Data Integrity Engineer - Quality Operations

AbbVie

  • Waco, TX
  • Permanent
  • Full-time
  • 21 days ago
  • Apply easily
Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , and .Job DescriptionOverview
This position performs as QA partner with Business Technology 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.Responsibilities
  • Maintain a program to comply with the requirements of the FDA, EU and ISO 13485:2003, and other relevant regulatory bodies for the site.
  • Provide direct oversight to local manufacturing and laboratory system across multiple sites related to Change Control and System functionality.
  • Establish and manage system control oversight.
  • Serve as SME for electronic system compliance in support of inspection readiness activities.
  • Oversee investigation and corrective actions for non-conformances related to supplier quality, manufacturing and packaging, and support quality investigations outside of these areas as needed.
  • Work closely with site management, peers and colleagues to ensure that quality representation is activity engaged in facility and capital project initiation and execution.
  • Provide electronic system compliance expertise to the revision of the DH/DI standard and to provide recommendations regarding DH/DI training materials.
  • Ensure commissioning and validation activities are in-compliance with industry and site procedures.
  • Lead and participate in continuous improvement initiatives as appropriate. Managing the change control processes for the site.
  • Provide QA support of FDA or other regulatory inspections.
  • Ensure community of practice for DH/DI governance for electronic and hard copy data systems.
  • Support corporate initiatives as necessary.
Qualifications
  • Bachelor’s Degree required; preferably in Engineering, Computer Science, or
Information Technology, or sciences degree from an accredited institution; Graduate degree is preferred. * 8+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry.
  • Minimum of Seven (7) years of experience with a minimum of Four (4) years working in relevant areas such as process validations or technology transfer or laboratory data control.
  • Experience in a GMP regulated environment preferred; Must be familiar with Quality systems, as well as cGMP and other regulatory environments.
  • Must be familiar with use of electronic document management and laboratory information management.
  • Strong communication Skills, both oral and written.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​​The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​This job is eligible to participate in our short-term incentive programs. ​​Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​​​AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. 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 protected veteran, or any other legally protected group status.

AbbVie