Supervisor Metrology

Bora Pharmaceuticals•Maple Grove, MN

1d•$88,000 - $115,000

About The Position

The Supervisor Metrology leads the Metrology group responsible for laboratory instrument qualification, maintenance, and calibration, as well as calibration of manufacturing and packaging equipment. The role ensures laboratory instruments are identified, qualified, calibrated, and maintained, and that manufacturing and packaging equipment is properly calibrated. It provides technical support for purchasing and maintaining instrumentation and equipment, reviews calibration and maintenance documentation, and leads technical responses to issues such as instrument investigations and CAPAs. The supervisor ensures the calibration program operates under cGMP requirements and that the team complies with safety requirements, receives appropriate training, and works safely. The position also contributes to departmental budgeting. The supervisor leads, coaches, and develops team members; supports planning for maintenance and calibration; develops and monitors procedures and controls; reviews calibration data and instrument qualifications; and communicates out-of-calibration results to Quality and senior management. The role coordinates with outside vendors and calibration laboratories, evaluates systems and processes for efficiency and cost improvements, and participates in FDA, customer, and internal audits, including developing responses to audit deficiencies. It also reviews relevant Pharm Forum and USP materials and ensures procedures are updated as needed.

Requirements

Bachelor’s or master’s degree in chemistry, engineering, or a related science field, with 12 college chemistry credits; courses in analytical instrumentation are preferred.
With a bachelor’s degree, at least 5 years of experience; with a master’s degree, at least 3 years of experience. Pharmaceutical industry experience is preferred.
Knowledge of analytical chemistry.
Experience working in a laboratory environment; pharmaceutical industry experience is preferred.

Nice To Haves

Leadership experience.
Experience with metrology.
Courses in analytical instrumentation.
Pharmaceutical industry experience.

Responsibilities

Lead the Metrology team and ensure team members have the education, training, and experience needed to perform assigned functions; interview and recommend staff, provide work direction, and coach and develop personnel.
Mentor personnel, manage development and behavior, maintain a professional environment, and review development areas with direct reports.
Communicate and cooperate professionally across the organization, address issues appropriately, and participate in departmental, interdepartmental, and industry meetings as needed.
Serve as a subject matter expert for instrumentation and applicable cGMP compliance, including applicable regulations and guidance such as USP, DEA, EPA, OSHA, and FDA.
Provide information to support planning of instrument and equipment maintenance and calibration activities for equipment end users.
Help develop, implement, and monitor procedures and controls, including SOPs, work instructions, and calibration requirements; evaluate procedures for cGMP compliance.
Bring misuse of instrumentation or equipment to the attention of appropriate department management.
Conduct final reviews of calibration data and instrument qualifications as necessary.
Communicate out-of-calibration results to Quality and senior management, and conduct deviation investigations on out-of-specification calibration results.
Communicate with outside vendors and calibration laboratories, and ensure appropriate coordination and review of third-party calibration results.
Evaluate Metrology systems and processes, implement efficiency and cost-saving improvements, and improve technician productivity while maintaining error-free work.
Participate in FDA, customer, and internal audits, and develop and implement responses to audit deficiencies.
Review and provide input for the departmental budget, approve expenditures as necessary, and conduct internal and external audits as necessary.
Review Pharm Forum and USP materials as necessary, ensure procedures are updated accordingly, and respond to the USP as necessary.
Ensure the calibration program operates under cGMP requirements, the team complies with safety requirements, and personnel are trained on compliance and safety.