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GENERAL SUMMARY OF POSITION:

The Metrology Operations Manager II is responsible for managing the work of the Metrology group across multiple sites to ensure that the instrumentation is calibrated in compliance with current Good Manufacturing Practices (cGMP)/current Good Laboratory Practices (cGLP) and industry standards.  Performs both hands-on calibration and supervisory functions.  The individual is responsible for delivering FDA compliance and excellent customer service in a 24-hour manufacturing environment within a prescribed budget.  This is a performance based position where success is measured through the achievement of organizational and departmental goals.

MAJOR RESPONSIBILITIES:

Manages metrology program for FDA licensed manufacturing facility and associated research and development operations.  This includes:

• Calibration, troubleshooting and repair of a variety of complex analytical instruments.
• Development of calibration methods.
• Generation, review and revision of calibration SOPs.
• Scheduling and documentation of calibration activities through a computerized maintenance management system (CMMS).
• Ensures standardization of metrology procedures across multiple sites.
• Develops and maintain management metrics for metrology program.
• Develops training programs for metrology personnel. Provides specialized training for specific tasks / equipment as needed.
• Specifies and procures metrology related tools, standards, instruments and equipment.
• Adheres to budgets, schedules and performance requirements.
• Negotiates and manages multiple contracts with outside vendors performing calibrations on various types of equipment.
• Maintains calibration records, instrument identification and tagging.
• Writes and implements change controls to maintain cGMP compliance.
• Writes incident/deviation reports as necessary, performing root cause analyses and identifying corrective actions as appropriate.
• Manages employee performance and provide coaching and mentoring of direct reports .
• Serve as technical advisor on instrumentation issues.
• Performs additional job related duties as required.

REQUIRED QUALIFICATIONS:

• BS degree preferably in a scientific discipline or equivalent
• Minimum of 5-7 years relevant experience including management experience
• Executes assignments with minimal supervision/direction. Capable of concurrently executing and managing a variety of projects. Demonstrated excellent time management and organization skills
• Exercises judgment within defined procedures and policies to determine appropriate action
• Demonstrated capability to manage others, assign and schedule work, and conduct performance evaluation
• Knowledgeable of pharmaceutical/biotechnology process instruments, equipment, and related facility unit operations. Well-versed in current Good Manufacturing Practices.
• Demonstrated excellent communication skills, both written and verbal, as well as ability to communicate with individuals in all levels of the organization
• Experience in all aspects of Calibration/Metrology processes. Requires a thorough understanding of metrology principles defined in ASNI/NCSL
• May require frequent travel between the JP and Mattapan campuses
• Ability to ensure 24-hour operations which may dictate irregular work schedules based on business needs
• Ability to lift fifty (50) pounds with proper lifting technique.