Associate Specialist, Quality Systems

The Associate 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.
• Perform quality review of quality system and computerized system changes.
• Perform quality review of specifications associated with drug biologics device and/or combination products.
• Complete and route change requests for process document creation maintenance and implementation.
• Support project teams in planning preparation review and approval of quality documentation.
• Collect and compile key quality metric data.

• Participate in training and education programs for various aspects of quality assurance.

Qualifications :

• Bachelors Degree (Chemistry Pharmacy Biology Microbiology Engineering or other technical/ scientific area preferred) or equivalent experience.
• 0-2 years experience in quality assurance quality oversight or relevant experience.
• Knowledge and familiarity with product process equipment and facilities of pharmaceutical biological and medical device products preferred.
• Strong oral and written communication skills needed.
• Excellent interpersonal skills a plus.
• Delivers tactical results to support the quality system.

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 roleat  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors  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 isearned  vested  and determinable. The amount and availability of  any bonus commission incentive benefits or any other form of compensation and benefits thatare 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 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. 

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Work :

No

Employment Type :

Full-time