Quality Assurance Specialist

Abbott · Pomona, CA · 5 days ago

Quality AssuranceContract

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.
Coincide 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.

Minimum Qualifications

A 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.

Preferred Qualifications

A Bachelor's Degree.
Experience in medical device manufacturing (preferably in-vitro diagnostics).
Knowledge of Quality System Regulations.

Benefits

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)

About the Role

The Quality Assurance Specialist will be responsible for daily batch record operations, batch record review, change control, quality documentation, and compliance activities under the supervision of the Supervisor/Manager.