"Alerted.org

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 guidance’s, 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: • Providing accurate data review and final reports based on education, experience and training • Always be audit ready • Approve result analysis including statements of conformity, decision rules or opinions and interpretations as requested by clients • Authorize results within pre-determined turnaround time (TAT) and ensure that results are right the first time; follow-up with clients when needed • Maintain positive relationships and network effectively and professionally with clients • Adhere to the company Quality Policy • Report client complaints • Participating in the Quality Assurance process as needed • Participate in internal audits and answer questions related to data review • Respond promptly to Quality Assurance and Operations requests and provide same day follow-up if 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 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 • Ensure on-time reporting and communicate to management if assistance is required to meet deadlines • Coordinate thorough data review of results in timely manner without compromising quality • Review and approve computer software audit trails, logbooks and lab worksheets • Ensure accurate and complete test records • Complete assigned CAPAs, change controls and quality plans • Stay current with regulatory and industry standards, trends and advancements • 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 • 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 TECHNICAL SKILLS • Able to effectively communicate • Excellent documentation and technical scientific writing skills • Effectively operate in an evolving, complex and dynamic environment that changes by the hour • 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:

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