AbbVie

Data Integrity Engineer - Quality Operations

Employer
AbbVie
Location
Waco, TX, United States
Posted
Nov 13, 2020
Ref
203171
Required Education
Masters Degree/MBA
Position Type
Full time
This position performs as QA and has the responsibility to drive compliance improvements identified in the Waco site's Action Plan, relating to electronic systems compliance across the manufacturing network.

In this position, you will be responsible for the following:
  • Serving as SME for electronic system compliance in support of inspection readiness activities.
  • Overseeing investigation and corrective actions for non-conformances related to supplier quality, manufacturing and packaging, and support quality investigations outside of these areas as needed.
  • Working closely with Waco management peers and colleagues to ensure that quality representation is activity engaged in facility and capital project initiation and execution.
  • Providing electronic system compliance expertise to the revision of the DH/DI standard and to provide recommendations regarding DH/DI training materials.
  • Ensuring commissioning and validation activities are in-compliance with industry and site procedures.
  • Leading and participating in continuous improvement initiatives as appropriate.
  • Managing the change control processes for the site.
  • Providing QA support of FDA or other regulatory inspections.
  • Ensuring community of practice for DH/DI governance for electronic and hard copy data systems.
  • Supporting corporate initiatives as necessary.


Qualifications

Knowledge, Skills & Abilities
  • Ability to communicate accurately and timely.
  • Strong technical written and oral communication skills.
  • Excellent Interpersonal Skills.
  • Project Management skills.
  • Knowledge of Regulatory Compliance criteria established by Governmental Agencies, Boards of Health and Legislative Requirements.
  • Basic knowledge of strategic and tactical issues in an operations environment.
  • Demonstrated project management skills and the ability to influence others effectively.
  • The individual must be result orientated and able to demonstrate the use process measurement tools to achieve metrics.
  • Demonstrated process thinking skills and familiarity with knowledge management.
  • Demonstrated ability to apply analytical methods.
  • Demonstrated ability to work with all levels of Management.
  • Demonstrated business acumen.
  • Detail-oriented and self-motivated.

Experience
  • Minimum of eight (8) years of experience with a minimum of five (5) years working in relevant areas such as process validations or technology transfer.
  • Experience in a GMP regulated environment preferred.
  • Master's Degree may substitude for one year of experience.

Education
  • Minimum B.S. Engineering, analytical, or sciences degree from an accredited institution; Graduate degree is preferred.


Job Type
Standard

Schedule
Full-time

Equal Employment Opportunity
At Allergan, 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.