What are the responsibilities and job description for the The Maintenance and Calibration Coordinator position at Bell International Laboratories?
The Maintenance & Calibration Coordinator is responsible for the coordination of all corrective maintenance, preventive maintenance, and calibration activities at Bell International Laboratories. The role requires a strong technical and quality background in the pharmaceutical and/or personal care industry. The successful candidate will work cross-functionally with Quality Assurance, Quality Control, and Production teams to support new and ongoing maintenance and calibration initiatives.
Responsibilities
- Maintenance & Calibration Programs:
- Maintain, enhance, and execute the Preventive Maintenance program.
- Work with SMEs to write and/or enhance preventive maintenance procedures.
- Maintain, enhance, and execute the Corrective Maintenance Work Order program.
- Maintain, enhance, and execute the Calibration program.
- Work with and schedule external calibration suppliers.
- General:
- Develop, update, maintain SOPs and provide training as appropriate.
- Ensure maintenance and calibration activities comply with regulatory requirements (e.g., FDA, OTC monographs) and internal quality standards.
- Support quality assurance initiatives by participating in audits and implementing corrective actions as necessary.
Requirements
Required Skills/Abilities
- Working knowledge or background in the pharmaceutical and/or personal care industry.
- Working knowledge of industry best practices for corrective and preventive maintenance.
- Working knowledge of industry best practices for instrument calibrations.
- Strong technical and/or regulatory expertise.
- Detailed record keeping and communication of results to others.
- Project skills appropriate for leadership of validation projects.
- Excellent written, verbal, and interpersonal communication skills.
- High level of initiative, innovation, critical thinking, and problem-solving skills
- Ability to work cross-functionally & at all levels within the organization including senior leadership.
- Ability to prioritize multiple responsibilities and manage deadlines accordingly.
- Communicate effectively and professionally both internally and externally.
- Exceptional attention to detail and high level of accuracy & organization.
- Ability to work as part of a team and excel independently in fast-paced environment.
- Ability to adapt quickly to changing circumstances.
- Demonstrated leadership skills.
- Proficient with Microsoft Office.
Required Education and Experience
- High school diploma or GED.
- Minimum of 3 years of experience in pharmaceutical and/or personal care industry, with at least 2 years of experience with the coordination of maintenance and calibration activities.
- Knowledge of cGMP, FDA regulations, and OTC compliance standards.
Preferred Education and Experience
- Associate’s or Bachelor’s Degree (preferred)
- Lean Six Sigma certification (Green Belt or higher) is a plus.
Physical Demands
- Must be able to lift up to 20 pounds on a regular basis.
- Ability to wear Personal Protective Equipment including a respirator, gloves and eye protection.
- Ability to perform work in a manufacturing environment where there is exposure to occupational hazards.