Quality Engineer IV
Quality Engineer IV
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Job Description
Purpose
The Quality Engineer IV performs as QA specialist in the area of quality assurance oversight of operations production process and equipment systems and computer validation as well site specific projects related to process improvement and optimization.
Responsibilities
- Provide Quality Assurance oversight and assessment of operational activities in Production Compliance Validations and Technical Services projects.
- Serve as the QA representative on Validation and Technical Services projects. Liaison to process and equipment validations for QA/QC laboratories BT Manufacturing and Engineering.
- Ensure process and equipment validations meet current regulatory expectations (cGMP compliance) by providing guidance and executing both internal and external audits of our processes.
- Review and approve equipment validation documentation (e.g. protocols deviations and final reports).
- Support change control activities associated with processes and equipment validations.
- Manage and coordinate QA support for new and existing process equipment validations implementation.
- Provide CSV oversight based on the education and training of the individual.
- Provide support in defining statistical design and analysis for process development technology transfer analytical development process validation and requalifications manufacturing chemistry and microbiology laboratories incoming QA investigations CAPAs compliance complaints process.
- Support investigations related to process and testing findings.
- Communicate effectively and promptly at all levels of the organization.
- Generate appropriate purchasing (CEs) and documentation for Quality Assurance validations projects and URS and FRS requirements.
- Responsible for implementing and maintaining the effectiveness of the Quality System.
- Help ensure all quality goals are met and all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility.
- Maintain an effective liaison and cooperative relationship with other Quality areas and Plant departments.
- Participate in Cross Functional Team meeting as Quality Engineering function to provide oversight and support site projects.
- Perform other duties as assigned.
Qualifications :
- Bachelors Degree required; preferably in Physical or Life Sciences Pharmacy or Engineering.
- 8 years of combined experience in Manufacturing QA R&D in pharmaceutical biologics device or chemical industry.
- Must be familiar with use of electronic document management and laboratory information management.
- Must also be familiar with AbbVie Quality Systems as well as cGMP and other regulatory requirements.
- Strong communication Skills both oral and written.
Additional Information :
Applicable 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 shortterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies 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.
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No
Employment Type :
Fulltime
Employment Type
Full-time
