Quality Specialist I, Quality Systems

Job ID 2021-2177
Job Locations
US-GA-Union City
Category
Quality Assurance Mfg

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. Over communicate and seek feedback.
  • Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
  • Drive Results. Be accountable and execute – we win together when everyone perform.

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:  Responsible for monitoring policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and regulatory requirements. administrating corporate document control processes for all computerized and hard copy files. Responsible for adhering to GMP regulations, cGMP’s, c GDPs and company policies. Shift will be Monday - Friday - 9AM - 5PM

Responsibilities

  • Support the execution of Quality Systems policies and procedures;
  • Assists in compiling corporate and local, filing of documents and maintaining computerized files to support all documentation systems, including controlled documents, technical documents, master equipment, manufacturing, CMO, inspection readiness and other QMS areas as needed.
  • Assists the review and revision of procedures, specifications, protocols and forms.
  • Updates logs, databases and catalogues.
  • Generates Quality council support materials as needed.
  • Support the preparation of process and status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness.
  • May assist in executing and monitoring electronic document management systems and electronic change control systems
  • Assist with oversight of the change control, compliance and document control programs:
    • Draft, route and monitor change controls
    • Participate in CAPA activities as needed
    • Generate Quality Council support materials as needed.
    • Support the compliance area inspection readiness activities
  • 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, which require document control support and or change control support
  • Other duties as assigned within the Quality Systems Department

Qualifications

  • Bachelor’s degree in a scientific discipline or equivalent.
  • Proficient in MS Office applications.
  • 1-2 years related experience in cGMP/FDA regulated industry.
  • Knowledge of cGMPs
  • Attentive to details with excellent written & oral communications skills
  • Strong computer skills with Word, Excel and Access 

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

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed