calibration function and maintain the calibration program ensuring compliance with quality standards for cGMP and related regulations. Manage, mentor, and motivate staff for improved performance, while ensuring adequate training in cGMP, quality, and safety standards. Oversee the computerized maintenance database (BMRAM), coordinate calibration and preventive maintenance activities, and procure relevant instrumentation. Requires a solid understanding of industry standards, effective communication skills, and at least 4 years of related experience for Supervisor and 6 years for Manager, with appropriate educational qualifications.
Required Qualifications
- Bachelor’s in engineering, Life Sciences or related field or equivalent amount of experience
- 4 years of related experience
- 6 years of related experience for Manager role
- 1 year of direct supervisory experience
- Solid understanding of cGMP and metrology systems
- Strong knowledge of industry standards and guidelines, such as, ISO, ISPE Baseline Guides and CFR’s
- Scheduling and schedule tracking experience
- Effective oral and written communication skills
- Excellent problem solving skills
- Computer skills: MS Office Suite, BMRAM
Desired Qualifications
- Understanding and knowledge of Process Equipment and Clean Utility Systems used in Biopharmaceutical manufacturing
- Capable of effectively negotiating contracts, bids, and change orders with vendors or contractors for calibration services
- General knowledge of the instrumentation typically used in a Biopharmaceutical manufacturing plant
Additional Requirements
- Must work and interact effectively and professionally with others
- Willingness to work with a “hand-on” approach in managing the calibration function
- Ability to work in collaborative and independent work situations and environments with minimal supervision
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