Engineer, Quality

Responsibilities

• Responsible for maintenance of the approved supplier list including material, service, and supplier qualification, performance, and discontinuation.
• Assists Materials Management, Procurement, and QA functions with material and supplier approval/rejections and supplier issue resolution of purchased materials.
• Assists site Manufacturing operations and Quality Assurance with supplier related event resolution, communication, and supplier-related corrective actions.
• Maintains an effective liaison and cooperative relationship with internal, global, and cross-functional departments
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Provides support to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations.
• Ensures investigations of site supplier events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for site supplier events and places material/product on QA hold where appropriate.
• Approves standard operating procedures; ensures procedures comply with policy and make sense.
• Participates in internal and external audits acting as the subject matter expert for site supplier quality assurance.
• Develop and implement statistical quality programs, ensure all acceptance sampling is capable of meeting expected product quality confidence levels for manufactured as well as purchased materials.
• 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.

Requirements

• Knowledge of quality systems (TrackWise, Veeva OneVault/OneTrack, SAP Enterprise) and processing software (excel, PowerPoint, word, SharePoint, etc.)
• Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
• 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.
• 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

Benefits

Additional Information

The Quality Engineer is responsible for carrying out Supplier Quality Assurance functions supporting AbbVie Lake County manufacturing sites including oversight of the Approved Supplier List, supplier qualification, supplier performance and maintenance, supplier audits, and supplier corrective action requests. This role collaborates with internal and global teams to support site QA responsibilities including investigations, impact analysis, corrective and preventive actions, quality system compliance, approval of standard operating procedures, quality improvement programs, and assurance of cGMP and AbbVie policy compliance for the manufacturing plants.

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