AbbVie

SVP Quality Analyst

Employer
AbbVie
Location
Barceloneta, PR, United States
Posted
Oct 28, 2020
Ref
2006399
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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 .

Support manufacturing operations in the resolution of events and documentation discrepancies. Provide guidance for product/process impact analysis, investigations, and risk-based evaluations in support to plant events. Responsible for implementing and maintaining the effectiveness of the Quality System.

  • Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with AbbVie policies and applicable regulations for the Quality areas under his /her responsibility.
  • Ensures investigations of plant events are evaluated in a timely manner; completed thoroughly and documented accurately in the plant CAPA system.
  • Performs product impact analyses for plant events and places product on QA hold where appropriate.
  • Participates in the Validation Review Board as the Manufacturing Quality Assurance function.
  • Approves standard operating procedures; change management and risk management documents. Ensures all documents are in compliance with Abbvie's global procedures and regulatory requirements.
  • Approves calibration requests, calibration out of tolerance, and preventive maintenance records. Ensures that these documents have appropriate justifications according to product /process limits established.
  • Demonstrates accountability and responsibility for EHS performance and compliance.
  • Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
  • Oversees manufacturing operations to ensure practices are in alignment with approved procedures.
  • Provide support to the Compliance team during internal and external audits as required.


Qualifications

  • Bachelor's degree in Biotechnology, Biology, Chemistry, or Engineering. Master's degree: not required but desired.
  • Quality/compliance management skills. This position requires knowledge of quality/compliance/Risk management as well as regulations and standards affecting biological products.
  • Experience in the Health care industry - 2 years. Experience in the Pharmaceutical industry - 2 years. Total combined minimum years of experience required - 2 years. (Not necessarily the sum of the above )
  • Fast-paced and continuously changing environment. Subject to work with multiple interruptions and under reasonable pressure due to the nature and function of the area.
  • Conform to EH&S management system requirements, promote continuous improvement, and consider EH&S aspects during the design and change process.
  • Candidates must be available for any shift.


Significant Work Activities
Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
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.