Senior QA Specialist, Deviations

Location
Seattle, WA
Posted
Jun 20, 2022
Ref
REQ-05796
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time

Just is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of biological products. The ideal candidate will have significant experience in leading all Quality Assurance and batch disposition activities related to the manufacturing of biological products from Phase 1 to PPQ to commercial. Strong written and verbal communication skills, hands-on execution, and the ability to work with staff across multiple disciplines are essential to be successful in this position.

Responsibilities:

  • Manage the QA assessment, review, and approval of investigations of NC/CAPA/Change Control documentation.
  • Support internal and client audits of the quality management systems
  • Implement process performance and product quality monitoring programs
  • Continue to build and enhance various Quality Assurance programs
  • Alert senior management of significant quality, compliance, supply and safety risks

Educational Requirements:

  • Bachelors degree in biological or engineering science with 5+ years relevant experience

Preferred Qualifications:

  • Industry experience in a fast-paced growing company
  • Quality working experience with execution for Deviation / CAPA and Change Control
  • Critical thinker with a comprehensive understanding of biologics regulatory requirements, risk management principles, and science-based decision making
  • Expertise in tools, concepts, and methodologies of QA
  • Strong computer skills including Microsoft Office and eQMS databases, including LIMS, CMMS, MES
  • Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and building teams


Worker