[Hiring] Senior Quality Assurance Specialist @Cencora

Role Description

This role is in support of Cencora’s patient and provider support and pharma commercialization services in Canada marketed through our Innomar Strategies business. The Senior QA Specialist (Consulting) reports into the Manager, Quality Assurance and will support the execution of all quality related tasks and activities undertaken by the Innomar QA Consultancy group. The Quality Assurance Specialist (Consulting) will assist with the maintenance of Establishment Licenses (DELs, MDELs, SLs etc.), the release of commercial drug products, medical devices, natural health products, and clinical trial supply to the Canadian market, the preparation and review of quality/compliance related documentation, and the execution of other quality related tasks and activities as assigned by QA Management.

Responsibilities

• Maintenance of importer Drug Establishment Licenses (DELs) and the approval process for a large number of foreign sites for multiple clients.
• Coordinate with clients and/or foreign sites for the receipt, review and updates to master documents to ensure compliance to GMPs and in relation to product release activities.
• Release of commercial drug product and/or clinical trial supply to the Canadian market for Innomar or customers as required.
• Perform timely review and assessment of documents received from clients/foreign sites, including but not limited to manufacturing and packaging records, Certificates of Analysis, Certificates of Manufacture, and other product release documents.
• Assist Management in the preparation of routine key quality performance indicators (KPIs) to generate client specific report metrics, acting as a Team Lead when required.
• Maintain and review in-house and client-based quality documents, e.g. SOPs, APQR, stability reports, qualification/validation protocols and reports, artwork, temperature studies etc.
• Process Deviation investigations, including report generation and any associated trend analysis.
• Process Product Quality Complaints (PQCs), including report generation and any associated trend analysis.
• Process Change Control Requests (CCRs), including report generation and any associated trend analysis.
• Assist QA Management in the development/revision and implementation of QA policies and procedures, acting as a Team Lead when required.
• Sustain an effective system for maintaining copies of documents received from clients/foreign sites as well as those submitted to Health Canada, allowing ease of location and retrieval of records.
• Provide support during audits/inspections (i.e. internal, client, third party or regulatory agencies) as required.
• Provide support during recall/mock recall events (client and internal) as required, acting as a Team Lead when required.
• Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients.
• Participate in and support project teams and advise other departments on Quality Assurance issues and strategies, when required.
• Travel up to 20% may be required.

Qualifications

• Bachelor’s degree in a pharmaceutical or healthcare related field (e.g. chemistry, biology, microbiology, pharmacy, and pharmacology).

Requirements

• 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.

Skills & Knowledge

• Comprehensive knowledge of the Food and Drugs Act, Health Canada GMP regulations and associated guidelines.
• Demonstrated ability to effectively prioritize, coordinate and complete multiple projects within established timeframes.
• Demonstrated ability in the effective management of deviations, root cause analysis, and CAPA implementation.
• The ability to identify pragmatic solutions to compliance/operational problems and challenges.
• Strong attention to detail, proven data analysis skills and the ability to present these findings effectively.
• Ability to work both independently and in a team environment, always promoting positive, respectful and professional relationships.
• Strong proficiency in common office applications (e.g. MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, etc.) and the ability to achieve rapid fluency in business related electronic applications/platforms (e.g., eQMS, EMS, WMS, CRM, etc.).
• Excellent written and verbal communication skills.
• Knowledge of GCP, GMP, and GDP regulations and data integrity principles.
• Ability to work under general guidance and prioritize personal workload effectively.
• Ability to identify straightforward problems and apply precedents to resolve them.
• Proficiency with standard productivity tools and Quality Management Systems (QMS).

Certifications

• Certified in ASQ Certified Quality Auditor (CQA), ISO 9001 Lead Auditor (QMS) or equivalent preferred.

Benefits

• Compensation, benefits, and resources that enable a highly inclusive culture.
• Traditional offerings like medical, dental, and vision care.
• Comprehensive suite of benefits focusing on physical, emotional, financial, and social aspects of wellness.
• Support for working families, including backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.
• Variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and more.