Quality System Lead -CAPA & Training
Quality System Lead -CAPA & Training
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Salary Not Disclosed
1 Vacancy
Job Description
Purpose:
The Quality Systems Lead for CAPA & Training provides leadership and direction to the manufacturing site. This role is responsible for the effective implementation of the Quality systems and is expected to be lead improvement initiatives maintain the site in state of compliance and lead the site to meet the quality metrics for CAPA and training.
Responsibilities:
Leads and influences peers and colleagues to ensure CAPA and training metrics are met.
Responsible for various aspects of quality assurance related to products produced at the plant.
Responsible for the effective organization administration and training within the QA organization
Independently troubleshoot and resolve quality compliance issues.
Provides regulatory and technical guidance to departments.
Communicates with Management for Quality Management Review Quality Initiatives etc.
Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs.
Responsible for the Quality Onboarding and Training including implementation of improvement programs.
Qualifications :
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
.Key Stakeholders
Development Manufacturing Quality and Regulatory
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 and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
