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  Participate in Quality processes with a focus on record administration and the troubleshooting of any issues in records management

• Receives, reviews, and classifies incoming quality systems records and supporting materials such as Validations, Batch Records, Lab Notebooks, etc.

• Review Batch Records as required per Quality Compliant Procedures.

• Ensures that records are compliant with Good Documentation Practices and procedural requirements.

• Collaborates with submitters of records to resolve issues.

• Creates files, labels, and barcodes incoming records and prepares them for storage based on the company’s record retention policy.

• Collaborates with submitters to troubleshoot any record issues.

• Manages verbal and written requests for records and locates, retrieves, delivers, and follows up on checked-out records as requested.

• Prepares incoming files for the scanning process.

• Prepares files for regulatory submissions and for audits.

• Scans Device History Records and uploads electronic files into a centralized archiving system.

• Performs technical and clerical assignments involving data entry, proofreading, and other administrative duties.

• Helps with troubleshooting documentation issues via collaboration with records submitters.

• Must be well versed on governing processes for records and be able to identify deficiencies in incoming and outgoing records.

• Work in compliance with Abbott San Diego Distribution Center Quality Management System and Quality Policy Requirements.

• Assist Management with supporting functions relating to the training program (data entry, filing training forms, creation of training files).

• Other duties as assigned.

Minimum Qualifications

• 
  High school diploma or GED

• 1 - 3 years of relevant experience

• Knowledge of MS Office

• Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor

• Must be detail-orientated, self-motivated, and available for flexible scheduling

• Able to collaborate with a variety of site personnel to troubleshoot and solve issues related to records

• Must have reliable transportation.

Education & Experience

• Experience with an electronic document control management system

• Experience with Agile PLM system, preferred.

• Experience in a production / distribution, cGMP, type environment preferred.