Quality Assurance Specialist

Abbott; Pomona (CA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Supplemental Life Insurance

Short Term Disability

Long Term Disability

Critical Illness, Hospital coverage, &

MetLife Benefits & Pet Insurance

Job summary

Abbott is seeking aQuality Assurance Specialist in Pomona, CA. This 12‑month, on-site role supports daily batch record operations, reviews, change control, and quality documentation under supervision.

The role involves cross-functional coordination, document control, and ensuring compliance with QSRs, ISO 13485, and CMDR. Strong communication and teamwork are essential.

Qualifications

• High School Diploma or GED required.
• 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.

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.

Skills

Attention to detail

Strong communication

Problem solving

Organizational skills

Team collaboration

Independent work

Education

High School Diploma or GED

Bachelor's Degree

Tools

MS Office

Job description

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

• 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.

Minimum Qualifications

• 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

• 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
• MetLife Legal, MetLife ID Fraud, and MetLife 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.