Supervisor Metrology

About Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world‑class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world.

Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much‑needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

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. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential 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…