QA Engineer

QA Engineer

Job 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 position is responsible for maintaining Process Variance Reports and Annual Product Reviews for the manufacturing and distribution locations, ensuring that budget and schedule remain compliant with contract and department needs.

Responsibilities

• Ensure GMP required documentation complies with governmental regulations such as FDA.
• Monitor and interpret the Federal Register and other sources for laws related to Food, Drugs, and Cosmetic Industries.
• Define and improve systems and processes.
• Maintain the quality system of Process Variance Reports (PVR).
• Generate Annual Product Reviews (APR).
• 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, cost-effectiveness, and production quality.
• Investigate root causes, write and implement CAPAs, and interact with necessary departments to ensure quality investigations and thorough CAPAs.
• 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 and recommend changes to batching instructions.
• Perform Statistical Process Analysis to evaluate process control.

Essential Skills

Additional Skills & Qualifications

Work Environment

The position is based in a manufacturing environment but primarily involves desk work. Occasional visits to the lab or manufacturing areas may be required. The work schedule is Monday to Friday, with an 8-hour shift starting between 7 : 30 AM and 10 : 00 AM, including a 30-minute lunch break. The company culture is highly interactive with a focus on continuous improvement in quality, supporting a team-oriented atmosphere willing to tackle any challenge.

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 :

Workplace Type

This is a fully onsite position in Saint Louis,MO.

Application Deadline

This position is anticipated to close on Dec 5, 2025.