QA Specialist

Renaissance LLC


Job Description
Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The QA Specialist role is to review manufacturing batch records, testing results and deviation reports for compliance with cGMP and company procedures with minimal supervision. To release products, drug product components and container-closures. To review and write cGMP procedures under supervision. To report periodic quality metrics. The ability to read, write and speak English is a requirement of the job. Responsibilities • Review manufacturing batch records, testing results and deviation reports • Interact with other departments to address review observations • Release drug product, drug product components and container-closures • Interact with customers on batch record reviews and batch releases • Attend department meetings on batch record review and releases • Maintain and report quality metrics on batch record review and releases • Review and write standard operating procedures • Review quality system documents (change controls, validation, complaints) • Review master batch records and maintain records • Process, investigate and follow-up on product complaints • Perform other tasks as requested by management. Qualifications Bachelor's Degree (BA or BS), preferably in a Natural Science, is required. A minimum of 3 years of relevant experience in the pharmaceutical industry is required. PI184258674
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