Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job DescriptionAbbVie is dedicated to improving healthcare by providing high quality, safe, effective products and ensuring compliance. This is achieved through a commitment to quality and the continuing effectiveness of the AbbVie Quality System to meet customer and regulatory requirements.The Supply Chain Quality (SCQA) Specialist ensures our services meet the established quality standards of the AbbVie Quality System, to assure the right products are delivered to the right customer, at the right time and under the right conditions. The SCQA Specialist proposes measures and improvements to enhance our Supply Chain Quality processes, systems and tools. The SCQA Specialist is a member of the Global Supply Chain Quality Assurance (SCQA) organization and provides support to various stakeholders within the Supply Chain network.The SCQA Specialist is responsible for providing quality assurance support for some or all of the following supply chain processes: pharmaceutical products, medical devices, combination products, biologics and cosmetics. Specific areas of support may include the Document Control, Product Quality Plans, Agency inspections/internal audits, Training and CAPA. This position will ensure that all product, process or system related quality activities within supply chain of the product are in compliance with Corporate and governmental regulations.Responsibilities:The SCQA Specialist responsibilities could include:
Coordinate and execute against our Change Control & Risk Assessments framework for Supply Chain Quality. Execute and/or monitor the timely completion of documented actions.
Coordinate and execute against our ER’s / Non-Conformities / Deviations / Complaints framework for Supply Chain Quality, including oversight and coordination across various SCQA functions. Execute and monitor the timely completion of action plans through our CAPA framework, to drive continuous improvements of our products, distribution network and our quality system. This includes oversight and coordination across various SCQA functions and relevant stakeholders.
Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
Assist project teams in planning, preparation, review and approval of quality documentation.
Complete and route change requests for process document creation, maintenance, and implementation.
Supports, Leads or co-lead audits of documentation, facilities and equipment.
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 system.
Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
Participate in training and education programs for various aspects of quality assurance.
For roles and responsibilities as described in this document:
Assures timely implementation of activities, to support business expansion and/or network optimizations associated to new product introductions and/or EU MDR Set Up.
Identify opportunities for Key Performance Indicators (KPI) and Process Indicator (PI) improvements and coordinate the implementation of these changes. Identify root cause trends across the KPI and PI framework and address opportunities for improvement and report to SCQA management.
Provides input to the Management Review process.
QualificationsQualifications:
Bachelor’s Degree in Supply Chain, Logistics, Medical, Scientific, Life Science, Engineering or equivalent fields preferred
3+ years’ experience in quality assurance, quality oversight or relevant experience.Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological or device related products preferred.Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting cosmetics, device, biologics, and pharmaceutical products preferred.Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
Previous TrackWise experience is a strong advantage
Strong oral and written communication skills needed.Excellent interpersonal skills a plus.Runs small projects to deliver tactical results.Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is a considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.