Quality Assurance Specialist
Abbott
Title: Quality Assurance Specialist Location: Pomona, California Duration: 12 Months 100% Onsite
Summary Responsible for daily batch record operations, batch record review, change control, quality documentation, and compliance activities under the supervision of the Supervisor/Manager.
Key Responsibilities
Summary Responsible for daily batch record operations, batch record review, change control, quality documentation, and compliance activities under the supervision of the Supervisor/Manager.
Key Responsibilities
- Perform batch record review, record administration, and batch release activities.
- Review and generate Certificates of Analysis (COA) and Certificates of Conformance (COC).
- Manage and track Change Control activities.
- Review SOPs, manufacturing records, logs, forms, and quality documents.
- Coordinate with cross-functional teams to resolve Device History Record (DHR) issues.
- Verify product information using databases.
- Ensure compliance with QSRs, ISO 13485, CMDR, and company quality systems.
- Troubleshoot quality issues, recommend improvements, and coach team members.
- Maintain documentation, file records, and support labeling activities.
- Perform other duties as assigned.
- High School Diploma or GED.
- 3-5 years of related experience.
- Experience with MS Office.
- Detail-oriented with strong communication, problem-solving, and organizational skills.
- Ability to work independently and as part of a team.
- Bachelor's Degree.
- Experience in medical device manufacturing (preferably in-vitro diagnostics).
- Knowledge of Quality System Regulations.
- Medical and Prescription Drug Plans
- Dental Plan
- Vision Plan
- Health Savings Account (for High Deductible Health Plans)
- Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
- Supplemental Life Insurance
- Short Term Disability (coverage varies by state)
- Long Term Disability
- Critical Illness, Hospital coverage, Accident Insurance
- MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
- 401(k)
- Published on 09 Jul 2026, 8:23 PM
Vacancy posted 3 days ago
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