Quality Assurance Specialist

Title: Quality Assurance Specialist

Location: Pomona, California

Duration: 12 Months

100% Onsite

Responsible for daily batch record operations, batch record review, change control, quality documentation, and compliance activities under the supervision of the Supervisor/Manager.

• 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.

Consultants Eligible Benefits Upon Waiting Period:

• 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
• Met Life Legal, Met Life , and Met Life Pet Insurance
• 401(k)

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, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.