Senior Specialist, Quality Systems
Senior Specialist, Quality Systems
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1 Vacancy
Job Description
Job Description
About AbbVie AbbVies mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples lives across several key therapeutic areas: immunology oncology neuroscience eye care virology womens health and gastroenterology in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie please visit us at . Follow @abbvie on Twitter Facebook Instagram YouTube and LinkedIn.
The Sr Specialist Quality Systems within the Product Quality Assurance department is responsible for providing quality assurance support for the biologics manufacturing processes at AbbVie Bioresearch Center. Specific areas of support may include but not limited to New Product Introduction (NPI) Shop Floor Manufacturing Document Change Control Batch Release and CAPA. This position will ensure that all product process or system related quality activities from raw material inspection through shipment of final product disposition are in compliance with Corporate and governmental regulations.
Responsibilities
Serve as the Quality reviewer and approval for of change requests including but not limited to site policy/procedure standard operating procedures test methods and batch records.
Complete and route change requests for quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
Design effective quality systems procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
Provide shop floor QA support to ensure GMP compliance and product quality is maintained.
Work closely with cross functional teams to drive batch compilation and release activities to meet required cycle time.
Support CAPA investigations as necessary.
May be required to prepare and present data during regulatory audits (FDA EMA Anvisa etc) and internal audits.
Interact with internal and external partners for development of best practices in our quality systems and procedures.
Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
Contribute and prepare training and education programs for various aspects of quality assurance.
Qualifications :
Qualifications
Bachelors Degree in Chemistry Pharmacy Biology Microbiology Engineering or other technical/ scientific area preferred.
5 years experience in quality assurance quality oversight or relevant experience.
Technical knowledge in as many of the following areas as possible: Quality Regulatory Process Sciences Manufacturing Operations.
Knowledge and familiarity with product process equipment and facilities of pharmaceutical biological or device related products.
Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device biologics and pharmaceutical products.
Experience working in both team setting and independently. Works well with manager guidance while able to manage own time.
Strong oral (with all levels of management) and written communication skills needed. Excellent interpersonal skills a plus.
Runs and manages small to medium sized quality related projects
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 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 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 :
Full-time
Employment Type
Full-time
