Quality Systems Senior Specialist
Quality Systems Senior Specialist
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Job Description
The Quality Systems Senior Specialist is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products medical devices combination products and biologics. Specific areas of support may include the Document Center Device QA Labeling Validation Training and CAPA. This position will ensure that all product process or system related quality activities from raw material inspection through shipment of final product are in compliance with Corporate and governmental regulations.
This role is part of the External Quality Assurance (EQA) team responsible for product quality across a portfolio of topical skincare products that include Natural Health Products Cosmetics Homeopathic and Over the Counter (OTC) Drugs.
Responsibilities
Responsible for various aspects of quality assurance and quality control related to products produced.
Ensures that product is consistently manufactured in conformance with AbbVie Quality System requirements and all applicable regulatory requirements.
Supplier oversight assuring responsible Third Parties are complaint with cGMPs regulatory and corporate compliance requirements and contractual agreements as applicable.
Assist project teams in planning new product launches and tech transfer.
Ensure proper integration and support of quality regulations: drug biologics device and/or combination products.
Assist project teams in planning preparation review and approval of quality documentation. Responsible for developing a process to maintain citation history. Monitor changes to legislation regulations and statutes that may impact retention and/or require changes to the AbbVie Record Retention Schedule.
Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
Complete and route change requests for process document creation maintenance and implementation.
Design effective quality systems procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. 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 :
- 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 understate or local law:
The compensation range described below is the range of possible base pay compensation that theCompany believes in good faith it will pay for this role at the time of this posting based on the job gradefor this position. Individual compensation paid within this range will depend on many factors includinggeographic location and we may ultimately pay more or less than the posted range. This range may bemodified 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 vestedand determinable. The amount and availability of any bonus commission incentive benefits or any otherform of compensation and benefits that are allocable to a particular employee remains in the Companyssole and absolute discretion unless and until paid and may be modified at the Companys sole andabsolute 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
