TEMP Sr. Quality Specialist l, Manufacturing Quality

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.

• →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 life 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.