QA Administrator — Records, CAPA & Training

Run my Accounts AG; Edmonton; On-site; CAD 70,000 - 100,000; Full time

Benefits offered by this job

Comprehensive Health Coverage

RRSP Matching

Professional Development Opportunities

Generous PTO

Job summary

Applied Pharmaceutical Innovation (API) invites applications for an Administrator, Quality Assurance role based in Edmonton. The position supports QA activities, including document management, training, and quality systems tasks, with a strong emphasis on change control, risk assessment, and CAPA processes.

This full-time, on-site role requires ensuring GMP compliance, participating in audits, and collaborating with cross-functional teams to sustain data integrity and robust QA operations.

Qualifications

• Bachelor's degree in engineering and/or IT, life sciences, or related field.
• 3+ years of QA experience in pharmaceutical/medical device.
• Experience with Health Canada and FDA cGMP requirements incl. 21 CFR Part 11, 210 & 211, EU Annex 11, ICH Q7 and internal API procedural requirements.
• Experience in electronic quality management systems (QMS) and QMS product management.
• Ability to drive requirements to closure and educate colleagues on data integrity (ALCOA+).
• Demonstrated analytical and conceptual problem-solving skills with ability to communicate complex findings.

Responsibilities

• Perform deviation investigations and CAPA implementations.
• Lead root cause analysis and determine most probable root causes.
• Maintain QA compliance with regulatory standards.
• Support document control and change controls processes.

Skills

QA experience

CAPA

QMS

GMP

Root cause

Education

Bachelor's degree in engineering

Life sciences degree

Tools

eQMS

Job description

Applied Pharmaceutical Innovation (API) invites applications for an Administrator, Quality Assurance role based in Edmonton. The position supports QA activities, including document management, training, and quality systems tasks, with a strong emphasis on change control, risk assessment, and CAPA processes.

This full-time, on-site role requires ensuring GMP compliance, participating in audits, and collaborating with cross-functional teams to sustain data integrity and robust QA operations.