Snr Quality Engineer, Combo Product External Quality
AbbVie
2 months ago
On-site
Tempe, AZ
Operations
Responsibilities:
- Implement and maintain the effectiveness of the Quality System.
- Ensure quality goals are met and practices comply with company policies and applicable regulations.
- Resolve deviations; conduct product impact analyses; execute corrective and preventive actions.
- Lead/participate in investigations; ensure plant event investigations are thorough, documented, and included in the plant CAPA system; place product on QA hold where appropriate.
- Maintain liaison with other Quality areas and Plant departments.
- Participate on the Validation Review Board (Manufacturing Quality Assurance function).
- Approve standard operating procedures (ensure they comply with policy).
- Oversee plant calibration program; approve calibration requests with appropriate product/process limits.
- Audit commissioning and validation documentation.
- Develop product quality plans and systems (specifications, risk analyses, FMEA’s); develop/implement statistical quality programs and process monitoring.
- Review/approve critical planned maintenance routines.
- For specific U.S. sites, perform batch release.
Qualifications:
- Bachelor’s degree (preferably Biology, Chemistry, or Engineering).
- 6+ years in Manufacturing, Quality, or Engineering.
- Strong verbal/written communication; problem solving/analytical skills.
- Strong interpersonal and negotiation skills.
- Knowledge of quality/compliance management and regulations/standards for API, Bulk Drug, or Finished goods manufacturing.
Benefits (if applicable): paid time off; medical/dental/vision insurance; 401(k); eligibility for short-term incentive programs.
- Implement and maintain the effectiveness of the Quality System.
- Ensure quality goals are met and practices comply with company policies and applicable regulations.
- Resolve deviations; conduct product impact analyses; execute corrective and preventive actions.
- Lead/participate in investigations; ensure plant event investigations are thorough, documented, and included in the plant CAPA system; place product on QA hold where appropriate.
- Maintain liaison with other Quality areas and Plant departments.
- Participate on the Validation Review Board (Manufacturing Quality Assurance function).
- Approve standard operating procedures (ensure they comply with policy).
- Oversee plant calibration program; approve calibration requests with appropriate product/process limits.
- Audit commissioning and validation documentation.
- Develop product quality plans and systems (specifications, risk analyses, FMEA’s); develop/implement statistical quality programs and process monitoring.
- Review/approve critical planned maintenance routines.
- For specific U.S. sites, perform batch release.
Qualifications:
- Bachelor’s degree (preferably Biology, Chemistry, or Engineering).
- 6+ years in Manufacturing, Quality, or Engineering.
- Strong verbal/written communication; problem solving/analytical skills.
- Strong interpersonal and negotiation skills.
- Knowledge of quality/compliance management and regulations/standards for API, Bulk Drug, or Finished goods manufacturing.
Benefits (if applicable): paid time off; medical/dental/vision insurance; 401(k); eligibility for short-term incentive programs.