TEMP Sr Quality Specialist I, Quality Assurance

Dendreon Corporation•Seal Beach, CA

About The Position

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. 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.

Requirements

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.
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.

Nice To Haves

Experience in knowledge of sterile products aseptic manufacturing processes and testing preferred.

Responsibilities

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.