Quality Specialist I, Quality Systems

Dendreon Corporation•Union City, GA

About The Position

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.
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.

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