Compliance Specialist

Compliance Officer Jobs; Tempe (AZ); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) plan

Paid time off

Job summary

AbbVie in Tempe, Arizona, is seeking a Compliance Specialist to assist with internal audit processes and regulatory inspections. The role supports CAPA tracking, management review metrics and supplier qualification activities to ensure GMP compliance across manufacturing operations.

Candidates should have a Bachelor’s degree in science or engineering and 3+ years in biopharma, with knowledge of CFR, MCA, DEA and GMP practices. This position is full-time with comprehensive benefits.

Qualifications

• Bachelor’s Degree in Science or Engineering required.
• 3+ years of Biopharmaceutical experience.
• Quality Assurance/Regulatory Affairs/Compliance preferred.
• Knowledge of Pharmaceuticals regulations (e.g., CFR, MCA, DEA).
• Familiarity with plant and company level procedures.
• Ability to evaluate quality and compliance across operations.

Responsibilities

• Assist planning and conduct internal compliance audits of facility operations.
• Support inspections by regulatory agencies (e.g., DEA, FDA).
• Follow up on audits to ensure corrective actions are completed timely.
• Assist with management reviews and related metrics for the plant.
• Support data collection/analysis for CAPA activities.
• Oversee supplier qualifications and re-qualifications.

Skills

Internal audits

Compliance

Regulatory knowledge

Problem solving

Education

Bachelor’s degree in Science or Engineering

Job description

Compliance Officer Jobs

Compliance Specialist

AbbVie Tempe, Arizona, United States Full-time 7 days ago

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.

Responsible for assisting with the internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards.

Responsibilities

• Assists with planning and conducting internal compliance audits of all operations within the facility.
• Provides support with company and regulatory agency (i.e. DEA, FDA) inspections.
• Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• Assist with management review and associated metrics for the plant
• Provides support in the metrics collection and analysis for compliance-related corrective and preventive actions (CAPA’s).
• Responsible for supplier qualifications including new suppliers, changes and re-qualifications.

Qualifications

• Bachelor’s Degree, preferably in Science or Engineering, or equivalent related work experience is required.
• 3+ years of Biopharmaceutical experience
• Quality Assurance/Regulatory Affairs/Compliance is preferred
• Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA).
• Must have some knowledge of plant and company level procedures.
• Ability to evaluate quality, production and support areas for compliance to GMPs. BOPs, etc.
• Ability to identify and investigate problems and help to resolve them.

Additional Information

• 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.
• 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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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