Senior Quality Assurance Specialist – Consultant

🔥 1 minute ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Cencora

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

• Support Cencora’s patient and provider support and pharmaceutical commercialization services in Canada through Innomar Strategies • Support execution of quality-related tasks and activities for the Innomar QA Consultancy group • Maintain importer Drug Establishment Licenses and approve foreign sites for multiple clients • Coordinate with clients and foreign sites to receive, review, and update master documents for GMP compliance and product release • Release commercial drug products and clinical trial supplies to the Canadian market • Review manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, and other product release documents • Prepare quality performance indicators and client-specific report metrics, acting as Team Lead when required • Maintain and review SOPs, APQRs, stability reports, qualification and validation protocols and reports, artwork, and temperature studies • Process deviation investigations, product quality complaints, and change control requests, including reports and trend analysis • Assist with developing, revising, and implementing QA policies and procedures • Maintain copies of client and foreign-site documents and submissions to Health Canada for retrieval • Support internal, client, third-party, and regulatory audits and inspections • Support client and internal recalls and mock recalls, acting as Team Lead when required • Liaise with internal and external contacts, including potential clients • Participate in project teams and advise departments on Quality Assurance issues and strategies • Travel up to 20% may be required

🎯 Requirements

• Bachelor’s degree in a pharmaceutical or healthcare related field, such as chemistry, biology, microbiology, pharmacy, or pharmacology • Minimum of 5 years’ experience in Quality Assurance • Regulatory Affairs or Quality Assurance Certification is considered an asset • Experience in conducting vendor audits is considered an asset • Experience in hosting/co-hosting client audits is considered an asset • Experience working in an Operations environment is considered an asset • Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations, and associated guidelines • Demonstrated ability to prioritize, coordinate, and complete multiple projects within established timeframes • Demonstrated ability in deviation management, root cause analysis, and CAPA implementation • Ability to identify pragmatic solutions to compliance and operational problems • Strong attention to detail and data analysis skills • Ability to work independently and in a team environment • Proficiency with MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, eQMS, EMS, WMS, CRM, productivity tools, and Quality Management Systems • Excellent written and verbal communication skills • Knowledge of GCP, GMP, GDP regulations, and data integrity principles • Ability to work under general guidance and prioritize workload • Ability to identify straightforward problems and apply precedents to resolve them • ASQ Certified Quality Auditor, ISO 9001 Lead Auditor, or equivalent preferred

🏖️ Benefits

• Medical, dental, and vision care • Backup dependent care • Adoption assistance • Infertility coverage • Family building support • Behavioral health solutions • Paid parental leave • Paid caregiver leave • Training programs • Professional development resources • Mentorship programs • Employee resource groups • Volunteer activities

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