Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
Pay Range 22-27$/hour.
Position Summary
Under the supervision of the Lead or Supervisor, the scope of this position is responsible for carrying out the daily operations in the Quality department.
Duties and Responsibilities
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.
This position is based in San Diego and may require up to 30% of travel.
The salary for this role is between $17 – $35
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