TEMP Sr Quality Specialist I, Manufacturing Quality

Company Overview At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleuc‑T), was the first FDA‑approved immunotherapy for metastatic castrate‑resistant prostate cancer, utilizing a patient’s own immune cells to fight the disease. If you’re driven by the opportunity to make a meaningful impact on cancer patients’ lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation. Core Values Put Patients First: Every day is an opportunity to improve the lives of those living with cancer. Act with Integrity: We commit to transparency, honesty, and always doing what’s right. Build Trust: Trust is earned through candid, open communication and a collaborative approach. Raise the Bar: We embrace continuous improvement and innovation, always striving to elevate our people. Drive Results: We are accountable to each other and deliver success together. Job Summary The Sr. Quality Specialist I, Manufacturing Quality, will perform a wide variety of QA activities to ensure compliance with applicable regulatory requirements. This is a TEMPORARY role from May to December 2026 and will be on-site at our Seal Beach, CA location. Responsibilities Perform activities related to batch record process flow (i.e. Issuance, Review, Closure). Perform incoming receipt of patient material and packing of Final Product. Perform Final Product disposition and release. Perform Raw Material review and approval. Review and approve GMP facility work orders. Review and approve system, equipment or method validation protocols, reports, and related validation documents (e.g., Requalification, URS, FRS, RBRAs, etc.). Conduct product complaint investigations. Process deviations and non‑conformances. Track/trend metrics and reports data to Senior Management for escalation as necessary. Process change controls (author/review change impact and risk assessments). Provide support for any other duties assigned. Represent department in cross‑functional teams, projects and GXP‑related problem resolution. Use professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways. Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receive no instructions on routine work, and general instructions on new assignments. Qualifications Bachelor’s degree in a scientific discipline or equivalent. 7+ years in a cGMP regulated environment with related experience within the biopharmaceutical or biotechnology industry preferred. 10+ years of relevant work experience can be substituted for a 4‑year course of study leading to a Bachelor’s degree. Knowledge of current regulatory requirements in support of cGMP manufacturing operations (e.g., FDA and ICH guidelines). Experience in knowledge of sterile products aseptic manufacturing processes and testing preferred. Understanding of facility/building related knowledge (ISO classifications, air handling units, differential pressures). Proficient in MS Office applications. Ability to gown aseptically for work in Clean Room environments. Working Conditions And Physical Requirements Limited use of laboratory equipment, chemicals and biological materials. Ability to sit or stand for extended periods of time. Intermittent walking to gain access to work areas. Finger dexterity sufficient to use a computer and to complete paperwork activities. Vision sufficient to use a computer, to read written materials and to complete paperwork activities. Hearing sufficient to communicate with individuals by telephone and in person. Ability to lift up to 25 pounds. Limited exposure to (2C – 8C); (-20C). Job performed in a lab, office, or utility (noisy) environment. Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials. #J-18808-Ljbffr Dendreon