<p>Job Title: Quality Specialist</p> <p>Job Description</p> <p>Join our team as a Quality Specialist, where you will play a vital role in ensuring compliance with quality objectives and regulatory requirements within a dynamic and innovative environment.</p> <p>Responsibilities</p> <ul> <li>Provide on-floor Quality Operations support for manufacturing, warehouse, and technical operations, including in-process checks and deviation identification. </li><li>Ensure all manufacturing activities comply with GMP and regulatory requirements. </li><li>Review and approve GMP documentation for accuracy and compliance. </li><li>Execute product-related activities, including apheresis material receipt and final product disposition. </li><li>Lead investigations into deviations, non-conformances, and process anomalies. </li><li>Review and approve deviations and CAPAs, ensuring compliant resolution. </li><li>Collaborate cross-functionally with Manufacturing, Quality Control, and Supply Chain teams. </li><li>Support continuous improvement initiatives to enhance quality and compliance. </li><li>Participate in internal audits and regulatory inspections. </li><li>Perform additional duties to support departmental goals. </li></ul> <p>Essential Skills</p> <ul> <li>3+ years of cell therapy experience. </li><li>3-5 years of GMP manufacturing experience. </li><li>Quality Assurance oversight for manufacturing floors. </li><li>Experience with ISO 7 gowning. </li><li>Technical and growth mindset. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Bachelor's degree in a relevant scientific discipline. </li><li>5+ years of experience in the pharmaceutical or GMP industry. </li><li>Strong knowledge of batch record review, aseptic operations, and cGMP regulations. </li><li>Proficient in investigation tools like Fishbone diagrams, 5 Whys, and FMEA. </li><li>Ability to lead and close complex quality investigations. </li><li>Willingness to work in ISO 7 environments. </li><li>Flexibility to travel between facilities and work varying hours. </li></ul> <p>Work Environment</p> <p>Be part of a growing CDMO specializing in Cell/Gene Therapy at a brand-new site. The work environment involves engaging with innovative technologies and maintaining a commitment to operational excellence. Flexibility in working hours, including evenings and weekends, is required. Expect a collaborative atmosphere that encourages continuous learning and problem-solving.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $75000.00 - $85000.00/yr.</p> <p>401k medical dental vision</p> <p>Workplace Type</p> <p>This is a fully onsite position in Princeton,NJ.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Jul 28, 2025.</p> <p>About Actalent</p> <p>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.</p> <p>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.</p> <p>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 actalentaccommodation@actalentservices.com for other accommodation options.</p>