Job Title

Description The QA Review Specialist I will follow internal SOPs, client specific protocols, test plans, validated methods, and/or compendial methods to ensure accurate and true results are reported to clients. The individual will be expected to independently address and resolve simple Quality issues upon discovery. They must demonstrate the ability to operate in compliance with GLP/cGMP guidanceu2019s, ISO/IEC 17025 and industry best practices. The QA Review Specialist I role has a direct influence on lab activities and shall act impartially, be competent and work in accordance with the QMS. The QA Review Specialist I is responsible for data review and accurate final reporting for all clients. Responsibilities include reviewing test data generated by the operations department, being a liaison between the operations department and the Quality Assurance (QA) department and ensuring data integrity is maintained. JOB DUTIES AND RESPONSIBILITIES: u2022 Providing accurate data review and final reports based on education, experience and training u2022 Always be audit ready u2022 Approve result analysis including statements of conformity, decision rules or opinions and interpretations as requested by clients u2022 Authorize results within pre-determined turnaround time (TAT) and ensure that results are right the first time; follow-up with clients when needed u2022 Maintain positive relationships and network effectively and professionally with clients u2022 Adhere to the company Quality Policy u2022 Report client complaints u2022 Participating in the Quality Assurance process as needed u2022 Participate in internal audits and answer questions related to data review u2022 Respond promptly to Quality Assurance and Operations requests and provide same day follow-up if possible u2022 Assist peers as requested and escalate issues to management to ensure swift resolution TECHNICAL RESPONSIBILITIES u2022 Perform QA data review of testing in strict accordance with SOPs, cGMP, cGLP, ISO/IEC 17025, and other applicable regulatory requirements that support client release of intermediates and/or finished products o Routine and non routine tests o Compendial testing (ISO, USP, EP, JP, AMMI etc.) o Custom studies u2022 Ensure on-time reporting and communicate to management if assistance is required to meet deadlines u2022 Coordinate thorough data review of results in timely manner without compromising quality u2022 Review and approve computer software audit trails, logbooks and lab worksheets u2022 Ensure accurate and complete test records u2022 Complete assigned CAPAs, change controls and quality plans u2022 Stay current with regulatory and industry standards, trends and advancements u2022 Perform other additional job-related duties as required Skills Quality assurance, Gmp, glp Top Skills Details Quality assurance,Gmp,glp Additional Skills & Qualifications EDUCATION/EXPERIENCE u2022 BS/BA in a Life Sciences field with 1 to 2 yearsu2019 relevant experience preferred; u2022 1 to 2+ years GMP/GLP laboratory/FDA experience preferred u2022 Related training certifications and self-learning are a plus TECHNICAL SKILLS u2022 Able to effectively communicate u2022 Excellent documentation and technical scientific writing skills u2022 Effectively operate in an evolving, complex and dynamic environment that changes by the hour u2022 Intermediate math skills, bio-statistics preferred Experience Level Entry Level 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: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 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 24, 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 ( ) for other accommodation options.