Sr. Quality Specialist

Dendreon
Posted

Post Expires

Type

Executive / senior industry position

 

Overview

The Senior Quality Specialist, Validation participates in the development, implementation and adherence to validation of product processes, test procedures (equipment, utilities, and cleaning), and information systems to ensure validation activities meet appropriate regulatory agency requirements, internal company standards and current industry practices.

Responsibilities

Responsibilities:

  • Responsible for validation projects through the development of validation schedules, master plans, validation protocols and reports for process, equipment, cleanrooms, utility systems, facilities to support clinical and commercial manufacturing.
  • Coordinates validation activities with, and seeks team supportsfrom Manufacturing, Facilities, Quality Control, third Parties, and other groups on validation projects
  • Writes/Reviews/Approves/Executes validation protocols and reports supporting the validation of equipment, systems and processes
  • Provides general support to meet department goals and objectives
  • Provides validation Risk Assessment, performs NC investigations, and supports Change Controland/or CAPA activities
  • Mentors new team members and assists in the training of validation execution
  • Supports regulatory inspections or audits
  • Serves as information resource for validation technicians, contractors and vendors
  • Represents department in cross-functional teams, projects and GXP related issues
  • Reports/presents status and progress of validation activities or projects to the Leadership team
  • Performs other Quality Assurance duties as assigned

 

  • Ability to think critically with demonstrated troubleshooting and problem-solving skills;
  • Excellent interpersonal, verbal and written communication skills are essential in our collaborative work environment
  • Comfortable in a fast-paced small company environment and able to adjust workload based on changing priorities and business needs.

Qualifications

  • 8 years of relevant validation experience in a pharmaceutical/cGMP environment.
  • Ability to perform validation activities for equipment and computer-related validation (test) protocols
  • Working knowledge of FDA cGXP/ICH US regulations related to validation activity is required

Options

Share on your newsfeed Dendreon is an Equal Employment Opportunity F/M/Disability/Vet/Sexual Orientation/Gender Identity / Affirmative Action employer and provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures. If you have any difficulty using our online system and you need an accommodation due to a disability, you may use the alternative email address below to contact us about your interest in employment at careers@dendreon.com, or you can send your resume to Angalisa.savala@dendreon.com or you can call us at +1-562-252-7500.

More Information

Posted

Post Expires

Type

Executive / senior industry position

Seal%20Beach%2C%20United%20States

Seal Beach , United States