Intertek QA/QC Associate in Champaign, Illinois

This job was posted by : For more information, please see: QA/QC AssociateESSENTIAL DUTIES AND RESPONSIBILITIES:The QA/QC Associate is expected to have a complete understanding of FDA, ISO 17025, Good Laboratory Practices (GLP), and Good Manufacturing Practices (cGMP) under parts 110/111 and 210/211 as well as basic laboratory quality assurance procedures. By delegation from the QA/QC Manager and/or Site Director to provide, in a safe, legal, and ethical manner, the QA/QC and administrative functions to support the analytical and testing services of the LaboratoryRESPONSIBILITIES:? Become intimately familiar with company Standard Operating Procedures (SOPs), FDA regulations, ISO 17025 regulations, and other appropriate guidelines and regulations. Also be familiar with any sponsor SOPs that may apply to studies.? As designated and under supervision of QA/QC Manager or Site Director, perform OOS investigation in a timely manner according to the SOPs and customer's requirements. ? Properly document and maintain records of all OOSs. ? As designated and under supervision of QA/QC Manager or Site Director, interact with clients about complaints or other quality issues? Determine that no deviations from approved protocols/plans or standard operating procedures were made without prior authorization and documentation.? Assure compliance with cGMP regulations, ISO 17025 and company procedures (SOPs and QSMs).? Represent and interact with multiple departments to provide cGMP guidance in an effective manner.? Troubleshoot and take the initiative on any QA-related issues with regards to cGMP compliance.? As designated and under supervision of QA/QC Manager or Site Director, written reports of any corrective actions or preventive actions (CAPAs) investigated.? Assist with developing, revising, and reviewing SOPs.? Assist with performing quality review of drug and OOS results as well as review of ongoing studies..? Assist with maintaining training records of all employees.? Assist with performing facility inspections to ensure laboratory maintains compliance.? Support all other QA/QC functions as required.QUALIFICATIONS:The person for the position is expected to have at least BS degree in the field of Chemistry, Biological and Food Sciences or related fields with demonstration of competence in QA/QC knowledge through multiple years of analytical testing.PHYSICAL REQUIREMENTS:? Working in a laboratory known to contain potentially harmful chemicals.? Continuous sitting, upward and downward flexion of neck; fine finger dexterity and light to moderate finger pressure to manipulate keyboard, equipment controls, and other office equipment.? Long terms of standing to watching methods being done.? This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties.About IntertekIntertek offers a salary and benefit package competitively placed within the local market. We promote a culture where motivated, customer-oriented employees can flourish, experience professional fulfillment, and reach their highest potential. We offer medical, prescription, dental, vision, life and disability insurance plans, 401(k) with company match, paid time off (vacation, sick, holiday), Flexible Spending Account (FSA), Employee Assistance Program (EAP), tuition reimbursement, and more.We are an Equal Opportunity Employer a d do not discriminate against applicants due to veteran's status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.

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