Engineer, Quality

About the role

The Quality Engineer supports AbbVie Lake County manufacturing sites by overseeing supplier quality assurance functions, collaborating with internal and global teams, and ensuring compliance with cGMP and AbbVie policies.

Responsibilities

• Maintain the approved supplier list including material, service, and supplier qualification, performance, and discontinuation.
• Assist Materials Management, Procurement, and QA functions with material and supplier approval/rejections and supplier issue resolution of purchased materials.
• Assist site Manufacturing operations and Quality Assurance with supplier related event resolution, communication, and supplier-related corrective actions.
• Maintain an effective liaison and cooperative relationship with internal, global, and cross-functional departments.
• Implement and maintain the effectiveness of the Quality System.
• Support the achievement of quality goals, ensure practices and procedures comply with company policies and applicable regulations.
• Ensure thorough investigation of site supplier events, document accurately, and include in the plant CAPA system.
• Perform product impact analyses for site supplier events and place material/product on QA hold where appropriate.
• Approve standard operating procedures; ensure procedures comply with policy and make sense.
• Participate in internal and external audits as the subject matter expert for site supplier quality assurance.
• Develop and implement statistical quality programs, ensure all acceptance sampling meets expected product quality confidence levels.

Qualifications

• Bachelor's degree, preferably in Biology, Chemistry or Engineering or equivalent related experience.
• 2+ years of overall experience in Manufacturing, Quality or Engineering.
• Good verbal and written communication skills.
• Good problem solving and analytical skills.
• Good interpersonal relations / communications skills.
• Good negotiation skills.
• Knowledge of quality / compliance management as well as regulations and standards affecting Incoming Materials, API, Bulk Drug or Finished goods manufacturing.

Preferred Qualifications

• Knowledge of quality systems (TrackWise, Veeva OneVault/OneTrack, SAP Enterprise).
• Processing software (excel, PowerPoint, word, SharePoint, etc.).

Additional Information

Applicable 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 roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors 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 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 an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html. US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html.