Quality Laboratory Investigator
Quality Laboratory Investigator
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Job Description
Purpose
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 QC lab investigations. Extensive knowledge of Global TrackWise System and lab procedures processes and methods.
- Performs coordinates and supports method validations and prepares final reports documenting the validation findings.
- Receives and interprets the results of QC testing.
- Investigates all outoflimit conditions and with the direct support from the QC Lab Manager implement a corrective action.
- Reviews and approves all laboratory testing documentation.
Responsible for the preparation of Test Failure Investigation reports. - Performs and coordinates QC testing release with the Final Quality Control Records maintained in SAP and LIMS.
- Responsible for leading others indirectly.
- Prepares trend and metric laboratory reports in conjunction with the Microbiology and Chemistry Managers.
- Must make sure that all laboratory supplies inventory and ongoing lab operations do not exceed a specified budget. Ensures that the correct and most updated versions of SOPs are available to all laboratory personnel
- Reviews current regulatory and technical journals to help provide guidance and to support manufacturing regarding microbiological issues.
Qualifications :
- Bachelors Degree in Life Sciences with a minimum of three (3) years of lab experience.
- Two (2) years of experience in QC with an emphasis in the Pharmaceutical and/or Medical Device industry or equivalent experience. Knowledge of microbiology chemistry and regulatory requirements preferred.
- Advanced Microsoft Office and SAP user experience preferred. Knowledge of LIMS and Trackwise preferred
- Experience in the manufacture of pharmaceuticals with knowledge of water systems clean rooms and aseptic filling process validation and analytical testing.
- Experience working in a GMP regulated environment preferred. Audit experience preferred.
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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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
