Product Release Qa Specialist Jobs in British Columbia

Extensive knowledge of Quality System regulatory requirements, including 21 CFR 820, 21 CFR 210 and 211

Bachelor's degree in a related field, with a minimum of six years of experience within a regulated environment

GMP experience in biotechnology, pharmaceutical or life science field is a must

Thorough understanding of regulatory, corporate, and customer requirements

Ability to prioritize, manage, and coordinate tasks in a dynamic environment

Review, verify and process of QMS records to ensure compliance to QMS standards such as ISO 9001/13485/relevant GMPs, and established procedures

Work closely with Developers, QA, Product Managers, and others to understand new features, use cases, and customer scenarios.

4+ years of software testing experience.

Working experience on Virtual machine environment, i.e VMware / ESXi, Hypervisor

Demonstrated knowledge of firewalls, Linux, Sniff, or Ethereal

Strong knowledge of IPSec, SSL VPN, data encryption and authentication

Knowledge of general QA procedures and methodologies, as well as software development fundamentals.

Experience in vendor qualification and audit.

Develop processes and procedures for the quality department, under the guidance of the QA Manager.

B.Sc in the life sciences degree; including pharmacy, chemistry or other equivalent qualification if preferred.

4-6 years of experience in a GMP or equivalent regulated environment

Training and experience in documentation control, change control, CAPAs and review of quality records.

Ability to work independently and possess excellent organizational skills.