Full-Time

QA Validation Manager

QC Equipment and Instruments

Updated on 5/21/2024

AbCellera Biologics

AbCellera Biologics

501-1,000 employees

Develops antibody-based medicines and technologies

AI & Machine Learning
Data & Analytics
Biotechnology

Senior

Vancouver, BC, Canada

Required Skills
Quality Assurance (QA)
Google Cloud Platform
Requirements
  • BS, BA, or equivalent degree in Sciences or Engineering
  • 8+ years Biotech/Pharmaceutical with Quality Compliance or QA Validation experience
  • Familiarity with GCP, GMP, GDP, and GLP
  • Proficiency in ISPE Baseline Guide Vol 5 and GAMP 5
  • Strong grasp of relevant standards: USP, ANSI, ISO, ASTM, OHSA
  • Knowledgeable about data governance and integrity regulations
  • Experience in creating, reviewing, and approving validation documents
  • Skilled in strategic thinking and risk-based decision-making
  • Excellent oral and written communication skills
  • Expertise in CQV for various QC instruments and equipment
Responsibilities
  • Leading, managing, and developing the QA Validation team for QC instruments
  • Establishing and maintaining quality validation processes to meet regulations
  • Collaborating with instrument vendors for validation and troubleshooting
  • Drafting essential QC validation documents and supporting CQV projects
  • Reviewing and approving commissioning and qualification documents
  • Assisting in post-qualification procedures like calibration and maintenance
  • Ensuring clarity and defensibility of approved validation documents
  • Addressing validation-related investigations and implementing actions
  • Representing QA/QC validation in interactions with health authorities
  • Driving continuous improvement and goal-setting for new programs
  • Collaborating across functions to resolve issues effectively and interfacing with external partners and regulators as needed

AbCellera distinguishes itself as an exemplary workplace within the biotechnology sector by expertly merging advanced technology and data science with an integrated team of experts. This strategic amalgamation not only speeds up the development of antibody-based medicines but also fosters an environment that is at the cutting edge of therapeutic innovation. By working here, one can directly contribute to solving complex challenges in drug development, benefiting from a collaborative culture that emphasizes efficiency and breakthroughs in healthcare solutions.

Company Stage

Series A

Total Funding

$393.1M

Headquarters

Vancouver, Canada

Founded

2012

Growth & Insights
Headcount

6 month growth

-4%

1 year growth

13%

2 year growth

75%