Register
Recruit Create CV
Unfortunately, this job posting is expired.
Don't worry, we can still help! Below, please find related information to help you with your job search.
Related keywords

Quality Control Analyst Jobs

Company

ABBVIE
Address , Irvine
Employment type FULL_TIME
Salary
Expires 2023-09-14
Posted at 8 months ago
Job Description
Overview
Coordinates and supports laboratory testing, product disposition including documentation and justification of nonconforming events, method validations, and prepares Laboratory/Validation reports. Requires knowledge and technical expertise of Microbiology, regulatory requirements and Global TrackWise system.
Responsibilities
  • Responsible for microbiology lab investigations. Extensive knowledge of Global TrackWise System and lab procedures, processes and methods.
  • Investigates all out-of-limit conditions and with the direct support from the QC Lab Manager implement a corrective action.
  • Prepares trend and metric laboratory reports in conjunction with the Microbiology Manager.
  • Performs, coordinates and supports method validations and prepares final reports documenting the validation findings.
  • Performs and coordinates microbiology testing release with the Final Quality Control Records maintained in SAP and LIMS.
  • Reviews and approves all laboratory testing documentation. Responsible for the preparation of Test Failure Investigation reports.
  • Receives and interprets the results of bioburden, microbial limits, environmental monitoring, growth promotion testing and sterility testing.
  • Must make sure that all laboratory supplies, inventory and on-going lab operations do not exceed a specified budget. Ensures that the correct and most updated versions of SOP’s are available to all laboratory personnel.
  • Responsible for leading others indirectly.
  • Reviews current regulatory and technical journals to help provide guidance and to support manufacturing regarding microbiological issues.


Qualifications
  • Advanced Microsoft Office and SAP user experience preferred. Knowledge of LIMS and Trackwise preferred.
  • Bachelor’s Degree in Microbiology or related Biological Sciences, with a minimum of three (3) years of lab experience.
  • Experience in the manufacture of pharmaceuticals with knowledge of water systems, clean rooms, and aseptic filling and process validation.
  • Experience working in a GMP regulated environment preferred. Audit experience preferred.
  • Two (2) years of experience in Industrial Microbiology with an emphasis in the Pharmaceutical and/or Medical Device industry, or equivalent experience. Knowledge of microbiology and regulatory requirements preferred.

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 including disability/vets. 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 disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.