Job Title: Quality Assurance SpecialistJob Description We are seeking a dedicated Quality Assurance Specialist to manage and investigate product quality complaints. The role involves documenting complaints, supporting investigations, ensuring compliance with regulatory requirements, and maintaining high-quality standards in adherence to Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs). The specialist will also perform data analysis, manage product complaint samples, and support corrective and preventive actions (CAPA). Responsibilities + Receive product quality complaints. + Document complaints in the Quality System and triage safety events to the appropriate department. + Support product quality complaint investigations. + Ensure compliance with applicable regulatory requirements. + Maintain programs and processes to ensure high-quality products and GMP/GLP compliance. + Perform data analysis to support complaint investigations and quarterly trend analysis. + Assist lead/coordinator with investigations and CAPA relating to manufactured products. + Manage product complaint samples from receipt through destruction. + Follow general instructions on routine work and detailed instructions on new assignments. Essential Skills + Experience with deviations and investigations in the pharmaceutical or biotech industry. + Ability to write deviations on pharma/biotech product complaints. + Critical thinking skills to ask questions and dig deeper into issues. + Experience working with cross-functional teams and Contract Manufacturing Organizations (CMOs), primarily via email. + Quality assurance expertise. Additional Skills & Qualifications + 2-4 years of experience in the pharmaceutical or biotech industry. + Bachelor's degree in a scientific field. + Preferred experience with Oral Solid Dosage (OSD) or biologics; medical device experience is acceptable. + 4+ years of experience preferred for QA Spec II level. Work Environment This role offers a hybrid work environment with onsite work required on Tuesday, Wednesday, and Thursday, and the option to work from home on Monday and Friday. 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people 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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.