AbbVie

2021 Experiential Internship Quality Assurance Audit Associate

Posted on: 28 Jan 2021

Lake County, IL

Job Description

About AbbVie
AbbVies mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womens health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose:

* Assist in the management of Good Clinical Practice (GCP) activities in the support of studies and projects across one or more clinical programs.
* Assist and coordinate review and tracking of audit responses and associated tasks across therapeutic areas.
* Support the clinical development program by conducting GCP quality related activities such as risk-based analyses, system/process audits, and other types of assessments.
* Interact with Clinical Operations teams and supporting functions to ensure quality compliance.
* Escalates potential quality issues to management.

Responsibilities:

* Support review of audit responses for adequacy, consistency and compliance.
* Support businesses in understanding of audit response processes and use of technology
* Work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
* Demonstrate good judgment in selecting methods and techniques for obtaining solutions.
* Work independently as well as part of a team.
* Maintain effective communication of program related information.

Qualifications
Qualifications:

* Bachelor's Degree in a physical science, life science, nursing, pharmacy, or equivalent experience desired.
* Minimum of 4+ years of experience in Pharma industry; prefer Quality Assurance, R&D;, Project Management, Regulatory Affairs, Clinical Operations, or related field.
* Demonstrate proven track record utilizing core and technical competencies in managing projects; preferably in a clinical research function.
* Strong communication skills
* Excellent skills in use of Microsoft applications (Excel, PowerPoint, Word, Visio) and database applications, such as TrackWise.
* 3.0 minimum GPA
* Returning to university for at least one semester and graduating within one-year post internship
* Demonstrated leadership skills (i.e., extracurricular activities or projects)
* Authorized to work in the U.S. on a permanent basis without requiring sponsorship (students on an F1 visa with CPT may be accommodated if the department can sponsor in a full-time employee capacity)

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Internship
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.

AbbVie

Chicago, IL

AbbVie Inc. discovers, develops, manufactures, and sells pharmaceutical products in the United States, Japan, Germany, Canada, Italy, Spain, the Netherlands, the United Kingdom, Brazil, and internationally. The company offers HUMIRA, a therapy administered as an injection for autoimmune and intestinal Behçet's diseases; IMBRUVICA to treat adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma, waldenström’s macroglobulinemia, marginal zone lymphoma, and chronic graft versus host disease; VENCLEXTA, a BCL-2 inhibitor used to treat adults with CLL or SLL; VIEKIRA PAK, an interferon-free therapy to treat adults with genotype 1 chronic hepatitis C virus (HCV); TECHNIVIE to treat adults with genotype 4 HCV infection; and MAVYRET to treat patients with chronic HCV genotype 1-6 infection.

It also provides KALETRA, an anti-human immunodeficiency virus (HIV)-1 medicine used with other anti-HIV-1 medications to maintain viral suppression in HIV-1 patients; NORVIR, a protease inhibitor indicated in combination with other antiretroviral agents to treat HIV-1; and SYNAGIS to prevent respiratory syncytial virus infection at-risk infants. In addition, the company offers AndroGel, a testosterone replacement therapy for males; CREON, a pancreatic enzyme therapy for exocrine pancreatic insufficiency; Synthroid to treat hypothyroidism; and Lupron to treat prostate cancer, endometriosis, and central precocious puberty, as well as anemia.

Further, it provides Duopa and Duodopa, a levodopa-carbidopa intestinal gel to treat Parkinson’s disease; Sevoflurane, an anesthesia product; and ORILISSA, a non-peptide small molecule gonadotropin-releasing hormone antagonist for women with moderate to severe endometriosis pain. It has collaborations with Alector, Inc.; Janssen Biotech, Inc.; Galapagos; Bristol-Myers Squibb Company; and Calico Life Sciences LLC. The company was incorporated in 2012 and is headquartered in North Chicago, Illinois.

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