Specialist, Quality Systems
Specialist, Quality Systems
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
The Specialist Quality Systems 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.
Responsibilities:
- Assist with 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.
- Complete and route change requests for process document creation maintenance and implementation.
- Create quality system documentation and specifications with guidance from technical teams following approved templates and guidelines.
- Assist with or colead audits of documentation facilities and equipment.
- Assist in the design of effective quality systems procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
- Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
- Participate in 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.
- 3 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 preferred.
- Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting device biologics and pharmaceutical products preferred.
- Experience working in both team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
- Strong oral and written communication skills needed.
- Excellent interpersonal skills a plus.
- Runs small projects to deliver tactical results.
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
