Quality Engineer: CAPA, Validation & GMP Compliance

AbbVie; Tempe (AZ); On-site; USD 66,000 - 126,000; Full time

Job summary

AbbVie in Tempe, AZ is seeking a Quality Engineer to perform Manufacturing Quality Assurance activities, resolve deviations, perform product impact analyses, and drive corrective and preventive actions in compliance with cGMP.

You will lead investigations, approve SOPs, oversee calibration programs, support quality improvement initiatives, and interact with cross-functional teams to ensure product quality from input to finished goods.

Qualifications

• Bachelor's degree in biology, chemistry, or engineering, or equivalent related experience.
• 2+ years of experience in Manufacturing, Quality or Engineering.
• Strong verbal and written communication skills.
• Good problem solving and analytical skills.
• Strong interpersonal and communications skills.
• Knowledge of quality/compliance management for API, bulk drug, or finished goods manufacturing.

Responsibilities

• Assist Validation Engineer in the validation and certification of all new process equipment and periodically review all certified systems to assure the capability of meeting quality requirements.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Support to ensure that all quality goals are met, and all practices and procedures comply with company policies and applicable regulations.
• Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and places product on QA hold where appropriate.
• Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Participates on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approves standard operating procedures; ensures procedures comply with policy and make sense.
• Approves calibration requests and ensures that these requests have appropriate product/process limits assigned.
• Develop and implement statistical quality programs, assure all acceptance sampling is capable of meeting expected product quality confidence levels for manufactured as well as purchased materials.

Skills

Verbal and written communication

Problem solving

Analytical skills

Interpersonal skills

Education

Bachelor's degree in Biology, Chemistry or Engineering

Job description

AbbVie in Tempe, AZ is seeking a Quality Engineer to perform Manufacturing Quality Assurance activities, resolve deviations, perform product impact analyses, and drive corrective and preventive actions in compliance with cGMP.

You will lead investigations, approve SOPs, oversee calibration programs, support quality improvement initiatives, and interact with cross-functional teams to ensure product quality from input to finished goods.