Quality Specialist I, Quality Systems

Who We Are:

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.

Core Values:

• 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.

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.