Laboratory Quality Assurance - Investigations

    Toronto, ON, Canada
    • 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

    Kelly Scientific Resources believes in relationships, not transactions. That’s why we’re committed to successfully matching job seekers with the best employers across Canada and around the world.  We fill positions from entry level to senior management, on a temporary or permanent basis. Whether your specialty is Science, Engineering, IT, Finance, Marketing, Manufacturing, Contact Centre or Business Administration, we’ll work with you to understand your likes, dislikes, goals and ambitions, and present you with opportunities that meet your needs. See what we have to offer.

    Looking for more?  Sign up for our Career Tips Newsletter to receive helpful tips and tricks monthly, connect with us on Facebook, LinkedIn & Twitter, or visit kellyservices.ca.

    Kelly Services (Canada) Ltd., is committed to providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

     

    Laboratory Quality Assurance - Investigations

    • 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;

    Knowledge needed:

    • 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

    Category: Biotechnology & Pharmaceutical

    Reference ID: CA7677BM001413

    Date Posted: 09/08/2019

    Shortcut: http://jobs.en.kellyservices.ca/RZBsXQ

    Connect with Us
    Powered by SnapHop