Senior Analyst, Quality Assurance

Location: Irvine
Posted on: June 23, 2025

Job Description:

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 This is a key quality assurance role reporting to the Quality Assurance Manager. This position performs as a Senior Analyst in Quality Assurance oversight of operations, production, process and equipment systems and computer validation at the Bioscience Laboratories Irvine (BLI). This position is responsible for one or more of the following duties or activities: Provide QA oversight of operational activities, production, validations, and Technical Services projects. Ensure that QA systems and manufacturing/engineering systems undergo an independent assessment to eliminate any potential conflict of interest between ownership and administration. Review and approve Quality System documents: SOPs, validation and technical protocols/reports. Review and approve Laboratory and Non-conformance Investigations. Manage the review and approval of master batch records, executed batch records, manufacturing data, release testing data, and stability data, ensuring compliance with AbbVie data integrity guidelines. Support change management activities associated with equipment, method and process validations. Perform all assigned duties according to departmental SOPs and cGMPs. Remain current on proper procedures by reviewing current, revised, and new SOPs relating to the job and to the department. Participate and take quality lead on process improvement projects. Provide support for the inspection and release of drug substance, process aids, disinfectants, and raw materials. Assist AbbVie in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies. Incumbent has full authority to make decisions and/or take actions required to carry out job duties. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements, and objectives. The incumbent must be willing to take temporary assignments as required. Regulated Responsibilities (including cGMP and EHS): AbbVie is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC,and ADA. Incumbent will work to ensure that the companys compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate. Qualifications Education and Experience: A Bachelors degree is required. Preferred individuals with Chemistry, Biochemistry, or a closely related discipline. 5 8 years of Quality systems experience within Biotech or Biopharmaceuticals environment is highly desired IT System: Strong user of LiMS, Microsoft Office Suite, Maximo, SAP, TrackWise Regulatory: Prefer experience in a cGMP regulated environment Quality: Prefer experience in Quality Systems Essential Knowledge, Skills and Abilities: Ability to handle a wide variety of tasks under time constraints. Ability to interpret multiple standards and apply to department activities. Ability to interpret and evaluate data and summarize results. Knowledge and good understanding of validation. Knowledge of regulatory requirements for data integrity Be open to taking new approaches to establish and maintain effective relationships with coworkers and subordinates. Proficiency in data management software and tools. Ability to work in a Windows computer environment. Excellent analytical, problem-solving, oral and written skills. 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 ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay 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/visioninsurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of payis considered to bewages 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 benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay 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 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

Keywords: , Lancaster , Senior Analyst, Quality Assurance, Healthcare , Irvine, California