QA Generalist

Overview

Ensure biotech product quality, compliance, and support technical transfers.

Key Responsibilities

• audit resolution
• batch review
• document control
• regulatory filings
• qms implementation
• metrics compilation

Tasks

-Address and resolve audit findings, ensuring corrective actions are implemented. -Perform batch record review and release in support of US and ex-US clinical trials. -Support the management of document control processes, including reviewing and approving batch records, deviation reports, and change controls. -Collaborate with CDMOs and internal CMC teams to ensure quality standards are met from development through commercialization. -Assist in the preparation of regulatory filings and submissions. -Assist in the creation and maintenance of SOPs, policies, and associated documents. -Compile metrics for internal and external operations. -Support in the execution of internal audits to ensure compliance with regulatory standards. -Provide Quality support to CMC throughout the product lifecycle. -Investigate and address product quality issues, including deviations, OOS results, and non-conformances. -Assist in preparing for internal and external audits. -Review and approve technical transfer documents including protocols, reports, master batch records, and test methods. -Ensure that all documentation is accurate, complete, and compliant with internal policies, procedures, and regulatory standards. -Implement, maintain, and improve the Quality Management System (QMS) in accordance with internal policies, procedures, regulatory requirements, and industry standards.

Requirements

• quality assurance
• gmp
• capa
• technical transfer
• life sciences
• leadership

What You Bring

-Effective presentation and writing skills. -Significant experience in drug manufacturing or biologics industry in Quality Assurance, Quality Control, or Quality Engineering position. -Experience in a startup early phase-late phase setting is highly desirable. -Experience with audit processes, document control, and Quality Management Systems: deviations, change control management, and CAPAs. -Experience in cell and gene therapy. -Minimum of 4 years’ experience in biopharmaceutical operations, technical operations, and/or quality operations, with 2+ years hands-on experience in Quality function supporting clinical or commercial lifecycle management. -Experience supporting product technical transfer activities and comparability studies. -Strong interpersonal and leadership skills with the ability to build and maintain effective professional relationships. -Demonstrated knowledge of Quality Management Systems, preferably electronic systems. -Extensive knowledge of GMP, GCP ICH, and US/EU/UK regulations. -Ability to provide clear, pragmatic direction and advice regarding compliance issues. -Bachelor's Degree in Life Sciences (Biology, Biochemistry, Biotechnology, etc.) or a related field. -Must be highly organized and able to work collaboratively with a team.

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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 -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Short and long-term disability -Time Off/Leave (PTO, Vacation or Sick Leave) -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