Senior QA Associate I

Job Description

Job Description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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.

Bachelor’s 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)

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 Company's sole and absolute discretion unless and until paid and may be  modified at the Company’s 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 -us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

-us/reasonable- accommodations.html