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AMRI Quality Assurance Specialist II in WEST LAFAYETTE, Indiana

Title: Quality Assurance Specialist II Location: US-IN-West Lafayette Job Number: 1003472

QUALITY SPECIALIST II in West Lafayette, IN AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. The Quality Assurance Specialist II is an integral part of the AMRI team, contributing to our success by performing cGMP review of lab operations to ensure appropriate reports/data/processes to conform with SOP's and guidelines. Role serves as important function to maintain appropriate regulatory documentation. Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. In this role, you will: Perform QA audits of scientific reports/data to ensure cGMP compliance in preparation for release of the reports to the customer Develop, implement, and revise procedures (SOPs, Methods, etc.) Conduct investigations and internal audits of quality systems Review equipment and software qualification and validation protocols Participate in client audits and regulatory inspections by escorting auditors and securing requested documents and data Designs and plans audits of simple quality systems for review with QA management Conducts employee training sessions as necessary Qualifications: Qualifications and background to be successful in this role: BS degree (chemistry or other related scientific field preferred) Demonstrated proficiency in oral and written communication skills producing effective interaction with others at all levels All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply. Other Locations:

EOE Protected Veterans/Disability

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