QA Deviation Investigator

Overview

Investigate and resolve quality deviations using root cause analysis and CAPA.

Key Responsibilities

• data analysis
• root cause
• corrective actions
• client communication
• investigation reporting
• findings documentation

Tasks

-Collaborate with departments to gather information and implement corrective actions. -Communicate recommendations based on investigation outcomes. -Participate in client communications and responses. -Collect and analyze data related to deviations to identify patterns, trends, or potential causes. -Provide timely written documentation of investigations. -Analyze deviations or non-conformances using problem-solving tools like root cause analysis. -Document findings in a comprehensive and objective manner.

Requirements

• technical writing
• root cause
• lean sixsigma
• gmp
• capa
• science degree

What You Bring

-Ability to work effectively in a fast-paced environment and prioritize tasks. -1+ years of experience in technical writing and/or deviation writing. -1+ years of experience with problem-solving tools (Root Cause Analysis and/or LEAN/six sigma). -Experience in a regulated environment, preferably in biologics/pharmaceuticals. -Technical writing and quality processes expertise. -Solid technical writing and communication skills. -Knowledge of pharmaceutical, GMP, and FDA regulations. -Experience with CAPA, quality assurance, root cause analysis, and deviations. -Bachelor's degree in biology, biochemistry, chemistry, or a science-related field. -Ability to facilitate meetings for desired outcomes. -Ability to evaluate data and make recommendations based on trends. -3+ years of experience in a regulated environment.

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Benefits

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

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.

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