Quality Specialist I, Quality Systems

Who we are.

Dendreon is making the battle against cancer personal. Founded on the belief that the immune system holds the key to the future of cancer care, Dendreon is committed to the delivery of treatments that harness the power of the body’s immune system to attack cancer cells.

If you are looking to positively impact the lives of patients, we want you to join our team. Headquartered in Seal Beach, California, and with sizable locations in Union City (Greater Atlanta), Georgia and Seattle, Washington, as well as countrywide Commercial and Medical Science Liaisons teams, we have a diverse offering of exciting opportunities.

What we do.

Vision – Pioneering the future of immunotherapy.

Mission – Making the battle against cancer personal through immunotherapy treatments that extend lives.

How we do it.

The Dendreon Way.  We are a purpose-driven, value-based culture. At Dendreon, we…

• 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. 
• Raise the Bar:  Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win when everyone performs.

Primed for Growth - Contract/Partner Manufacturing Business Unit 

Dendreon has been working in the cellular immunotherapy space for over 10 years and brings all the experiences that comes with developing a complex manufacturing process from clinical development through to consistent commercial production. Dendreon is unmatched in its patient logistics/operational functions, manufacturing excellence in cellular therapies and commercial sales team for cellular immunotherapies. Given this expertise, we plan to leverage these strengths to grow Dendreon's pipeline of products initially through contract manufacturing for partners and then patient operations and eventually commercial sales.

Are you ready?

Our high-performing organization challenges, develops, and rewards employees interested in pushing past typical career limitations. If you are passionate about helping patients and looking for a unique career opportunity, view our open positions to apply or refer a friend today.

Job Summary

The Quality Specialist I, Quality Systems supports the administration and maintenance of Quality Systems within a cGMP-regulated environment. This role is responsible for assisting with quality processes, including deviations, CAPA, document control, and data review, to ensure compliance with internal procedures and applicable regulatory requirements. The position works cross-functionally to support quality operations, maintain data integrity, and contribute to inspection readiness and continuous improvement initiatives. This role is onsite at our Union City, GA location.

• Support the maintenance and continuous improvement of Quality Systems, including policies, procedures, and records.
• Assist in the administration of deviation and CAPA programs, including:
• Supporting investigation activities and documentation.
• Performing initial reviews of deviations and CAPAs for completeness and compliance.
• Tracking, trending, and reporting Quality System metrics.
• Perform Quality review of documentation and data, including records supporting lot release, to ensure accuracy, completeness, and compliance with data integrity standards (ALCOA+).
• Support document control processes, including creation, revision, and archival of SOPs and controlled documents.
• Collaborate cross-functionally to support GxP investigations, change controls, and quality-related initiatives.
• Assist with product complaints, nonconformance investigations, and regulatory reporting (e.g., BPDRs), as applicable.
• Support internal audits, regulatory inspections, and audit readiness activities.
• Ensure adherence to cGMP requirements and internal procedures across operations.
• Utilize electronic Quality Management Systems (eQMS) to manage quality records and workflows.

Required Experience & Education

• Bachelor’s degree in science, engineering, or related field.
• 1-3 years of experience in quality assurance, quality systems, manufacturing, or compliance in a regulated pharmaceutical or biotechnology environment.
• Basic knowledge of cGMP regulations and FDA requirements.
• Strong attention to detail with effective written and verbal communication skills.
• Proficiency in Microsoft Office applications (Word, Excel, Outlook)

Preferred Experience

• Experience with Quality Systems processes (deviations, CAPA, change control, document control)
• Familiarity with electronic QMS platforms (e.g., TrackWise, Veeva)
• Understanding of data integrity principles (ALCOA+)
• Experience in biologics, cell therapy, or sterile manufacturing environments

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. Lift up to 50 lbs.
• May be required to work alternate shifts.