Purpose:

The primary responsibility for the Quality Validation Review Specialist is the planning and overall approval of validation tasks. Under the direction of the Validation Section Manager, will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ key projects simultaneously. May be expected to coach/supervise contractors and/or junior Validation Specialists.

Responsibilities

• Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements.
• Ensure that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
• Execute tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended.
• Ensure investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy.
• Participate with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation.
• May Supervise contract validation resources, when applicable, to ensure timely completion of activities in his/her area of responsibility.
• Lead, author, and review investigations and implementation of preventive and corrective actions.

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Qualifications

• Bachelor's Degree required, preferably in Biology, Chemistry or Engineering related field.
• 6+ years of experience in Quality, Manufacturing or Engineering, including 4 major validation subjects (e.g., Facilities/Utilities/Equipment, Cleaning, Process, Computer, etc.), preferably in Biologics and Pharmaceutical industry.
• Ability to supervise junior or contract team members; previous supervisory or team lead experience preferred.
• Experience managing multiple complex projects (5+) simultaneously.
• Knowledge of quality and compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred.
• Excellent organizational and presentation skills; Excellent interpersonal and communication skills.
• Strong creative problem solving and analytical skills with the ability to negotiate and influence without authority.

You will receive:

• Comprehensive Healthcare: Medical, Vision, Dental, FSA, HSA
• Financial Well-being, Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• AbbVie Vitality: Health & Wellness programs including Employee Assistance Program (EAP), Health Advocate, Global Well-Being Programs
• Generous Paid Time Off include, Company Holidays, Vacation, Parental and Caregiver Leave
• Community Outreach Programs and company match of charitable contributions
• Perks include AbbVie Product Shop, Employee Loyalty Program, Tuition Assistance, Adoption and Surrogacy Assistance, Mothers at Work and Milk Stork to list a few

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.