TEMP Sr. Quality Specialist l, Manufacturing Quality

Dendreon Pharmaceuticals, LLC
Temporal Sr. Quality Specialist I – Manufacturing Quality

Seal Beach, CA

Job :  | # of Openings: 1 | Category:
Quality Assurance Mfg

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.

• 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.

The TEMP Sr. Quality Specialist I, Manufacturing Quality, will perform a wide variety of QA activities to ensure compliance with applicable regulatory requirements.

NOTE: This is a TEMPORARY role from May to December 2026 and will be ON‑SITE AT OUR SEAL BEACH, CA LOCATION
.

• 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 (authors/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 receives no instructions on routine work, general instructions on new assignments.

Education and Professional

Experience:

• 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).
• 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.

• 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 (–20 °C to 8 °C).
• 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.