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Requires a BS with 2+ years experience in the biotechnology/medical device/pharmaceutical industry. Experience in cGMP manufacturing required.
Review the inspections of raw material documentation and responsible for release of materials for manufacturing use. Review of in-process documents and disposition of products. Provide Quality Assurance support for operations including final inspection of products. Periodically reviews and prepares procedures and specifications to ensure compliance to regulatory guidance. Provide training and technical leadership to less experienced staff. Participates in authoring complex and explicit documentation including SOP’s, Work Instructions, and other Quality documents. Involved in equipment IQ, OQ, and PQ.
Requires a AS+ with 0 to 5 years experience in the biotechnology/medical device/pharmaceutical industry. Experience in cGMP manufacturing a plus.
Duties and responsibilities will include: general laboratory operations including buffer and reagent preparation, instrument and equipment cleaning and maintenance, facility cleaning and washing of process equipment, sample handling, and the ability to follow strict quality standards and documentation (cGMP) all while maintaining a high level of quality and work integrity.