QA Engineer

Actalent • Saint Louis, MO • 2h ago

Job Title: QA EngineerJob Description

The primary role of the QA Engineer is to develop and monitor quality management systems and processes to ensure compliance with FDA regulations. The engineer is responsible for maintaining Process Variance Reports and Annual Product Reviews for manufacturing and distribution locations while ensuring that budgets and schedules remain compliant with contract and departmental needs.

Responsibilities

Ensure that GMP-required documentation complies with governmental regulations, such as those from the FDA.

Monitor and interpret the Federal Register and other sources for information on laws pertaining to the food, drug, and cosmetic industries.

Define and improve systems and processes, maintaining the quality system of Process Variance Reports (PVR).

Generate Annual Product Reviews (APR) and conduct customer complaint investigations.

Maintain quality attributes in customer specification portals.

Develop or assist with process control procedures and automation specifications to ensure ongoing compliance.

Evaluate data from current processes to recommend improvements in cost-effectiveness and production quality.

Investigate root causes, write and implement CAPAs, and collaborate with necessary departments to deliver quality investigations.

Use Failure Mode and Effect Analysis (FMEA) and Hazard Operability (HAZOP) Studies to assess systems and processes.

Assist in GMP and GDP training of new personnel.

Create or modify SOPs and work instructions, recommending changes to batching instructions.

Perform Statistical Process Analysis to evaluate process control.

Essential Skills

Broad QA experience in the quality systems area.

Proficiency in project management and ability to function effectively both individually and as part of a team.

Experience in auditing manufacturing areas or involvement in quality investigations such as complaints and deviations.

Exhibit team player qualities, demonstrating cooperation and coordination in all business interactions.

Coordinate resources and communicate project progress, applying project management tools and techniques effectively.

Experience with FDA, audit, deviation, and complaint management.

Additional Skills & Qualifications

Bachelor's Degree in a related Science or Engineering field.

A minimum of two to five years of experience in the manufacturing of food, cosmetics, or pharmaceutical products.

Experience with Quality Systems such as CAPA, deviations, and auditing.

Knowledge of current GMPs and other FDA regulations with the ability to develop technically compliant documents.

Proficiency in Microsoft Office products.

Previous experience in FDA or customer audits.

Work Environment

The role is based in a manufacturing environment but involves desk work with occasional visits to the lab or manufacturing areas. The shift is Monday to Friday, starting between 7:30 AM and 10:00 AM, with an 8-hour workday and a 30-minute lunch break. The culture is very interactive, focusing on continuous improvement and a willingness to contribute to the team, including spending time on the manufacturing floor if needed.

Job Type & Location

This is a Contract to Hire position based out of Saint Louis, MO.

Pay and Benefits

The pay range for this position is $30.00 - $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 Saint Louis,MO.

Application Deadline

This position is anticipated to close on Mar 5, 2026.

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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