Metrology Associate Manager

Nature and Scope

The Associate Manager provides hands on technical support for facility, utility, lab, and manufacturing equipment and associated instruments. Working as part of a multi-disciplinary team, the Associate Manager will ensure any modification, installation, preventative maintenance (as applicable), calibration, operational support, repair, or troubleshooting activity is properly staffed and supported in compliance with engineering specifications, the Food and Drug Administration (FDA), and Good Manufacturing Practices (GMP) guidelines. The individual will be responsible for providing Subject Matter Expertise (SME) for selected aspects of the Calibration program. This position requires the ability to lead, direct, and develop metrology personnel, chair meetings, provide constant, thorough, and professional communication throughout all levels of the organization.

Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Lead all aspects of the Calibration Program.

• Develop, maintain, edit, and follow procedures for the calibration and metrology systems and associated processes to adhere to cGMP's, company, local and state requirements.
• Effectively prioritize metrology workload, assign to staff, track progress and ensure quality of work and associated documentation.
• Ensure support coverage and manage vendor service and contracts when necessary.
• Effectively communicate with subordinates as well as direct management to further department goals and needs. Communicate performance expectations with team, provide feedback, and establish improvement plans when necessary.
• Coordinate metrology shutdown activities and scheduling of calibration/PM/repair work, while working with maintenance and production leadership.
• Lead process improvement projects to improve efficiency, reduce task completion time, improve department budget, increase equipment up time, and improve departmental capabilities.
• Monitor instrument calibration results and implement corrective actions for out of specification conditions, providing technical troubleshooting support serving as an SME in select areas of calibration.
• Maintain department files and documents, support investigations of calibration failures and out of tolerance findings, complete necessary change control documentation.
• Coordinate equipment and instrument breakdown repair activities and serve as customer point of contact.
• Develop training and evaluate personnel. Maintain up to date company required training for all staff. Provide coaching and feedback on training when necessary.

• Position has responsibilities and employees at multiple locations in central Ohio.
• Coordinate and communicate department standardization activities with all Ohio sites department supervision.
• Ensure work orders and calibrations are reviewed in a timely manner.
• Fill in for the Department Manger when the Manager is Out Of Office.

• Perform any other tasks/duties as assigned by management.

Education/Experience Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

Requirements:

• Bachelor's Degree or equivalent job field experience required.

• Minimum 6 years of metrology/calibration experience.
• 3 years in a leadership role required.
• Proficient in the use of Microsoft Office Applications, including Microsoft Word and Excel.
• Job assignments are complex in nature and require excellent planning, project leadership, technical skills, and communication to be successful in meeting project objectives. The associate manager must be able to coordinate and resolve both interpersonal and technical problems and work independently.
• Ability to clearly and concisely express thoughts in written procedures, protocols, and reports. Ability to write procedures that clearly define required tasks. Ability to proofread other's work for accuracy.
• Ability to generate presentations/reports to explain and/or analyze areas of responsibility.
• Comfortable working in production environment with multiple priorities, communicating effectively with those customers.
• Effective oral and written communication skills, acute attention to detail, excellent time and project management skills, and the drive to complete projects thoroughly is required, as is the ability to handle multiple priorities in a fast-changing work environment.
• Comfortable establishing culture of performance. Able to effectively delegate while retaining oversight of important tasks.
• Role Models "can-do" attitude. Reinforces positive approach in daily group activities. Readily adapts to changing job duties. Establishes culture that emphasizes responsiveness.
• Ability to acquire data, to organize, to analyze, and reach accurate conclusions.
• Understanding of maintenance and calibration strategies and techniques. Understanding of Continuous Improvement Principles.
• Experience with calibration systems and metrology concepts.
• Ability to work overtime as needed.

Preferred Skills and Experience

• Knowledge of OSHA requirements and understanding of applicable cGMP, GDP, and FDA requirements.
• Minimum of 1 year of experience in Pharmaceutical Manufacturing or similar FDA regulated environment.
• Creative thinker with good interpersonal relationship skills, strong project management and process improvement skills, as well as strong cross-functional teamwork skills.

Physical Environment and Requirements

Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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