Quality Assurance Associate

Job Title:

Quality Assurance Associate

Job Description

The Quality Assurance Associate will be responsible for ensuring compliance with operating procedures and specifications by monitoring lab and manufacturing processes. This role involves receiving samples, creating a chain of custody in the SAP system, and utilizing E  and Excel to perform various process monitoring tasks. The QA Associate will provide oversight on manufacturing processes, ensuring data integrity and compliance. Additionally, the role includes staging samples for testing and reviewing documentation for accuracy, while practicing Good Documentation Practices (GDP).

Responsibilities

• Monitor lab and manufacturing process verifications for compliance.

• Receive samples and create a chain of custody in the SAP system.

• Perform process monitoring, labeling control, reinspection, and sampling for reserved samples using E  and Excel.

• Provide quality oversight on manufacturing processes to ensure compliance and data integrity.

• Support the resolution of quality issues.

• Stage samples for testing by the microbiology or chemistry departments.

• Review and ensure the accuracy of documentation.

• Input samples into SAP and track them using E  and Excel.

• Train entry-level individuals on chain of custody and labeling room procedures.

Essential Skills

• Ability to work under general supervision.

• Confidence to ask questions and work independently, especially during night shifts.

• Strong attention to detail with excellent communication and critical thinking skills.

Additional Skills & Qualifications

• Bachelor's degree in Science with 0-1 years of experience, or High School Diploma with 2 years of experience in GMP quality assurance or QC within medical device or pharma.

• Knowledge of sterilization, quality assurance, inspection, SOP, and document control.

• Experience in quality engineering, corrective action plans, and validation.

Work Environment

The work environment is dynamic and fast-paced, reflecting the high standards of the medical device industry. This is an onsite role with a night schedule from Sunday to Tuesday, and the following week from Sunday to Wednesday, 6pm-6am. Training will be on the first shift from 8am-5pm for three weeks, after which the individual will transition to the night shift. Reliable and predictable on-site attendance is necessary.

Flexibility to work additional shifts or be on call is required. The facility operates with high standards for safety and precision.

• This posting is for an existing vacancy.

Job Type & Location

This is a Contract position based out of Irvine, CA.

Pay and Benefits

The pay range for this position is $28.00 - $30.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Irvine,CA.

Final date to receive applications

This position is anticipated to close on Feb 26, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom (%20actalentaccom) for other accommodation options.