Metrology Manager

I: Job Summary

The Metrology Manager oversees the Metrology program and leads the calibration technicians, while ensuring alignment with JJA’s core values of Quality, Accuracy, and Integrity. This role is responsible for maintaining compliance with company and client policies and procedures, as well as applicable regulatory requirements. A successful Metrology Manager is a self-motivated leader with a positive attitude, strong technical expertise, and sound leadership skills. They must possess the knowledge and experience necessary to effectively manage the Metrology program within GxP-regulated environments, driving excellence and best practices.

II: Responsibilities

Metrology Program Management:

• Develop, revise, implement, and periodically review Metrology Standard Operating Procedures (SOPs), work instructions, and best practices to ensure accuracy, consistency, and reliability of calibrations.
• Responsible for overseeing the calibration and adjustment of equipment to specified tolerances using prescribed SOPs and manufacturer manuals.
• Responsible for the procurement, use, handling, storage, calibration, and inventory of calibration standards.
• Review and maintain executed records of calibrations and repairs. Ensure all documentation meets quality and GxP requirements.
• Develop and maintain Metrology training program.
• Ensure calibration work is performed safely and in compliance with EHS requirements.

Team Leadership:

• Provide training, guidance, and mentorship to Metrology team members to ensure proficiency and professional growth.
• Establish goals, objectives, and accountabilities for Metrology staff and evaluate staff performance.
• Set priorities and manage scheduling of internal calibration activities to ensure calibrations are performed to schedule.
• Maintain positive and productive working relationships with peers, clients, and leadership.

Quality Assurance and Compliance:

• Responsible for the storage, retention, and retrieval of calibration records within ProCal Direct.
• Ensure compliance with relevant industry standards, regulatory requirements, external regulations, guidelines, client requirements, and internal quality management system (QMS).
• Conduct audits and assessments to verify adherence to Metrology procedures. Collaborate with leadership to address non-conformities and implement corrective actions.
• Perform quality functions including deviation initiation and impact assessment for Out of Tolerance events. Generate and investigate associated reverse traceability reports.
• Utilize root cause analysis to implement corrective and preventive actions to prevent future deviations with the same or similar root cause(s).

Continuous Improvement:

• Interpret instrument performance trends to identify opportunities for process optimization.
• Lead and support initiatives to implement new measurement techniques, tools, and technologies.
• Seek to improve the overall function of the department by anticipating problems and initiating appropriate actions to eliminate them. Identify and suggest initiatives for continuous improvement of process, quality, safety and efficiency.

III: Education, Experience & Skills

• 10 years in the field of Metrology with 3 years in the pharmaceutical GMP industry.
• 2 years in a supervisory Metrology role.
• Certified Calibration Technician preferred.
• Proficient in Microsoft Office 365. Experience with ProCal Direct preferred.
• Knowledge of pharmaceutical equipment, facilities, standards and processes required.
• Excellent oral, written and interpersonal communication skills.
• Must be able to prioritize a diverse workload while applying creative problem solving.
• Adept at using critical thinking to solve technical problems.
• Excellent time management skills and the ability to handle several tasks simultaneously.

Job Type: Full-time

Pay: $125,000.00 - $145,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to Commute:

• Gaithersburg, MD (Preferred)

Ability to Relocate:

• Gaithersburg, MD: Relocate before starting work (Preferred)

Work Location: Hybrid remote in Gaithersburg, MD

Salary : $125,000 - $145,000