Quality Control Associate II, Stability

US-WA-Seattle
Job ID
2017-1065
Category
Quality Control

Overview

Quality Control Associate II, Stability is accountable for supporting the management of the antigen stability program objectives, including data generation, data review, preparation of data tables, data trending and reporting to regulatory agencies, in accordance with appropriate regulatory, corporate and scientific guidelines.  Accountable for performing QC activities related to CMO’s, including CoA issuance, product specifications, change controls, and investigations.

Responsibilities

  • Plan, organize and manage daily activities for the stability program, including study set up and sample management.
  • Generate, review and trend stability data tested internally and at CMO’s.
  • Prepare stability sections for regulatory submissions (BLA, IND, etc.).
  • Performs regular maintenance of QC equipment.
  • Author stability protocols and reports.
  • Provide technical support during release testing at contract manufacturing/testing (CMO) organizations.
  • Prepare Certificates of Analysis (CoA) for CMO products and materials.
  • Authors, revises, and reviews Dendreon and CMO SOP’s, product specifications, and investigations.
  • Participate on project teams representing the Quality Control (QC) department.
  • Work closely with internal departments, including Quality Assurance, Contract Manufacturing, Development, and Process Engineering.
  • Adheres to good documentation practices to ensure data integrity and traceability.
  • Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.

Qualifications

  • Bachelor’s degree in a scientific discipline or equivalent.
  • Typically 5+ years related experience in cGMP/FDA regulated industry.
  • Intermediate level of analysis skills required to evaluate and interpret data to arrive at logical conclusions. Understanding on how to apply, and/or experience with, problem solving tools (i.e. Fishbone diagram, IS/IS NOT, Kepnoe/Trego concept, 5Ms and 5 Whys)
  • Knowledge of cGMP/QSR/ICH, FDA stability guidelines and FDA device/drug/biologics regulations preferred.
  • Strong knowledge of and/or hands-on experience with the following methodologies: HPLC, UV Spectrophotometry, bioassays, ELISA, SDS-PAGE, and peptide mapping, cell culture.
  • Ability to prioritize and successfully manage complex and competing projects.
  • Attention to detail, quality and compliance.
  • Proficient in MS Office applications.
  • Excellent oral and written communication skills.

Options

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