Job Description

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Summary:

Provides administrative support to QA Asset Management Calibration Department. Database management data processing, record creation, data entry, filing and archiving of records, equipment compliance verifications, equipment status changes, review of equipment binders and equipment change control workflows. Other duties are listed below.

*Overtime may be required at times.

Essential Duties and Responsibilities:

Incumbent is responsible for performing a variety of work functions related to supporting the equipment calibration system. Incumbent will maintain the equipment calibration database. Support process and asset inductions and assist with calibration laboratory day to day operations, as necessary.

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

• Updates the electronic Equipment Master List (database) with current information for incoming new equipment, changes to equipment location, owner and status, completed calibration and maintenance activities, and equipment station configuration changes.

• Monitors the equipment database on a daily basis to ensure timely processing of equipment records in Open, Pending, Quarantine, Active, Retired, Inactive, and change control status.
• Reviews calibration and maintenance records/inventory lists for accuracy against database information.
• Updates calibration and maintenance schedules, as needed.
• Scans calibration certificates and uploads them into the equipment database
• Performs area walk through audits of equipment against the Equipment Master List.
• Notifies appropriate personnel of equipment binders requiring initiation or revision.
• Files and/or archives hardcopy calibration, maintenance, supplier quality, product release, and receiving inspection records.
• Assists calibration technicians with initiation of out-of-tolerance records, hardcopy filing, and updates to the equipment database records for calibrations performed.
• Assists supplier QE\'s, Operations Maintenance, and QA Inspectors with filing and/or archiving of records and other administrative duties.
• Use MS Office applications, Word, Excel, Blue Mountain RAM software, and other Computer related programs.
• Generates periodic project status reports and metrics to manager or supervisor, as required.
• Provides training and guidance to RAM users and supports process improvement teams through input at meetings, review of procedure redlines, and implementation of changes.
• Provides administrative and QA/QC support on special projects, as required.
• Maintains quality metrics and reports, as required, and implements appropriate preventive/corrective action to improve quality.
• Assist Calibration Supervisor with new processes and make processes improvement recommendation.
• Act as a mentor and assist on employees training on equipment controls, database operation, or other job related systems.
• Assumes and performs other duties as assigned.

• Experience with using asset management software database
• Experience reviewing documentation for accuracy and compliance.

• Experience generating reports, adding records, updating histories, and performing data entry in the calibration database
• Experience with medical device manufacturing
• Calibration software experience
• Previous work experience in an FDA or regulated industry
• Experience working with GMP practices
• Calibration database management and navigation experience, Blue Mountain (RAM) Software is preferred.

• Diploma or equivalent.

• Typically requires a minimum of 4-6 years of industry experience or equivalent.
• Preferred: At least 2 years related calibration experience or equivalent combination of education and experience

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