Specialist, Quality Systems

Responsibilities:

• Assist with proper integration and support of quality regulations: drug, biologics, device and/or combination products.
• Conduct integral regulatory review of documents
• Assist with audits of documentation, facilities and equipment
• Complete and route change requests for process document creation, maintenance and implementation. 
• Support project teams in planning, preparation, review and approval of quality documentation.
• Collect and compile key quality metric data.
• Perform QA review for product release
• Participate in training and education programs for various aspects of quality assurance.

Qualifications:

• Bachelor's Degree (Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/ scientific area preferred) or equivalent experience.
• 0-2 years' experience in quality assurance, quality oversight or relevant experience
• Knowledge and familiarity with product, process, equipment, and facilities of pharmaceutical, biological and medical device products preferred.
• Strong oral and written communication skills needed.
• Excellent interpersonal skills is a plus

AbbVie is an equal opportunity employer including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.