AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.
The Sr. Quality Assurance Specialist is an integral part of the AMRI team, contributing to our success by ensuring compliance with cGMPs, Company and customer quality standards as well as external regulatory requirements.
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.
Perform internal and external audit and develop programs and prepare reports as required. Participate in the Annual Quality Systems audit program. This includes the preparation of Audit Plans, conducting audits and writing Audit reports.
Assist with Regulatory and Customer audits as required. Assist in preparing and provide assigned audit responses to observations.
Develop and maintain a thorough understanding of cGMPs and associated regulations. Apply this knowledge in the everyday work environment, providing consultation as necessary. Actively participate in resolving quality issues. Make suggestions for quality system improvements and recommend methods to increase the quality of products and/or services. Participate in the implementation of these improvements.
Review and approve master and production batch records. Assist in the development of records with operations as needed.
Disposition of final intermediates and APIs (includes review of all associated documentation).
Create, Review and approve deviations and investigations. Function as QA lead for Quality Events. Compile data, prepare and review trends. Identify areas of concern and communicate to management.
Create, review and approve change controls.
Create, review and approve material release specifications and certificates of analysis.
Review and approve equipment qualification documentation, including protocols and reports.
Review and approve SOPs. Write SOPs as required.
Assist in resolving quality problems/concerns with quality control and manufacturing personnel.
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