Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) .

Job Description

Purpose

This position performs as Quality Assurance specialist in the area of quality systems to oversight operations, production, and laboratories to ensure all related activities are performed within regulatory and industries standards.

Responsibilities

• Assist with the management of Quality System oversight for operational activities, production, and laboratories, to ensure an independent assessment and address potential conflicts of interest between ownership and administration.

• Reviews processes to ensure they meet current regulatory expectations (i.e., cGMP and compliance) by providing guidance, and approving procedures and exceptions records.

• Review and approve site process LIR’s, Non-Conformances and CAPA’s.

• Analyze actions and metrics (process capability, control charts, measurement quality) to monitor system effectiveness and to enable managers to make sound product quality decisions.

• Perform root-cause analysis to identify and implement corrective actions and process improvements.

• Execute and help optimize the Quality Management System (QMS).

• Report to management on quality issues, trends and preventive actions.

• Interact with customers to build strong relationships, identify opportunities for improvement and establish feedback with manufacturing and development personnel.

• Serves as the QS liaison with all vested parties including QA/QC laboratories, IS, Manufacturing, and Engineering relating to process. Review and approve site procedures to ensure adherence to current GMP and industry standards.

• Perform other duties as assigned.

Qualifications

• Bachelor’s Degree in the Sciences, Engineering, Statistics, or a related field from an accredited institution. CQE Certification is preferred.

• 8+ years of combined experience (5 years minimum experience with a minimum of 3 years working in a relevant area such as Quality Assurance or Control, Validation, or Quality Laboratories.

• Strong proficiency in Excel and Statistical programs like Minitab.

• Experience in a GMP regulated environment preferred.

• Experience in an aseptic manufacturing environment preferred.

• Demonstrated ability to apply analytical methods and strong detail orientation.

• Strong technical written and oral communication skills.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​​

• This job is eligible to participate in our short-term incentive programs. ​​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Salary: $91,500 - $173,500