TEMP Sr Quality Specialist I, Quality Assurance

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 Senior Quality Specialist I, Quality Assurance supports site Manufacturing Quality Assurance

(MQA). This role performs and may lead a wide variety of QA activities that align with policies,

processes, procedures, and controls 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.
• Perform issuance of controlled labels and associated forms.
• Supports investigation and recall of nonconforming materials.
• Review and approve GMP facility work orders and validation activities.
• Draft Biological Product Deviation Reports (BPDRs) for post distribution nonconformances.
• Assist with tracking, trending, and preparation of Quality metrics including the Annual Product Review.
• Author and review documents (i.e. Standard Operating Procedures; Reports).
• Provide training and assist with the training program, as needed.
• Provide guidance to other Quality Assurance personnel and quality partners.
• Initiate, assist with oversight of, and perform investigations for nonconformances and Corrective Actions and Preventive Actions (CAPAs).
• Support change control and/or CAPA activities, as needed.
• Participate in internal audits as subject matter expert (SME), as needed.
• Serve as the lead in the absence of the supervisor.
• Provide support for any other duties as assigned.

Key Responsibilities:

• Demonstrate interpersonal effectiveness skills.
• Demonstrate analytical and systematic problem-solving skills.
• Demonstrate competent communication to effectively.
• Interact with regulatory authorities.
• Provide knowledge/technology transfer for applicable quality systems.
• Communicate to management and the group with clarity, brevity, and accuracy.
• Ensure work is in compliance with required regulatory standards and conforms to company policies and Standard Operating Procedures (SOPs).
• Perform changes to policies and establishes procedures that affect immediate organization(s).
• Provide timely quality support to stakeholders.
• Demonstrate strong skilled planning and organizing, and relationship building.
• Collaborate with cross-functional teams and partners.
• Implement process and program improvement changes.
• Ensure compliance with safety, health, environmental and cGMP and other applicable regulations.
• Establish positive relationships and interfacing with internal, multi-functional departments.
• Notify senior management regarding quality issues as required by site procedures for escalation and prepares reports as requested.
• Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
• Follows policies and procedures in selecting approaches and techniques to obtaining solutions.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Works independently with little to no instruction on routine work, general instructions on new assignments.
• Some travel may be required.

Required Experience & Education:

• BS in Life Sciences or other relevant scientific discipline
• 7+ years in a cGMP regulated environment with related experience within the biopharmaceutical or biotechnology industry preferred.
• Advanced 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.
• Exceptional attention to detail.
• High energy, motivated self-starter.
• Excellent interpersonal skills (i.e. communication) to interface effectively with all levels of colleagues in a team environment, and with vendors, contractors and external customers, as applicable.
• Ability to use professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
• Solve problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Excellent and demonstrated organizational skills related to priorities and workload that have proven results in the ability to be self-directed while managing multiple projects.
• Ability to collaborate and foster internal teamwork with other cross-functional areas and sites.
• Ability to work and make decisions independently and have the flexibility to adapt to changing priorities.
• Ability to lead quality projects, as needed.
• Demonstrate and maintain the highest standards of ethical behavior.
• Ability to drive results through independent assignments or team assigned orientated tasks and responsibilities.
• Ability to network, share best practices and further develop skill level.
• Ability to manage multiple priorities and tasks in a fast pace, dynamic environment.
• Work well under pressure with an ability to meet tight deadlines.
• Ability to exercise good judgment.
• Demonstrated knowledge of cGMP.
• Ability to use computer programs.

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.