Job Details

QA Review Specialist I

The QA Review Specialist I will follow internal SOPs, client-specific protocols, test plans, validated methods, and/or compendial methods to ensure accurate and reliable results are reported to clients. The individual will be expected to independently address and resolve simple quality issues upon discovery and must demonstrate the ability to operate in compliance with GLP/cGMP guidelines, ISO/IEC 17025 standards, and industry best practices. This role directly influences laboratory activities and requires impartiality, technical competence, and adherence to the Quality Management System (QMS). The QA Review Specialist I is responsible for data review and accurate final reporting for all clients, including reviewing test data generated by the operations department, serving as a liaison between Operations and Quality Assurance (QA), and ensuring data integrity is maintained throughout all processes.

Job Duties and 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 interpretations as requested by clients.
• Authorize results within pre-determined turnaround times (TAT) and ensure first-time accuracy; follow up with clients when needed.
• Maintain positive, professional relationships with clients and represent the company effectively.
• Adhere to company Quality Policy and report any client complaints.
• Participate in the Quality Assurance process as needed, including internal audits and data review discussions.
• Respond promptly to QA and Operations requests, providing same-day follow-up when possible.
• Assist peers as requested and escalate issues to management to ensure swift resolution.

Technical Responsibilities

• Perform QA data review of testing in strict accordance with SOPs, cGMP, cGLP, ISO/IEC 17025, and other applicable regulatory requirements supporting client product release.
• Routine and non-routine testing.
• Compendial testing (ISO, USP, EP, JP, AMMI, etc.).
• Custom studies.
• Ensure on-time reporting and communicate with management if assistance is needed to meet deadlines.
• Coordinate thorough data review of results in a timely manner without compromising quality.
• Review and approve software audit trails, logbooks, and laboratory worksheets.
• Ensure all test records are accurate, complete, and compliant.
• Complete assigned CAPAs, change controls, and quality plans.
• Stay current with regulatory standards, industry trends, and advancements.
• Perform other related duties as assigned.

Skills

• Quality Assurance
• GMP
• GLP

Education and Experience

• BS/BA in Life Sciences or a related field, with 12 years of relevant experience preferred.
• 12+ years of GMP/GLP laboratory or FDA-regulated experience preferred.
• Related training certifications and self-directed learning are a plus.

Technical Skills

• Effective communication and interpersonal skills.
• Excellent documentation and scientific writing abilities.
• Ability to operate effectively in a dynamic, evolving environment.
• Intermediate math skills; biostatistics knowledge preferred.

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 Nov 20, 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 ...@actalentservices.com for other accommodation options.