Quality Specialist

Overview

Support GMP compliance, QA operations, and investigations for cell & gene therapy manufacturing.

Key Responsibilities

• root cause
• gmp compliance
• document review
• process improvement
• batch review
• quality support

Tasks

-Collaborate cross-functionally with Manufacturing, Quality Control, and Supply Chain teams to resolve quality issues. -Lead and drive investigations into deviations, non-conformances, environmental excursions, and process anomalies. -Apply structured root cause analysis tools such as 5 Whys, Fishbone (Ishikawa), and FMEA to support investigations. -Support continuous improvement initiatives to enhance quality, compliance, and operational efficiency. -Ensure all manufacturing activities comply with GMP and regulatory requirements. -Review and approve GMP documentation such as batch records, SOPs, test methods, validation protocols, and technical reports for accuracy and compliance. -Participate in and support internal audits, facility walkthroughs, and regulatory inspections. -Execute product-related activities, including apheresis material receipt, raw material disposition, production document issuance, batch review, and final product disposition and shipment. -Provide on-floor Quality Operations support for manufacturing, warehouse, and other technical operations, including in-process checks, deviation identification, and adherence to cGMP expectations.

Requirements

• cgmp
• bachelor’s
• cell therapy
• iso 7
• fmea
• capa

What You Bring

-Strong knowledge of cGMP regulations (21 CFR Parts 210, 211, 1271), and relevant ICH and FDA guidance. -Bachelor’s degree in a relevant scientific discipline with 5+ years of experience in the pharmaceutical or GMP industry. -Proficient in investigation tools and methodologies such as Fishbone diagrams, 5 Whys, and FMEA. -Experience in Quality Assurance oversight for manufacturing floors. -Excellent problem-solving skills with a focus on risk-based decision-making and continuous improvement. -Willingness to work in ISO 7 environments for on-the-floor QA support. -Proactive, adaptable, and committed to continuous learning. -CDMO experience is strongly preferred. -3+ years of cell therapy experience. -Demonstrated ability to lead and close complex quality investigations including root cause analysis and development of effective CAPAs. -Flexibility to travel between facilities and work varying hours, including evenings, weekends, and shifts as needed. -Proficient in ISO 7 gowning procedures. -Strong knowledge of batch record review, aseptic operations, and environmental monitoring. -5-7 years of QA experience in a GMP-regulated environment, ideally with cell therapy, gene therapy, or other advanced biologics. -Ability to understand technical concepts and make informed quality decisions in clinical manufacturing. -3-5 years of GMP manufacturing experience.

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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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