QA Engineer

Actalent•Saint Louis, MO

77d•$30 - $30•Onsite

About The Position

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.

Requirements

Experience in quality assurance, particularly in managing open CAPAs post-audit or investigation.
Ability to coordinate with multiple departments to drive open CAPAs to completion.
Broad QA experience in Quality Systems and project management.
Experience managing CAPAs in a lab, QC, or manufacturing environment.
Knowledge of FDA regulations and GMPs.
Proficiency in Microsoft Office products.
Bachelor's Degree in a related Science or Engineering field.
2-5 years' experience in manufacturing of food, cosmetics, or pharmaceutical products.
Experience with Quality Systems such as CAPA, deviations, auditing.

Nice To Haves

Auditing experience in manufacturing areas or involvement in quality investigations is a plus.

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.