Senior Analyst Quality Assurance Onsite
Senior Analyst Quality Assurance Onsite
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Not Disclosed
Salary Not Disclosed
1 Vacancy
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 Nonconformance 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 SarbanesOxley 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 problemsolving 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 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 shortterm 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 Companys sole and absolute discretion unless and until paid and may 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 serving our community and embracing diversity and inclusion. It is AbbVies 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.
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No
Employment Type :
Fulltime
Employment Type
Full-time
