Quality Assurance Associate

Résumé du poste

The Quality Assurance Associate will review batch records, SOPs, and analytical data while supporting internal and external audits. They will also participate in investigations, deviations, and CAPA processes to ensure compliance with GMP standards.

Détails du poste

At Providence Therapeutics, we Ignite the Cure Within. We are a clinical stage Canadian mRNA company focusing on getting the best quality vaccines to the places that need it most. These include infectious diseases and cancer. We are on the leading edge of vaccine development and are on the hunt for people with an adventurous mindset to join us. We want to make a difference and help heal the World. We have an immediate opening for a Quality Assurance Associate. This position is available in Calgary, AB. How we plan on keeping you busy: * Review master and executed batch records, SOPs, STMs, Protocols, Reports, Qualification and validation documents, Analytical data including raw data, ELN, COAs. * Author and review QA documents. * Review external vendors GMP documents. * Support internal and external audit preparation, including document collation, checklist preparation, and follow-up on audit observations. * Participate in investigations, deviations, CAPA, and change control tracking, ensuring timely follow-up and closure support. * Perform Line clearance and environmental monitoring activities. * Support maintenance and improvement of the Quality Management System (QMS) in alignment with GMP and internal quality standards. * Assist in document control activities, including formatting, review coordination, version control, and archival of SOPs, policies, and records. * Help perform quality data trending and analysis (e.g., deviations, complaints, CAPAs) to identify recurring issues and improvement opportunities. * Assist in training coordination, maintaining training records, and tracking completion in the learning management system. What will help you get here: * Bachelor or Master degree in discipline related to biologic or pharmaceuticals (biochemistry, biology, chemistry, medical sciences, molecular biology, or relevant field). * 2–5 years of experience in pharmaceutical/biotechnology QA. * Knowledge of GMP, GLP, GDP, and regulatory requirements. * Familiarity with FDA, EMA, Health Canada, and other health authority guidelines is an asset. * Familiar with standard analytical lab practices and techniques. * Strong background and interest in molecular biology, biochemistry, and chemistry. * Strong computer skills: Microsoft Excel, Word, PowerPoint. Knowledge of data analysis techniques is a strong asset. * Strong verbal and written communication and presentation skills. * Strong analytical and problem-solving skills. * Ability to work independently and as part of a team. What its like to work with us: At Providence Therapeutics, you’ll be working with a clinical Canadian Biotech company that is innovating in the fast-growing mRNA space. We are focused on helping and healing people around the world. We are looking for culture builders and visionaries to help us make our infectious disease and cancer programs a reality. You truly have an opportunity to have a positive impact on individuals’ lives. What you can expect working with us: * Competitive salary and flexible benefits package * Flexible and remote work * Unlimited vacation and Providence Wellness Days

Ce que vous ferez

The Quality Assurance Associate will review batch records, SOPs, and analytical data while supporting internal and external audits. They will also participate in investigations, deviations, and CAPA processes to ensure compliance with GMP standards.

Exigences

Candidates must hold a Bachelor or Master degree in a relevant biological or pharmaceutical field. A minimum of 2–5 years of experience in pharmaceutical or biotechnology QA is required, along with strong knowledge of GMP and regulatory guidelines.

Avantages

• Competitive salary • Flexible benefits package • Flexible work • Remote work • Unlimited vacation • Providence Wellness Days

Compétences indiquées

• Assurance qualité · Souhaitée
• Regulatory Compliance · Souhaitée
• Analyse de données · Souhaitée
• Microsoft Excel · Souhaitée
• Communication Skills · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Quality Assurance
• GMP
• GLP
• GDP
• Regulatory compliance
• Batch record review
• SOP management
• CAPA
• Change control
• Environmental monitoring
• Quality Management System
• Molecular biology
• Biochemistry
• Data analysis
• Microsoft Excel
• Communication skills
• Training Records Management
• Vaccine Development
• Training Coordination
• Good Laboratory Practice (GLP)
• Document Control
• Quality Management Systems
• Data Analysis
• Chemistry
• Auditing
• Medical Science
• Biotechnology
• Molecular Biology
• Biology
• Good Manufacturing Practices
• Corrective And Preventive Action (CAPA)
• Change Control
• Version Control
• Computer Literacy
• Learning Management Systems
• Environmental Monitoring
• External Auditing
• Infectious Diseases
• Internal Auditing
• Problem Solving
• MRNAs
• Pharmaceuticals
• Microsoft PowerPoint
• Presentations
• Quality Management
• Safety Assurance
• Writing
• Coordinating
• Investigation

Domaines d’emploi

• Healthcare
• Science & Research
• Manufacturing
• Quality Assurance Associate
• Quality Assurance Specialist
• Product Graders and Testers (except Foods and Beverages)
• Inspectors, Testers, Sorters, Samplers, and Weighers