Quality Engineer
AbbVie
2 months ago
On-site
Tempe, AZ
Operations
Quality Engineer — Manufacturing Quality Assurance (Plant)
Responsibilities:
- Assist Validation Engineer with validation and certification of new process equipment; periodically review certified systems to ensure quality requirements are met.
- Implement and maintain the effectiveness of the Quality System.
- Ensure quality goals are met and practices/procedures comply with company policies and applicable regulations.
- Ensure thorough, accurate investigations of plant events; document results and include them in the plant CAPA system; perform product impact analyses and place product on QA hold when appropriate.
- Maintain liaison/cooperative relationships with other Quality areas and Plant departments.
- Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
- Approve standard operating procedures (SOPs) and ensure compliance with policy.
- Approve calibration requests and ensure appropriate product/process limits are assigned.
- Develop and implement statistical quality programs; ensure acceptance sampling meets expected product quality confidence levels for manufactured and purchased materials.
Qualifications:
- Bachelor’s degree, preferably in Biology, Chemistry, or Engineering (or equivalent related experience).
- 2+ years of experience in Manufacturing, Quality, or Engineering.
- Good verbal and written communication skills.
- Strong problem-solving and analytical skills.
- Good interpersonal/communication skills.
- Negotiation skills.
- Knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug, or finished goods manufacturing.
Responsibilities:
- Assist Validation Engineer with validation and certification of new process equipment; periodically review certified systems to ensure quality requirements are met.
- Implement and maintain the effectiveness of the Quality System.
- Ensure quality goals are met and practices/procedures comply with company policies and applicable regulations.
- Ensure thorough, accurate investigations of plant events; document results and include them in the plant CAPA system; perform product impact analyses and place product on QA hold when appropriate.
- Maintain liaison/cooperative relationships with other Quality areas and Plant departments.
- Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
- Approve standard operating procedures (SOPs) and ensure compliance with policy.
- Approve calibration requests and ensure appropriate product/process limits are assigned.
- Develop and implement statistical quality programs; ensure acceptance sampling meets expected product quality confidence levels for manufactured and purchased materials.
Qualifications:
- Bachelor’s degree, preferably in Biology, Chemistry, or Engineering (or equivalent related experience).
- 2+ years of experience in Manufacturing, Quality, or Engineering.
- Good verbal and written communication skills.
- Strong problem-solving and analytical skills.
- Good interpersonal/communication skills.
- Negotiation skills.
- Knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug, or finished goods manufacturing.