About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Joining AbbVie means, you will be part of a team of outstanding professionals dedicated to making a remarkable impact on patients' lives. At AbbVie, we conduct ground-breaking science on a global scale every day. AbbVie Canada is one of the Best Workplaces in Canada whereby 92% of our employees are proud to say they work for AbbVie. When choosing your career path, choose to be remarkable. AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health, in addition to products and services across its Allergan Aesthetics portfolio. Under the direction of the Senior QA Manager (SrQAM) , the Quality Assurance Associate (QAA) is responsible for providing quality assurance support for quality system requirements associated with: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include Storage and Distribution, Distribution product complaints, potential quality events/product shortage execution, Supplier Controls, Product Quality Review, Risk Management, Agency inspections/internal audits, CAPA, and overall Quality Manual requirements. This position will ensure that all product, process or system related quality activities supporting the business from receipt through shipment of final product are in compliance with Corporate, Health Canada’s Good Manufacturing Practices (GMP) and Medical Device Regulations. Key Responsibilities: Assist with the integration and support of quality regulations: drug, biologics, device and/or combination products. Assist in the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems. Partner, coordinate (as delegated) and support activities related to product actions at the affiliate. Assist the team in planning, preparation, review and approval of quality documentation pertaining (but not limited) to: Annual Product reviews, stability, New Product introduction, etc. Support the Affiliate QA Management in the preparation of the Affiliate Management Review . Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans. Participate in training and education programs for various aspects of quality assurance. Coordinate and investigate quality events such as deviations, non-conformances, distribution product complaints and corresponding action plans Quality management of supplier qualification program including implementation of Quality Technical agreements and performance monitoring for key suppliers. Ensure that established metrics and KPIs are being met. Execute and support the QA team and the third-party distribution warehouse with all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments and product returns. Represent affiliate QA in cross functional teams, projects and programs, as assigned by management. Qualifications Education/Experience Required: Holds a science degree (e.g., Biochemistry, Biology, Microbiology, Chemistry, etc.) or equivalent. 3 or more years’ experience in Quality Assurance in the Pharmaceutical Industry, quality oversight or relevant experience Experience in Pharmaceutical commercial distribution environment is preferred. Technical knowledge in as many of the following areas as possible: Quality, Regulatory, Process Science, Manufacturing Operations Essential Skills & Abilities: Good knowledge and understanding of Good Manufacturing Practices (GMP) Good Documentation Practices (GDP) and other GxPs-related guidelines as well as the Canadian Food and Drug Regulations. Team Player and Integrity Organizational and project management skills; Time Management skills; Ability to work within a team Strong communication Skills (Verbal and Written) with Internal and external Customers motivational, interpersonal and relationship building skills Excellent written and oral communication skills in French and English. decision-making skills; negotiation skills, effective collaboration. Strong computer skills (MS Office) knowledge of enterprise systems such as SAP, ComplianceWire, SolTraqs, Attaché and Attaché Pro is considered an asset. Other: Travel within Canada – 10% AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities and members of visible minorities to apply. Covid vaccination new hires amendments: Full vaccination against COVID-19 is a condition of employment for this position, with possible accommodation for validated exemptions, within the limits of applicable legislation. AbbVie employees are also required to comply with any COVID-19 related external requirements, including any testing requirements, applicable to their work activities outside AbbVie premises (for example, travelling and visiting stakeholders and customers). Travel Yes, 10 % of the Time Job Type Temporary Work Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.