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Job Title: QA SpecialistJob Description

We are seeking a proactive and detail-oriented Quality Assurance (QA) Associate to support clinical and commercial manufacturing operations. This role will focus on reviewing and managing documentation for registration and clinical batches, ensuring compliance with regulatory requirements, and supporting R&D and feasibility projects. The ideal candidate will be comfortable working independently on smaller projects, collaborating cross-functionally, and maintaining high standards of quality and accountability.

Responsibilities

+ Review and understand batch records, manufacturing protocols, and registration/clinical batch documentation.

+ Ensure documentation aligns with FDA and other regulatory agency requirements.

+ Manage deviations, change controls, and CAPAs as they arise.

+ Evaluate method validation and equipment qualification protocols and reports.

+ Ensure SOPs are followed and documentation is complete and accurate.

+ Provide feedback on validation documents and ensure alignment with regulatory expectations.

Essential Skills

+ Quality assurance experience with a focus on batch record review and GMP compliance.

+ 2-4 years of experience in a QA role, specifically in document review of Batch Records, Equipment Records, Validation Records, etc.

+ Collaboration and initiative to seek help or additional work.

+ Attention to detail and accountability.

+ Ability to prioritize tasks and review protocols effectively.

Additional Skills & Qualifications

+ AS/BS Degree Preferred, HS Diploma Required.

+ 2+ years in a Quality/GMP Environment with at least 2 years directly in a QA role.

+ Pharmaceutical industry experience strongly preferred.

+ Experience reviewing batch records in a commercial setting and understanding supporting documents such as Deviations and Change Controls.

+ Well-rounded experience in reviewing documentation for GMP compliance.

Work Environment

The QA Specialist will work on the R&D side of the building, which offers a quieter environment than the operations side. The role involves walking through scale-up production environments or entering the operations building for final clinical batch compliance. The position provides an individual office space, with primarily onsite work and occasional flexibility for minimal remote work if necessary. The work schedule is Monday to Friday, from 7:30 AM to 4:00 PM, or a similar variation. Collaboration with internal teams is essential, and the position occasionally supports CDMO-related tasks. The role promises exposure to diverse QA experiences and a supportive R&D team, with potential for role extension into 2026.

Pay and Benefits

The pay range for this position is $25.00 - $30.00/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 Bridgeton,MO.

Application Deadline

This position is anticipated to close on Aug 6, 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.