QA Generalist

Job Title: QA Generalist, CMC Top Skills' Details • biotechnology technical transfer experience (cell therapy desired) • process characterization experience • batch record review experience MUST HAVE CELL THERAPY BACKGROUND Job Description The QA Generalist, CMC is a key member of the Quality & Compliance team, reporting to the Senior Manager, CMC Quality. This role is crucial in maintaining high-quality standards in alignment with applicable laws, regulations, policies, and procedures. The QA Generalist will support quality assurance processes, ensure compliance with regulatory standards, and collaborate with cross-functional teams to uphold product integrity and safety. This position requires a strong understanding of both laboratory and manufacturing environments within the biotechnology industry. Responsibilities • Perform batch record review and release in support of US and ex-US clinical trials. • Investigate and address product quality issues, including deviations, OOS results, and non-conformances. • Collaborate with CDMOs and internal CMC teams to ensure quality standards are met from development through commercialization. • Provide Quality support to CMC throughout the product lifecycle. • Review and approve technical transfer documents including protocols, reports, master batch records, and test methods. • Implement, maintain, and improve the Quality Management System (QMS) in accordance with internal policies and procedures, regulatory requirements, and industry standards. • Assist in the creation and maintenance of SOPs, policies, and associated documents. • Compile metrics for internal and external operations. • Support the management of document control processes, including reviewing and approving batch records, deviation reports, and change controls. • Ensure that all documentation is accurate, complete, and compliant with internal policies and procedures and regulatory standards. • Assist in preparing for internal and external audits. • Support in the execution of internal audits to ensure compliance with regulatory standards. • Address and resolve audit findings, ensuring corrective actions are implemented. • Assist in the preparation of regulatory filings and submissions. Essential Skills • Extensive knowledge of GMP, GCP, ICH, and US/EU/UK regulations. • Cell and gene therapy experience preferred. • Experience supporting product technical transfer activities and comparability studies. • Significant experience in drug manufacturing or the biologics industry in Quality Assurance, Quality Control, or Quality Engineering positions. • Demonstrated knowledge of Quality Management Systems, preferably electronic systems. • 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 with audit processes, document control, and Quality Management Systems: deviations, change control management, and CAPAs. • Strong interpersonal and leadership skills with the ability to build and maintain effective professional relationships. • Effective presentation and writing skills. • Ability to provide clear, pragmatic direction and advice regarding compliance issues. • Must be highly organized and able to work collaboratively with a team orientation and passion for continuous self-development. Additional Skills & Qualifications • Bachelor's Degree in Life Sciences (Biology, Biochemistry, Biotechnology, etc.) or a related field. • Experience in a startup early phase-late phase setting highly desirable. Work Environment • Flexible working hours, primarily first shift with remote work options. • Collaborative team environment working with a manager and director within QMS. • Opportunity to work with a biotech company progressing towards pivotal trials. • Leadership stability with the same team for over 8 years. • Comprehensive benefits including accrued PTO, holiday pay, and sick pay. Pay and Benefits The pay range for this position is $35.00 - $50.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on May 13, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] for other accommodation options. Apply tot his job