- BSc or higher with 5+ years in lab quality assurance
- Lab experience and investigations experience for OOS and Deviations
- Knowledge of the CAPA process as it relates to lab data
- Manage CAPA process for the site; Investigate Out of Specification results (OOS); improve and measure improvement to quality and efficiency.
- Perform root cause analysis for Out of Specifications, Deviations, Complaints and CAPAs
- Provides guidance to OOS results investigations on a daily bases where SOP and regulatory guidelines are followed; Provides guidance to operations on how to write the OOS; reviews and approves OOS investigations; Provides support in OOS investigations to sequence of events and root cause analysis. Approves OOS hypothesis testing, repeat test and final OOS Investigation according to internal SOP.
- Decides on CAPA plans for OOS.
- Performs CAPA /Complaints process. Investigates CAPAs of QA. Participates in CAPA; investigations if requested by CAPA owner. Reviews, approves CAPAs according to CAPA SOP
- Plots the C of A incorrect %/sample /total samples per month for root cause analysis; Uses Pareto chart / risk analysis for scheduling corrective action and improvement to number of correct C of A;
- Reviews stability protocols as per client requests and communicates effectively with clients if required;
- Performs QA Review/ approval of methods
- May review validation protocols or reports;
- May performs review of calibration records;
- Review clients Certificate of Analysis and / or Stability Protocols/ Validation Protocols / Reports and approve before submission and / or provide to the Department Head for submission to the client;
- Ensure that client requests and complaints are dealt with effectively;
- Experience in the review and issuance of C of A and in the responsibilities noted above
- Bachelor of Science degree in Chemistry, Biochemistry, Biology, Microbiology or College with minimum 5-10 years QA review and QC lab experience
- Knowledge of OOS Investigation regulatory process;
- Some QC lab experience and definitely Investigation experience for OOS and Deviations.
- Knowledge of scientific principles pertaining to analytical records reviewed
Laboratory Quality Assurance - InvestigationsToronto, ON, Canada
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Laboratory Quality Assurance - Investigations
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001413
Date Posted: 09/08/2019