Senior Quality Specialist
Eurofins BioPharma Product Testing North America
Date: 4 weeks ago
City: Lancaster, PA
Contract type: Full time
Job Description
Applies GMP/GLP in all areas of responsibility, as appropriate
Monitor laboratory compliance with respect to expired reagents, reagent labeling, lab cleanliness, training records, PPE adherence, and other cGXP items, as needed to help minimize laboratory audit findings.
Perform/Support Internal audits, as well as help, implement the resolution of internal/external audit findings
Review Instrument qualifications to ensure that work is performed as per the procedure
Review and verify invalid data and system suitability failures
Review and close Exceptions under Non-Routine Events, System Suitability Failure, and Deviations
Approve Analytical Method/Protocol/SMIS/Client Parameter per QA procedure
Track and Analyze quality metrics (exception rate, rejection rate, etc) and train laboratory personnel, as needed, to help reduce/eliminate rework
Support other QA compliance-related activities, as needed
Diagnose problems, solve simple problems, and suggest solutions to complex problems in the professional area
Keep oneself and peers abreast of current developments and trends in the professional area by reading and understanding internal procedures, attending training sessions, by writing/revising SOPs (as required), and by assisting Group Leader/Principal Specialists in training new employees
Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
May serve as technical advisor for analysts with regard to QA/QC of data
Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns
Applies GMP/GLP in all areas of responsibility, as appropriate
Monitor laboratory compliance with respect to expired reagents, reagent labeling, lab cleanliness, training records, PPE adherence, and other cGXP items, as needed to help minimize laboratory audit findings.
Perform/Support Internal audits, as well as help, implement the resolution of internal/external audit findings
Review Instrument qualifications to ensure that work is performed as per the procedure
Review and verify invalid data and system suitability failures
Review and close Exceptions under Non-Routine Events, System Suitability Failure, and Deviations
Approve Analytical Method/Protocol/SMIS/Client Parameter per QA procedure
Track and Analyze quality metrics (exception rate, rejection rate, etc) and train laboratory personnel, as needed, to help reduce/eliminate rework
Support other QA compliance-related activities, as needed
Diagnose problems, solve simple problems, and suggest solutions to complex problems in the professional area
Keep oneself and peers abreast of current developments and trends in the professional area by reading and understanding internal procedures, attending training sessions, by writing/revising SOPs (as required), and by assisting Group Leader/Principal Specialists in training new employees
Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
May serve as technical advisor for analysts with regard to QA/QC of data
Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns
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