Quality Assurance Specialist

Job Title: Quality Assurance SpecialistJob Description

We are seeking a meticulous and detail-oriented Quality Assurance Specialist to join our team on a temporary basis, covering a leave of absence for six months with the possibility of a permanent position based on business needs. This role is integral to ensuring our high standards of quality are met in all aspects of production.

Responsibilities

• Perform batch record reviews for both electronic and paper batches.
• Review data and verify manufacturing processes to ensure compliance with operating procedures and specifications.
• Organize and review in-process control samples for transfer.
• Support quality initiatives, including the initiation and data support for resolving quality issues.
• Provide Quality oversight over the Quality System, including the review of reports, data, and records supporting manufacturing and distribution.
• Conduct timely Quality reviews of data utilized to support batch releases.
• Assist in ensuring compliance with regulatory requirements related to product safety and quality.
• Ensure procedures follow FDA, ICH, Standard methods, and Quality System requirements.
• Review records to ensure data integrity meets Industry standards.

Essential Skills

• Bachelor's degree in Science with 5-6 years of relevant experience.
• Experience with Labware in a GMP environment and batch record reviewing.
• Strong attention to detail with excellent communication and critical thinking skills.
• Knowledge of quality assurance, document control, batch records, and validation processes.

Additional Skills & Qualifications

• Experience in a medical device or pharmaceutical environment is ideal.
• The ability to work independently and ask questions confidently.
• Familiarity with corrective action plans.

Work Environment

The work environment is dynamic and fast-paced, reflecting the high standards and demands of the medical device industry. The role requires onsite attendance from Monday to Friday with some flexibility in start times. Reliable and predictable attendance is a must. Benefits include medical, dental, and vision coverage, holiday, PTO, and sick pay. The role includes occasional weekend work and on-call responsibilities as needed.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $43.00 - $43.00/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.

Application Deadline

This position is anticipated to close on Mar 31, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.