Quality Specialist I, Supplier Quality - Dendreon Corporation

Who we are.

Dendreon is making the battle against cancer personal. Our flagship product PROVENGE^® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.

If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Core Values:

• Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer
• Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
• Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
• Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win together when everyone performs

Job Summary: Dendreon seeks a Quality Specialist I, Supplier Quality that is responsible for raw material inspection to ensure compliance with applicable regulatory requirements.

Your Work:

• Plans, organizes, provides oversight of, and performs raw material testing, including contract testing laboratories, vendors and warehousing.
• Communicates with Quality Assurance and Materials Management departments to ensure on-time delivery of test results and issuance of CoA.
• Ensures raw material standard operating procedures are kept-up-to-date with manufacturer’s operating manuals and recommendations.
• Responsible for the revision of material specifications.
• Participates in non-conformance investigations providing technical expertise and guidance during material investigations associated with raw materials.
• Provides technical expertise and testing support to other departments as part of cross-functional project teams.
• Supports raw material activities such as sample and reagent management.

Education Requirements:

• Bachelor’s degree in a scientific discipline or equivalent.

Job Requirements:

• Typically, 1 year related experience in cGMP/FDA regulated industry.
• Experience with raw material testing and release preferred.
• Experience with ANSI sampling and inspection methodology preferred.
• Knowledge of cGMP/QSR and FDA device/drug/biologics regulations.
• Proficient in MS Office applications

Working Conditions and Physical Requirements:

• 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 (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
• May be required to work alternate shifts
• Ability to gown aseptically for work in Clean Room environments
• 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.