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Quality Assurance Associate

Full-Time Alberta, Canada
Health & Biotech
Health & Biotech
30 October 2024
Description
  • Performs Quality Assurance tasks that supports GMP-compliant operations in an API manufacturing facility.
  • Drafts technical documents, such as specifications and operating instructions, based upon information provided by other departments, standard procedures, and quality requirements.
  • Performs detailed reviews of documentation related to GMP activities.
  • Routes, tracks and completes documents in the electronic document systems and ensures that entries are accurate and current.
  • Updates and maintains various databases as needed. Assists with the issuance and maintenance of controlled documents.
  • Types, scans/copies, distributes/retrieves, and files controlled documents and records as required.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
  • Participates in continuous improvement initiatives based on international regulations and industry best practices.
  • Prioritizing tasks to ensure the critical tasks are completed on time and meet requirements.
  • Participates in site inspection readiness and the site internal audit program, including site walkthroughs.
Qualifications
  • A BS or BA degree in a scientific area or a high school diploma and minimum 3 years of relevant experience.
  • Must be able to think critically and creatively, be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills.
  • Demonstrates excellent communication (verbal and technical writing) skills and strong interpersonal skills.

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