Senior Analyst, Quality Assurance - Irvine, CA
Senior Analyst, Quality Assurance - Irvine, CA
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Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
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.
Additional Qualifications/Responsibilities
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.
Salary: $82500 - $157500
Required Experience:
Senior IC
Employment Type
Full Time
