QA Specialist

Overview

Conduct QA investigations, corrective actions, and ensure regulatory compliance.

Key Responsibilities

• regulatory compliance
• microbial testing
• complaint investigation
• document review
• corrective actions
• metrics monitoring

Tasks

-Implement and maintain procedures in strict compliance with 21 CFR Part 820 Quality System Regulations, ISO standards, and other applicable international standards. -Collaborate with customers and technical service representatives to effectively address and resolve any customer issues. -Lead issue review investigations to address concerns raised by customer complaints, ensuring that all issues are thoroughly addressed and resolved. -Test products for microbial performance using ATCC organisms, providing timely and accurate responses to customer inquiries. -Review quality documentation, such as device history records and processing records, to ensure compliance with internal policies and process requirements. -Serve as an expert for complaint/product issues, providing guidance and support to colleagues across the organization. -Monitor and document various metrics, including complaint/product handling, stability testing, and performance, and present them to the Quality Review Board and other relevant parties. -Prepare written responses to quality notifications or inquiries from customers, demonstrating exceptional written communication skills. -Participate in the development, maintenance, and monitoring of programs for compliance with the Quality Systems Regulations (QSR) and internal procedures. -Collaborate with cross-functional teams to successfully implement corrective actions. -Drive internal investigations, including product evaluation and process review, to determine the root cause of quality issues.

Requirements

• fmea
• problem solving
• excel
• powerpoint
• bachelor's
• regulated

What You Bring

-Strong understanding of quality-related tools, such as structured problem solving, data trending, and FMEA (Failure Mode and Effects Analysis). -Bachelor's Degree in a science or related field with some laboratory experience. -2 semesters or 1 year of experience in a laboratory setting using various software programs such as Excel and PowerPoint. -Bachelor of Science Degree in Biology or Microbiology. -Experience in Quality Control Microbiology. -2+ years of experience in a regulated environment such as medical device, pharmaceutical, biotechnology, or clinical. -1 year of experience in a regulated environment such as medical device, pharmaceutical, biotechnology, or clinical.

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Benefits

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

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