QA Records Specialist – 2nd Shift (Onsite)

Abbott; San Diego (CA); On-site; USD 30,000 - 39,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

401(k)

Job summary

Abbott in San Diego is seeking a QA Specialist I for the 2nd shift (2:30 PM – 11:00 PM) on a 6‑month assignment. The role focuses on quality records management, including receiving, reviewing, and classifying Validations, Batch Records, Lab Notebooks, and related materials, while ensuring compliance with Good Documentation Practices.

You will prepare files for scanning and regulatory submissions, scan Device History Records, and contribute to audits.

Qualifications

• High school diploma or GED required.
• 1–3 years of relevant experience.
• Knowledge of MS Office.
• Able to work on multiple tasks as a team member and/or individual contributor.
• Must be detail-oriented, self-motivated, and available for flexible scheduling.
• Able to collaborate with site personnel to troubleshoot records issues.
• Must have reliable transportation.
• Experience with electronic document control management systems.
• Experience with Agile PLM system preferred.
• Experience in production/distribution, cGMP environment preferred.

Responsibilities

• Participate in quality processes with a focus on record administration and troubleshooting issues in records management.
• Receives, reviews, and classifies incoming quality system records and supporting materials such as Validations, Batch Records, Lab Notebooks, etc.
• Review Batch Records as required per Quality procedures.
• Ensure records are compliant with Good Documentation Practices and procedural requirements.
• Collaborate with submitters of records to resolve issues.
• Create files, labels, and barcodes for incoming records and prepare for storage per retention policy.
• Scan Device History Records and upload to centralized archiving system.
• Perform data entry, proofreading, and other administrative duties.
• Assist with training program documentation and related tasks.

Skills

Detail-oriented

Multi-tasking

Team collaboration

Education

High school diploma or GED

Tools

MS Office

Electronic document control management system

Agile PLM

Job description

Abbott in San Diego is seeking a QA Specialist I for the 2nd shift (2:30 PM – 11:00 PM) on a 6‑month assignment. The role focuses on quality records management, including receiving, reviewing, and classifying Validations, Batch Records, Lab Notebooks, and related materials, while ensuring compliance with Good Documentation Practices.

You will prepare files for scanning and regulatory submissions, scan Device History Records, and contribute to audits.