Senior Analyst, Quality Assurance, Onsite

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.

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 SOP’s and cGMP’s.
• Remain current on proper procedures by reviewing current, revised, and new SOP’s 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 company’s 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.

Education and Experience:

• A Bachelor’s 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.

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 role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors 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 is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are 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 and absolute discretion, consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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