TEMP Sr. Quality Specialist l, Manufacturing Quality
About The Position
At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleucel-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. This is a TEMPORARY role from May to December 2026 and will be on-site at our Seal Beach, CA location.
Requirements
- 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 (i.e., FDA and ICH guidelines).
- Proficient in MS Office applications.
- Ability to gown aseptically for work in Clean Room environments.
Nice To Haves
- 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.
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 (ie. Requalification, URS, FRS, RBRAs etc).
- Conduct product complaint investigations.
- Processes deviations and non-conformances.
- Track/trend metrics and reports data to Senior Management for escalation as necessary.
- Processes change controls (authors/review change impact and risk assessments).
- Provide support for any other duties assigned.
- Represents department in cross-functional teams, projects and GXP-related problem resolution.
- Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
- Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Normally receives no instructions on routine work, general instructions on new assignments.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
