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Job Title: Quality Assurance Review Specialist IJob Description

The Quality Assurance Review Specialist I is responsible for following internal SOPs, client-specific protocols, test plans, validated methods, and/or compendial methods to ensure that accurate and true results are reported to clients. The individual will independently address and resolve simple Quality issues and must demonstrate the ability to operate in compliance with GLP/cGMP guidance, ISO/IEC, and industry best practices. This role has a direct influence on lab activities, requiring the individual to act impartially, be competent, and work in accordance with the QMS.

Responsibilities

+ Provide accurate data review and final reports based on education, experience, and training.

+ Maintain audit readiness at all times.

+ Approve result analyses, including statements of conformity, decision rules, or opinions and interpretations as requested by clients.

+ Authorize results within pre-determined turnaround time (TAT) and ensure accuracy; follow-up with clients when needed.

+ Maintain positive relationships and network effectively with clients.

+ Adhere to the company Quality Policy and report client complaints.

+ Participate in the Quality Assurance process and internal audits, and respond promptly to Quality Assurance and Operations requests.

+ Assist peers as requested and escalate issues to management to ensure swift resolution.

+ Perform QA data review of testing in strict accordance with SOPs, cGMP, cGLP, ISO/IEC, and other applicable regulatory requirements.

+ Coordinate thorough data review of results in a timely manner without compromising quality.

+ Review and approve computer software audit trails, logbooks, and lab worksheets.

+ Ensure accurate and complete test records and complete assigned CAPAs, change controls, and quality plans.

+ Stay current with regulatory and industry standards, trends, and advancements.

Essential Skills

+ BS/BA in a Life Sciences field with 1 to 2 years’ relevant experience preferred.

+ 1 to 2+ years GMP/GLP laboratory/FDA experience preferred.

+ Related training certifications and self-learning are a plus.

+ Effective communication skills.

+ Excellent documentation and technical scientific writing skills.

+ Ability to operate effectively in an evolving, complex, and dynamic environment.

+ Intermediate math skills, bio-statistics preferred.

Work Environment

This position operates within a full-time, on-site setting. The work involves physical abilities such as the ability to lift 5+ pounds and perform repetitive motion tasks with hands and arms while typing/writing. The environment requires maintaining a clean and safe work area and ensuring that personal protective equipment (PPE) is worn at all times in the lab. The team consists of 7 members, with 1 supervisor. Reasonable accommodation will be made for persons with disabilities.

Job Type & Location

This is a Contract to Hire position based out of Hercules, CA.

Pay and Benefits

The pay range for this position is $28.00 - $36.00/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 Hercules,CA.

Application Deadline

This position is anticipated to close on Dec 31, 2025.

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 [email protected] (%[email protected]) for other accommodation options.