Supervisor Metrology

Bora Pharmaceuticals•Maple Grove, MN

11d•$88,000 - $115,000

About The Position

The Supervisor Metrology leads the Metrology group, whose personnel qualify, maintain, and calibrate laboratory instruments and calibrate manufacturing and packaging equipment. The supervisor ensures that laboratory instrumentation is identified, qualified, calibrated, and maintained appropriately, and that manufacturing and packaging equipment is properly calibrated. The role provides technical support for purchasing and maintaining instrumentation and equipment and conducts final reviews of calibration and maintenance documentation. It also provides leadership and technical expertise in response to issues such as instrument investigations and CAPAs, and ensures the calibration program complies with cGMP requirements and the team follows safety programs. The supervisor guides and develops staff, plans and monitors maintenance and calibration activities, maintains compliant procedures and controls, and serves as a subject matter expert on instrumentation and applicable cGMP requirements. The role communicates out-of-calibration results, conducts deviation investigations, coordinates with vendors and third-party laboratories, improves systems and processes, supports audits and deficiency responses, and contributes to departmental budgeting. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

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

Provide leadership, work direction, coaching, and development for the Metrology team; support staffing decisions and maintain a professional environment.
Ensure team members have the education, training, and experience needed for assigned functions, including compliance and safety training.
Plan and support instrument and equipment maintenance and calibration activities for end users.
Develop, implement, monitor, and evaluate procedures and controls, including SOPs, work instructions, and calibration requirements, for cGMP compliance.
Serve as a subject matter expert on instrumentation and applicable cGMP compliance; apply relevant regulations and guidance, including USP, DEA, EPA, OSHA, and FDA requirements.
Identify and communicate misuse of instrumentation or equipment to 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 investigate out-of-specification calibration results.
Coordinate with outside vendors and calibration laboratories and review third-party calibration results.
Evaluate Metrology systems and processes and implement efficiency and cost-saving improvements while maintaining accurate work.
Participate in FDA, customer, and internal audits; develop and implement responses to audit deficiencies.
Review and provide input on the departmental budget and approve expenditures as necessary.
Conduct internal and external audits, as necessary.
Review Pharm Forum and USP information, update procedures accordingly, and respond to USP, as necessary.
Participate in departmental, interdepartmental, and industry meetings and maintain effective communication and professional collaboration across the organization.