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UPS Supply Chain Solution (SCS) is seeking a Healthcare Calibration Supervisor to provide guidance to UPS SCS management to maintain calibration of devices used to monitor environmentally-controlled Healthcare storage areas such as warehouses, cold chambers, vaults, etc. He/She assess different types of devices being evaluated for use in healthcare storage applications, identifies calibration requirements and elevates calibration issues appropriately. This position provides training and subject matter expertise to other functions as needed. The Healthcare Calibration Supervisor creates calibration records, summary results of calibration activities and schedules for upcoming calibration activities and reviews calibration records. He/She performs required calibration activities, works to resolve any issues found and creates summaries of results. This position determines applicable regulations and requirements for calibrating devices used to monitor environmentally-controlled Healthcare products, and supports client/regulatory audits and inspections. The Healthcare Calibration Supervisor is part of the UPS SCS Global Healthcare Calibration Management team and reports to the Healthcare Facility Validation Engineer.

Responsibilities and Duties

• Remains current on applicable global regulatory requirements, accepted guidance (ISPE) and industry best practices (e.g. Pharmaceutical, Medical Devices, etc.) related to calibration of devices used in environmentally-controlled storage areas

• Serves as subject matter expert to other functions regarding requirements and best practices for calibration of devices involved, and provides general calibration training as needed to other groups

• Identifies and assesses devices used for monitoring environmentally-controlled Healthcare storage areas to be compliant with current Good Manufacturing Practices (cGMP)regulations

• Assesses current Supply Chain Solutions (SCS) calibration procedures to determine SCS's ability to meet client requirements and proposed solutions

• Develops plans to calibrate devices used environmentally-controlled Healthcare storage areas to meet predetermined intervals

• Reviews technical documents and drawings (sensor cutsheet and layout drawings) provided by UPS Plant Engineering or design/installation vendors that describe each component and will require calibration

• Documents calibration test results, makes adjustments as needed to device readings and generate summary of test results

• Provides updates to facility management on status of calibration activities and any devices found out of tolerance

• Establishes and maintains audit programs for facilities, chambers or systems to ensure calibration documentation is being maintained properly

• Analyzes historical data to determine any impact to product for devices found to be out of tolerance during calibration

• Provides updates to Facility Validation management, either verbally or through written reports or communications, on the status of ongoing calibration activities related to facilities, chambers or systems

• Participates in regulatory agency/client inspections to assist with presenting calibration documentation to auditors

• Assists in agency/client follow-ups after inspections to ensure all audit findings are addressed

• Assists with review and revision of some corporate standard operating procedures (SOPs) and work instructions (WIs) to ensure proper procedures are followed by Plant Engineering, Quality Assurance and Operations Groups

• Reviews and suggests revisions to change control procedures, training, and audits to ensure the maintenance of calibration

• Stays up-to-date on training for all applicable UPS SCS Healthcare SOPs and Work Instructions and general UPS training (annual safety, hazcom, lockout/tagout, etc.)

• Assists in establishing and completing risk assessment procedures and processes to support risk minimization

Knowledge and Skills

• Must be available to travel as needed

• Proficient in Microsoft Office programs

• Bachelor's Degree (or internationally comparable degree) in Engineering, Science or related field - Preferred

• Calibration experience - Preferred

• HVAC and controls experience - Preferred

• Healthcare Industry experience - Preferred

• Relevant QA/RA experience - Preferred

UPS is an equal opportunity employer. UPS does not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity or any other characteristic protected by law

Company: UNITED PARCEL SERVICE

Category: Operations

Requisition Number: 323633

Location: Louisville,Kentucky