QC Team Leader (Cimanggis)

Abbott·
Indonesia - Depok
1mo ago
Full-time

Description

<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>JOB DESCRIPTION:</b></h2><p><span>Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.</span></p><p></p><p><b><span>MAIN PURPOSE OF THE ROLE</span></b></p><div><ul><li><p><span><span>Perform<span> </span></span><span>QC<span> </span></span><span>instruments<span> </span></span><span>qualification</span><span>.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>C</span><span>oordinate<span> </span></span><span>the<span> </span></span><span>activities<span> </span></span><span>of<span> </span></span><span>Test Method Development</span><span>,<span> </span></span><span>Test Method Validation / Verification,<span> </span></span><span>T</span><span>est<span> </span></span><span>M</span><span>ethod<span> </span></span><span>T</span><span>ransfer,<span> </span></span><span>testing of<span> </span></span><span>process validation and cleaning validation</span><span><span> </span>samples</span><span>.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Perform compendial review activities to ensure<span> </span></span><span>QC<span> </span></span><span>compliance</span><span><span> </span></span><span>state</span><span>.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Support QC Manager in coordinating<span> </span></span><span>QC Laboratory Operational Continuous Improvement programs</span><span>.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Perform QC Laboratory<span> </span></span><span>Testing<span> </span></span><span>Function</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Perform as QC Reviewer Function, including daily QC coordination and scheduling activity.</span></span><span> </span></p></li></ul></div><p><br /><b><span>MAIN RESPONSIBILITIES</span></b></p><p></p><div><div><p><span><span>1. Performs Physical and Chemical Test Activities</span></span><span> </span></p></div><div><ul><li><p><span><span>Perform analysis for incoming material/ Intermediate/ finished product accordingly and generate laboratory worksheets and the report accurately and completely</span><span>.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Perform chemical testing on stability program</span><span>.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Record<span> </span></span><span>reagents</span><span><span> </span>stocks, and make sure all<span> </span></span><span>reagents</span><span><span> </span>stock is well<span> </span></span><span>maintained</span><span>, and all are within its expiry date.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Calibrates all of<span> </span></span><span>equipment</span><span><span> </span>used in<span> </span></span><span>lab</span><span><span> </span>according to<span> </span></span><span>defined</span><span><span> </span>schedule.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Verify Equipment calibration status is available, clear and all are within calibration schedule.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Coordinate test method validation and method transfer</span><span>.</span></span><span> </span></p></li></ul></div><div><p><span> </span></p></div><div><p><span><span>2.  Performs Laboratory<span> </span></span><span>Compliance<span> </span></span><span>Function and support</span></span><span> </span></p></div></div><div><div><ul><li><p><span><span>Perform compendial review program to ensure the compendial method and/or monograph<span> </span></span><span>applied at the sites are following the current compendia.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Run plans to<span> </span></span><span>identify</span><span>,<span> </span></span><span>monitor</span><span><span> </span>and implement continuous improvement programs of QC Laboratory Operations.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ensure that<span> </span></span><span>related</span><span><span> </span></span><span>copy BOP</span><span><span> </span>of</span><span><span> </span>each laboratory equipment/instrument is available and attached in the related logbook and ensure all are followed.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ensure that laboratory equipment/instruments logbook equipment is filled accurately as per its BOP, completely reviewed and available near to the equipment.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Perform inspection of laboratory<span> </span></span></span><span><span>facility related to floors, walls, and ceilings of smooth, hard surfaces that are clean and no deterioration</span><span>.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ensure laboratory housekeeping is well<span> </span></span><span>maintained</span><span>.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ensure that balance water pass is in the<span> </span></span><span>center</span><span><span> </span>position</span><span>.  </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ensure that all glassware is clean from residue and sticker label. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Actively involved in<span> </span></span><span>maintaining</span><span><span> </span>laboratory compliance program in Laboratory</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Ensure laboratory housekeeping is well<span> </span></span><span>maintained</span><span>. </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Actively<span> </span></span><span>participated</span><span><span> </span>in Continuous Improvement program in Laboratory</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Performs duties as assigned by QC Supervisor or QC Manager effectively and efficiently.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Participates in investigating any problem and<span> </span></span><span>participates</span><span><span> </span>in solving out the<span> </span></span><span>problem</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Obligates and responsible for good cooperation, work discipline, work safety and safety environment in laboratory, implement and<span> </span></span><span>maintain</span><span><span> </span>laboratory compliance, keep confidentially of all documents, and achievement on definite yearly goals.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Perform stability testing and monitoring<span> </span></span><span>program</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Perform QC Equipment Qualification/Calibration<span> </span></span><span>program</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Perform QC Test Method Development and Validation or Method Transfer<span> </span></span><span>activities</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Verify raw data and worksheet generated during testing to ensure raw data completeness and correct calculation.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Coordination sampling activity with sampling technician and verify worksheet if the responsible leader is absent.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Coordinate lab activities, incoming raw material testing activities,</span></span><span><span><span> </span>finished product and stability product if the responsible leader is absent.</span></span><span> </span></p></li></ul></div></div><div><div><p><span> </span></p></div><div><p><span><span>3</span></span><span><span>.  Perform as QC Reviewer Function</span></span><span> </span></p></div><div><ul><li><p><span><span>Review and verify all QC raw data and worksheet generated by QC Analyst and Lab Technician for all type of QC Physical and Chemical testing performance.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Review and verify all QC raw data and worksheet generated by QC Analyst for QC Equipment Qualification</span></span><span><span>/Calibration and Test Method Development and Validation</span></span><span> </span></p></li></ul></div></div><p></p><p><b><span>QUALIFICATIONS</span></b><br /> </p><div><ul><li><p><span><span>3</span><span><span> </span>Years’ experience as QC Analyst from Chemical Analyst High School or </span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Bachelor’s degree majoring in Chemistry or Pharmaceutical Science</span><span>.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>Knowledge of continuous improvement skills and methodologies.</span></span><span> </span></p></li></ul></div><div><ul><li><p><span><span>English literacy.</span></span><span> </span></p></li></ul><p></p><p><span>Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.</span></p></div><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p><b>The base pay for this position is </b></p>N/A<p style="text-align:left"><span>In specific locations, the pay range may vary from the range posted.</span></p><p style="text-align:inherit">     </p><h2><b>JOB FAMILY:</b></h2>Operations Quality<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>DIVISION:</b></h2>EPD Established Pharma<p style="text-align:inherit">&nbsp; &nbsp; &nbsp; &nbsp;&nbsp;</p><h2><b>LOCATION:</b></h2>Indonesia &gt; Depok : Cimanggis QA/Labs<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>ADDITIONAL LOCATIONS:</b></h2><p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>WORK SHIFT:</b></h2>Standard<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>TRAVEL:</b></h2>No<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>MEDICAL SURVEILLANCE:</b></h2>No<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><h2><b>SIGNIFICANT WORK ACTIVITIES:</b></h2>Not Applicable<p style="text-align:inherit">&nbsp; &nbsp; &nbsp;</p><p style="text-align:inherit">     </p><p style="text-align:inherit">     </p>
Abbott

Abbott

BIOTECHNOLOGY

Device Manufacturing

LocationABBOTT PARK, IL
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