Quality Compliance Analyst II - Pharmaceutical

About AbbVie
AbbVie's 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 people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's 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 .

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. All while wearing jeans to work!

Quality Compliance Analyst II - Cincinnati, OH

WHAT YOUR NEW MANAGER WANTS YOU TO KNOW:

" I'm looking for a team player with experience in a fast-paced Manufacturing Environment. Our Quality Compliance Analyst II will play an important role on our team. If you want to jump start your path to a successful career and contribute to keeping patients safe, healthy, and happy, I would be very interested in receiving your resume. Let's discuss this exciting opportunity and your goals for the future. Be Bold!"

*YOU ARE more than just a title, YOU ARE...

A Trusted Advisor - The Quality Compliance Analyst II executes all tasks relating to compliance of the Quality Management System (QMS). He/she assists the Manager QA QMS with administrative duties in organizing and prioritizing QA compliance priorities to meet regulatory timelines. The Quality Assurance Compliance Analyst II leads improvement projects and sustainability related to compliance.

YOU WILL:

Excel as a quality expert.

• Execute the management of supplier qualification and all supplier documents such as Quality agreements, supplier scorecard, supplier audits and risk assessments. (35%)
• Compile and analyze data for Quality metrics for the site to support weekly and monthly reporting, local Quality Management review meetings, and Quarterly Corporate review meetings (20%)
• Author Annual Product and Product Risk Process (PRP) Reviews. Collect, tabulate and analyze data for the reviews and author the reports based on the data evaluation. Ensure timely completion of the reviews. (10%)
• Executes compliance to lifecycle maintenance for data integrity, quality risk management, and containment (10%)
• Execute internal audits in adherence with the annual internal audit schedule. (10%)
• Support the front and/or back room during site audits and inspections (5%)
• Author compliance related documents such as Site Master Plan and Quality Manual (5%)
• Execute the management of customs reconciliation process and compliance to regulations (5%)

Qualifications

YOU BRING:

• Bachelor's Degree in a related field is preferred (Scientific discipline is preferred).
• Five (5) years of experience related to pharma industry in a technical quality environment.
• Knowledge of the req uirements for compliance with environmental health and safety, cGMP procedures, and regulatory guidelines.

ABBVIE LEADERSHIP SKILLS:

For this role, we're looking for a production leader who is:

• Attention to Detail Focused
• Quality Focused
• Acts as an Owner

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
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.