QA Engineer

Overview

Develop and monitor QA systems ensuring FDA compliance in manufacturing

Key Responsibilities

• process control
• statistical analysis
• capa management
• fmea hazop
• regulatory compliance
• sop development

Tasks

-Develop or assist with process control procedures and automation specifications to ensure ongoing compliance. -Define and improve systems and processes. -Perform Statistical Process Analysis to evaluate process control. -Assist in GMP and GDP training of new personnel. -Maintain the quality system of Process Variance Reports (PVR). -Evaluate data from current processes to recommend improvements, cost-effectiveness, and production quality. -Ensure GMP required documentation complies with governmental regulations such as FDA. -Conduct customer complaint investigations. -Maintain quality attributes in customer specification portals. -Generate Annual Product Reviews (APR). -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. -Monitor and interpret the Federal Register and other sources for laws related to Food, Drugs, and Cosmetic Industries. -Create or modify SOPs and work instructions and recommend changes to batching instructions.

Requirements

• capa
• quality systems
• fda
• gmp
• ms office
• bsc

What You Bring

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

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Benefits

-Medical, dental & vision -Health Spending Account (HSA) -Short and long-term disability -Critical Illness, Accident, and Hospital -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Transportation benefits -Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms