Quality Specialist I, Quality Systems

Dendreon Pharmaceuticals•Union City, GA

About The Position

Overview 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 Dendreon is seeking a highly motivated individual as a Quality Specialist I, Quality Systems. This is an excellent opportunity for someone to participate in a fast-paced high volume production environment with high quality and regulatory standards. Efficiency, accuracy and excellent communication skills are essential to success in this position.

Requirements

Bachelor’s degree in science, engineering or equivalent experience.
1 year related experience in quality assurance, quality control, compliance, or manufacturing of commercial or clinical pharmaceutical or biotechnology derived parenteral and/or cellular therapies preferred.
Knowledge of cGMPs.
Attentive to details with excellent written & oral communications skills.
Strong computer skills with Word, Excel and Access.

Responsibilities

Support the maintenance of Quality Systems policies and procedures.
Assist with oversight of the deviation/CAPA programs:
Provide input and quality oversight over investigations
Review and approve deviations and CAPAs
Assist with tracking and trending Quality System metrics
Conduct timely Quality review of associated data, including data utilized to support lot release, to meet business and operations requirements, and to ensure data meets the industry requirements for data integrity.
Ensure that procedures are being followed as outlined under FDA and the Quality System requirements.
Represents department in cross-functional teams, projects and GXP-related problem resolution.
Provides guidance in one or more of the following:
Review and approval of change controls
Investigation and recall of non-conforming materials
Investigations associated with product failures, product complaints and BPDRs
Support FDA/Regulatory Agency inspections