Senior QA Associate I

Purpose:
Primarily responsible for carrying out tasks related to core job responsibilities by providing quality
consultation auditing and coordination of projects to maintain and improve the quality of work-related
processes.

Responsibilities:
Carryout job duties by planning organizing and leading study-specific inspections and/or internal system/process-based audits. Requires some supervisory oversight.

• Review raw data protocols and research reports to assure the quality and integrity of the results as well as compliance to protocols policies procedures and applicable governmental regulations; and be able to evaluate the potential risk of compliance deficiencies.
• Provide guidance and training on GLP regulations and guidelines to Associate GLP auditors and functional area personnel.
• Assist the Inspection Management group on inspections by regulatory agencies.
• Prepare and present project progress reports to update management and keep the team(s) informed.
• Participate on cross-functional project teams
• This is an independent quality assurance auditor position. The individual is expected to demonstrate decision-making ability. However this is a skills-mastering position with supervisory review and oversight.

This role is a hybrid role with onsite at our Lake County Headquarters.

Qualifications :

Bachelors degree preferably in life sciences or engineering.

• 4 years experience in function or related fields such as toxicology bioanalytical laboratory analytical chemistry clinical pathology Quality Assurance and/or Regulatory Affairs.
• General understanding of GxP regulatory standards.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ)
  Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA)

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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time