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Summary of Objective: The Metrology Manager will utilize knowledge of measurement science, mathematics, physics, and electronics to identify and/or create documented methods or procedures to calibrate and verify equipment calibrations. This position acts independently to coordinate all work for the calibration team ensuring that calibrations are performed accurately and on time in accordance with the calibration schedule to prevent observations and warning letters. This position will also be responsible for assisting in investigations and customer or regulatory audits. The Metrology Manager may be authorized to report opinions and interpretations as needed by management.

Essential Duties and Responsibilities:

• Ability to read and interpret equipment manuals, drawings, specifications in order to develop calibration procedures and methods according to detailed specification and technical requirements.

• Oversee the development and compliance of calibration schedules and corrective maintenance for

• equipment to support applicable procedures and processes.

• Collect, compile, measure and record data gathered from on and offsite calibrations and analyze

• measurement data for identifying abnormal trends and evaluate the effectiveness of calibration system.

• Maintain and ensure the validity of the equipment history database.

• Apply continuous improvement assessments to the calibration program to ensure it meets the needs of the organization and complies with all relevant regulations.

• Proactively manage vendors by establishing clear service level expectations, monitoring performance, and providing timely and accurate communication.

• Ensure staff receive appropriate knowledge, skill development, and growth opportunities.

• Identify and manage objectives for team members and provide regularly scheduled feedback throughout the year.

• Supervise staff; including, but not limited to, organize, and prioritize work, write/conduct performance reviews and manage work performance.

• Develop and train team members on new calibration procedures and assist in executing and documenting the processes.

• Adapt and upgrade existing calibration equipment, standards, and techniques to accomplish daily tasks.

• Provide metrology guidance for all projects as required.

• Develop and maintain the departmental budget; including, but not limited to, planning for capacity expansion, equipment needs, and scale up measures.

• Ensures all activities are executed following quality and regulatory standards.

• Prepare and/or review calibration reports and certificates.

• Participate in customer and regulatory audits.

• Conduct technical audits of calibration laboratory to verify traceability of standards and compliance with published standards and guidelines.

• Develop, implement, and maintain the calibration laboratory’s quality systems per published standards and guidelines.

• Coordinate and guide calibration activities of calibrations group to complete tasks and calibrations in order to complete calibrations on time per the site calibration schedule.

• Manage site calibration schedule and assist in completing calibrations as needed to achieve completed monthly calibration status.

• This position may require overtime and/or weekend work.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

• Attendance to work is an essential function of this position.

• Performs other duties as assigned by the Manager.

Qualifications:

Required:

• Bachelor's Degree in a related field and/or 1-3 years related experience and/or training.

• College Level Mathematical Skills - Intermediate

• Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.

• Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.

• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

• Driver's License

Preferred:

• Ability to follow instructions and respond to management direction.

• Ability to identify and resolve problems in a timely manner.

• Ability to demonstrate attention to detail. - Ability to effectively present information to various people as the job requires.

• Ability to maintain calibration databases and procedures.

• Ability to display a willingness to make decisions.

• Ability to show success in managing employees.

• Ability to exhibit sound and accurate judgment.

• Ability to set and achieve challenging goals.

• Ability to display excellent time management skills.

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Equal Employment Opportunity (EEO) Statement:

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled