Supervisor Metrology

Job Summary

Supervises Metrology group, which is comprised of personnel responsible for laboratory instrument qualification, maintenance and calibration, as well as manufacturing/packaging equipment calibration. Ensures laboratory instrumentation is appropriately identified, qualified, calibrated and maintained and manufacturing and packaging equipment is properly calibrated. Provides technical support for purchasing and maintaining instrumentation/equipment. Ensures final review of calibration/maintenance documents is appropriate. Provides leadership and technical expertise in response to problems (e.g. instrument investigations and CAPAs). Ensures the calibration program is operated under cGMP's and that the Metrology team operates in compliance with safety program. Provides input on the department budget. Ensures the team operates in a safe manner, and all personnel are properly trained on compliance and safety.

Essential Job Functions

• Provides leadership to the Metrology team. Ensures the group has the education, training and experience necessary to perform assigned functions (i.e. interviews and recommends staff, provides work direction and guidance, coaches and develops personnel).
• Demonstrates mentoring skills. Manages personnel development and behavior to ensure a professional environment. Reviews personal development areas with direct reports.
• Demonstrates cooperation and professionalism with all members of the Bora organization. Maintain strong communication skills within the company by addressing issues properly. Display strong critical thinking skills.
• Demonstrates strong written and verbal communication skills. Participates in departmental, interdepartmental and industry meetings as necessary. Demonstrate networking skills throughout the company and industry.
• Functions as a subject matter expert for instrumentation and cGMP compliance as applicable. Demonstrate an understanding of applicable regulations and guidance (e.g. USP, DEA, EPA, OSHA, and FDA).
• Provides information to the team to aid in the planning of instrument/equipment, maintenance and calibration activities to support the equipment end users.
• Aids in developing, implementing, and monitoring appropriate procedures and controls (e.g. SOP's, Work Instructions, and instrument/equipment calibration requirements). Evaluate procedures to ensure cGMP compliance.
• Highlights misuse of instrumentation/equipment to the appropriate department management.
• Conducts the final review of calibration data and instrument qualifications as necessary.
• Responsible for communicating instrument/equipment out of calibration results to Quality and senior management. Conducts deviation investigations on out of specification results for calibrations.
• Communicates with outside vendors/ calibration laboratories as appropriate. Ensures the coordination and review of the calibration results from 3rd party testing laboratories are appropriate.
• Evaluate Metrology systems and processes. Implement process changes for efficiency improvements and cost savings. Ensure efficiencies are built into the technician's day-to-day tasks. Continue to increase their productivity, while maintaining error-free work.
• Participate in the FDA, customer and internal audits. Develop and implement deficiency responses to the audits.
• Review and provide input for the departmental budget. Approve expenditures as necessary. Conducts internal and external audits as necessary.
• Review Pharm Forum and USP as necessary. Ensure procedures are updated accordingly. Respond to the USP as necessary.

Minimum Education, Experience, & Skills

Bachelor Degree or master's degree in chemistry, Engineering or related science field with 12 credits of college chemistry, preferably with courses in analytical instrumentation.

• Bachelor's degree with a minimum of 5 years' experience, preferably in the pharmaceutical industry OR a master's degree a minimum of 3 years' experience, preferably in the pharmaceutical industry.
• Analytical chemistry knowledge.
• Experience working in a laboratory environment, preferably in the pharmaceutical industry.
• Leadership experience preferred.
• Experience with metrology preferred.