Compliance Specialist

AbbVie; Tempe (AZ); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Paid time off (vacation, holidays, sick)

Medical, dental, vision insurance

401(k) for eligible employees

Short-term incentive programs

Job summary

Allergan in Tempe, AZ is looking for a qualified individual to assist with internal audits that ensure compliance within production operations. You will be responsible for supporting various inspections and follow-up on audit action plans.

The ideal candidate has a Bachelor’s Degree in Science or Engineering and at least three years of biopharmaceutical experience. A comprehensive benefits package is provided to eligible employees, including medical and dental insurance, paid time off, and 401(k).

Qualifications

• 3+ years of biopharmaceutical experience.
• Quality Assurance, Regulatory Affairs, or Compliance experience preferred.
• Ability to evaluate compliance with GMPs and BOPs.

Responsibilities

• Assist with planning and conducting internal compliance audits.
• Support company and regulatory agency inspections.
• Follow up on audits to assure timely action plans.

Skills

Compliance auditing

Regulatory knowledge

Quality Assurance

Problem-solving

Education

Bachelor’s Degree in Science or Engineering

Job description

Job Description

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 (CAPAs).
• 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, or Compliance experience is preferred.
• Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA).
• 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.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical, dental, vision insurance and 401(k) for eligible employees.
• Eligibility to participate in short‑term incentive programs.

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.