Senior QA Associate I
AbbVie
Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
Purpose:
Primarily responsible for carrying out tasks related to core job responsibilities by providing quality consultation, auditing and the coordination of projects to maintain and improve the quality of work-related processes.
Responsibilities:
- Carry out job duties, by planning, organizing, and leading study-specific inspections and/or internal system/process-based audits.
- 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.
- Provide Peer Review and/or approval for Audit Plans, Audit Schedules, and Audit Reports.
- 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 will be a hybrid schedule, onsite at our Lake County Headquarters.
Qualifications
- Bachelor’s degree, preferably in life sciences or engineering.
- Thorough understanding of GLP regulatory standards.
- 2+ years’ experience in function or related fields, such as, toxicology, bioanalytical laboratory, analytical chemistry, clinical pathology, Quality Assurance and/or Regulatory Affairs.
- Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ) Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA).
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Interpersonal and communication skills and ability to work independently and as part of a team
- Have a team-oriented work style and strong collaboration skills.
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, vested,and 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 Company'ssole 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html