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La misión de AbbVie es descubrir y distribuir medicamentos innovadores que resuelvan los serios problemas de salud de hoy y también abordar los desafíos médicos del mañana. Nos esforzamos por tener una repercusión excepcional en la vida de las personas con varias áreas terapéuticas claves: inmunología, oncología, neurociencia, cuidado de la vista, virología, y salud y gastroenterología de la mujer. Además, ofrecemos productos y servicios de la gama de Allergan Aesthetics. Para obtener más información sobre AbbVie, visítenos en www.abbvie.com. Siga a @abbvie en Twitter, Facebook, Instagram, YouTube y LinkedIn.

Engineer, Quality

Principal Branchburg Township, Nueva Jersey ID de la oferta 2200045 Categoría Quality Assurance División AbbVie

The Quality Engineer II will be responsible for the execution and tracking of daily production support activities regarding all aspects of product quality as well as provide support on site projects.

Major activities include, but are not limited to:

  • Perform risk assessments for nonconformances, CAPAs, ECOs. Etc.
  • Act as in internal consultant to various departments and teams for current interpretation of GMP/ISO/QMS.
  • Review equipment validations to support ad-hoc limited qualifications, new equipment qualifications, equipment and facility requiring re-qualifications, calibrations, etc. Ensure appropriate qualifications activities are performed and documented in compliance with GMPs, GTPs, and GDPs.  Review and approve validation documents in BRAM system, including remote off-shift review as required.
  • Review and approve documents under Change Control ensuring compliance with GMP, GDP, GTP, and regulatory standards such as ISO13485, 21CFR820, ISO14971, etc.
  • Support the Risk Management process throughout all quality system elements such as Design Control, Product Surveillance, Field Action, etc.  Update risk management file documents as needed.
  • Provide Quality support on project work and lead projects related to core production while ensuring compliance with applicable regulations/standards. Challenge the approach and provide innovative alternative solutions to protocol designs.
  • Provide guidance and direction on NCR and CAPA investigations.  Complete NCRs, CAPAs, and ECOs as required
  • Recommend enhancements / continuous improvements to the Quality Management System and QMS procedures.

 

KEY DUTIES AND RESPONSIBILITIES: Describe scope:

% of Time or

Importance

  • Review and approve validation documents in BRAM system, including remote off-shift review as required.

15%

  • Complete CAPAs/NCR’s/ECO’s as required

15 %

  • Review and approve documents under Change Control ensuring compliance with GMP, GDP, GTP, and regulatory standards such as ISO13485, 21CFR820, ISO14971, etc

10 %

  • Support the Risk Management process throughout all quality system elements such as Design Control, Product Surveillance, Complaints, NCRs, Field Action, etc.  Update risk management file documents as needed.

10 %

  • Provide Quality support on project work and lead projects related to core production while ensuring compliance with Design Controls and applicable regulations/standards. Challenge the approach and provide innovative alternative solutions to protocol designs

15%

  • Perform product impact / risk assessments for nonconformances, CAPAs, ECOs. Etc.

30 %

  • Recommend enhancements / continuous improvement of the QMS

5%


Education and Experience

  • Bachelor’s degree required in Engineering or Science
  • Minimum 3 years of Quality Assurance/Quality Engineering/Engineering/Operations experience
  • Validation lifecycle experience helpful but not required
  • Risk Management experience preferred
  • CAPA lifecycle experience, including root cause investigation
  • 21CFR820 and 1271
  • Technical writing
  • Basic statistics
  • Presentation and communication skills
  • GMP, GDP, GTP understanding
  • Change Control experience
  • Audit support experience helpful, but not required

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.


Responsabilidades Principales: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Viaje: No
Tipo de trabajo: Experienced
Horario: Full-time
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  • Quality Assurance, Branchburg Township, Nueva Jersey, Estados UnidosBorrar

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