Sr. Quality Engineer, Combo Product External Quality
AbbVie
2 months ago
On-site
Tempe, AZ
Operations
The Senior Quality Engineer is responsible for carrying out Manufacturing Quality Assurance functions within the plant including resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, oversight of the plant calibration program, quality improvement programs, and assurance of cGMP and Abbott policy compliance for the manufacturing plant.
Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.
Responsibilities:
- Implement and maintain the effectiveness of the Quality System.
- Ensure quality goals are met and practices/procedures comply with company policies and applicable regulations for assigned quality areas.
- Ensure plant event investigations are thorough, accurately documented, and included in the plant CAPA system; perform product impact analyses and place product on QA hold where appropriate.
- Maintain liaison with other Quality areas and Plant departments.
- Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
- Approve standard operating procedures; ensure procedures comply with policy.
- Approve calibration requests and ensure appropriate product/process limits are assigned.
- Audit commissioning and validation documentation.
- Develop product quality plans and systems (product/quality specifications, quality plans, risk analyses, FMEA’s), and implement statistical quality programs/process monitoring.
- For specific U.S. manufacturing sites, perform batch release.
Qualifications:
- Bachelor’s degree, preferably in Biology, Chemistry or Engineering
- 6+ years of overall experience in Manufacturing, Quality or Engineering
- Good verbal and written communication skills
- Good problem-solving and analytical skills
- Good interpersonal/communication skills
- Good negotiation skills
- Knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug or Finished goods manufacturing
Supports the Quality Engineering group by auditing of commissioning and validation documentation completed by others, authoring and execution of newly identified qualification/validation protocols, review and approval of critical planned maintenance routines, and other quality assurance tasks assigned by the MQA Section Manager and/or the Plant QA Manager.
Responsibilities:
- Implement and maintain the effectiveness of the Quality System.
- Ensure quality goals are met and practices/procedures comply with company policies and applicable regulations for assigned quality areas.
- Ensure plant event investigations are thorough, accurately documented, and included in the plant CAPA system; perform product impact analyses and place product on QA hold where appropriate.
- Maintain liaison with other Quality areas and Plant departments.
- Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
- Approve standard operating procedures; ensure procedures comply with policy.
- Approve calibration requests and ensure appropriate product/process limits are assigned.
- Audit commissioning and validation documentation.
- Develop product quality plans and systems (product/quality specifications, quality plans, risk analyses, FMEA’s), and implement statistical quality programs/process monitoring.
- For specific U.S. manufacturing sites, perform batch release.
Qualifications:
- Bachelor’s degree, preferably in Biology, Chemistry or Engineering
- 6+ years of overall experience in Manufacturing, Quality or Engineering
- Good verbal and written communication skills
- Good problem-solving and analytical skills
- Good interpersonal/communication skills
- Good negotiation skills
- Knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug or Finished goods manufacturing