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Oncothyreon Inc Message Board

  • biomachine2006 biomachine2006 Nov 19, 2012 10:41 AM Flag

    EMD Serono Canada

    Job Description

    Senior Quality Control Analyst-1205002
    EMD Serono, Inc. is a leader in the U.S. biopharmaceutical industry. We have more than 1,000 employees throughout the United States with fully

    POSITION TITLE: Senior Quality Control Analyst
    REPORTS TO: Manager, Quality Control
    LOCATION: Edmonton, Alberta
    POSITION TYPE: Permanent, Full Time

    Performance of routine and non-routine analysis of raw materials, in process, and finished formulations according to standard operating procedures (SOP’s) to ensure conformity to standards and specifications
    Plan, schedule and coordinate in-house and external testing of raw materials, in-process and final products
    To support analytical and biological team activities ensuring consistency with company strategy, commitments and goals
    Holds the position as Quality Control Senior Analyst directly reporting to the Quality Control Manager

    Main Interfaces
    Quality Assurance
    Pharmaceutical Development
    Analytical Development

    Contract Test Laboratories


    Functinoal Knowledge and GMP Related Activities
    Adherence to all GMP regulations applicable to the function at the Edmonton site.

    Adherence to all applicable local SOP’s as trained
    Monitoring, completion and documentation of the training requirements as noted in the training matrix and/or training plans.
    Perform analytical and biological testing as required based on applicable training
    Operation and maintenance of lab equipment including, but not limited to, analytical balances, HPLC, GC, pH meter, UV/VIS spectrophotometer, particle size analyzer, Spectramax plate reader
    Review routine testing results

    Troubleshoot equipment issues and call on outside vendors, if necessary

    Draft and update SOP’s, protocols and reports

    Complete all necessary aspects of the documentation, change control, and deviation management programs as they apply

    Involvement in new lab equipment, IQ,OQ and PQ’s

    Provide training and technical leadership

    Monitor that equipment PM’s and calibrations are completed within required timeframes

    Routine laboratory cleaning and maintenance

    Purchase of reagents and materials in SAP

    General housekeeping activities (checking expired reagents, reading temperature monitoring printouts, etc.) at required intervals and according to approved procedures

    Maintain and update training file as required

    Problem Solving
    Support the company functions involved in GMP activities to build a culture based on problem solving

    Interpersonal Skills
    Support the Quality Control Department to internal and external departments as well as other companies, vendors and consultants.

    Special Projects
    Support the Quality Control Department for the coordination, implementation and execution of projects by liaison with QC Project Manager


    Bachelor’s Degree/Technical College in area of scientific expertise

    Good knowledge on manufacturing, quality control and development activities in a GMP environment
    Five (5) years of pharmaceutical industry experience, including significant experience in biotechnology product manufacturing
    Minimum 2 years experience with HPLC & GC analytical testing considered an asset, preferably within a pharmaceutical environment

    Strong teamwork and decision making skills
    Good written and verbal communication skills
    Organized and able to function in a rapidly changing environment and balance multiple priorities simultaneously
    Knowledge of quality standards (Canada/EU/FDA) in GxP (GMP, GLP) and ICH Q10
    Key Competencies:
    · Teamwork
    · Communication with Impact
    · Results Orientation
    · Customer Orientation
    · Change and Innovation
    This position reports to (Title): Quality Control Manager
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