Quality Engineer: CAPA & Validation for GMP Manufacturing

NCSL International; Tempe (AZ); Hybrid; USD 75,000 - 110,000; Full time

Benefits offered by this job

Comprehensive benefits

Paid time off

401(k)

Job summary

AbbVie is seeking a Quality Engineer for its Tempe, AZ manufacturing facility to lead Manufacturing Quality Assurance activities, including deviation resolution, CAPA execution, and regulatory compliance. The role covers SOP governance, calibration oversight, and quality improvement initiatives across the plant.

You will collaborate with Validation and Plant teams to ensure cGMP adherence and alignment with Abbott policies, applying strong problem solving and communication skills daily.

Qualifications

• Bachelor's degree required in Biology, Chemistry, Engineering or related field.
• 2+ years of experience in Manufacturing, Quality, or Engineering.
• Strong verbal and written communication skills.
• Good problem solving and analytical skills.
• Good interpersonal and negotiation skills.
• Knowledge of quality/compliance management and regulatory standards for API/Bulk/Finished goods manufacturing.

Responsibilities

• Assist in validation and certification of new process equipment and review certified systems for QA readiness.
• Maintain and improve the Quality System and ensure adherence to policies and regulations.
• Support quality goals and ensure practices and procedures comply with company policies and applicable regulations.
• Ensure investigations of plant events are thorough, documented, and included in the CAPA system; perform product impact analyses and QA holds when needed.
• Maintain liaison with other Quality areas and Plant departments to ensure alignment.
• Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
• Approve SOPs and calibration requests with appropriate product/process limits.
• Develop and implement statistical quality programs and ensure acceptance sampling meets product quality confidence levels.

Skills

Verbal and written communication

Problem solving

Interpersonal relations

Negotiation skills

Quality/compliance management

Education

Bachelor's degree in Biology, Chemistry or Engineering

Job description

AbbVie is seeking a Quality Engineer for its Tempe, AZ manufacturing facility to lead Manufacturing Quality Assurance activities, including deviation resolution, CAPA execution, and regulatory compliance. The role covers SOP governance, calibration oversight, and quality improvement initiatives across the plant.

You will collaborate with Validation and Plant teams to ensure cGMP adherence and alignment with Abbott policies, applying strong problem solving and communication skills daily.