QA Audit and Compliance Auditor

2 weeks ago

North Chicago, United States AbbVie Full time

**Company Description**

The function of Audit and Compliance Auditor I is to perform evaluations for compliance with US and foreign regulation requirements (mínimally may include the Americas, Asia, Africa, Australia, European Middle East regions) and provide constructive evaluation of quality related systems for suppliers that provide materials, services and products to AbbVie. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers and third party manufacturers. Their execution in the area of GMP compliance and quality assures that activities are performed and documented in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality, effectiveness and safety of our products.

**Responsibilities**:

- Assess compliance of systems, facilities, and procedures per applicable regulations through audits and assessments of our suppliers, assuring compliance to regulatory requirements and AbbVie specifications.
- Provide feedback in the form of audit observations, formulate recommendations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained at the supplier.
- The position serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and objectivity.
- Participate in strategic initiatives to improve compliance to regulatory requirements and standards.

**Qualifications**
- Bachelor’s Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 4 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries.
- Must have a technical background and requires understanding of the audit process and knowledge of worldwide requirements related to GMP regulations for quality systems and compliance.
- Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management.
- The individual must have excellent oral/written communications skills.
- Personal skills needed include interpersonal skills, tact, open mindedness, maturity, tenacity, self-reliance, organizational/administrative skills and sound judgment. Effective communication skills are essential with an ability to work effectively outside of the company and across functional and technical areas.
- 2+ years in Quality Assurance with some project management experience in the pharmaceutical, medical device/nutritional or related industry. One year in compliance/auditing or regulatory affairs is desirable. Total combined experience expected to be at least 6 years.
- ASQ certification desired, not required.
For specific U.S. manufacturing sites, performs batch release.

**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 a 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.

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