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Palatin Technologies, Inc. Quality Assurance Manager in Cranbury, New Jersey

Quality Assurance Manager. Palatin Technologies, Inc. Cranbury, NJ. Manage the development, implementation and maintenance of quality assurance systems and activities; work collaboratively with our partners at our Contract Manufacturing Organizations (CMOs) and regularly lead meetings to discuss issues and seek continuous improvement across systems; review contractor batch records, assess, and resolve quality issues, assist in final disposition of clinical and commercial products, and perform data and documentation reviews and analyses to assure finished products conform to government, company standards, and satisfy GMP and FDA regulations; Develops and revises SOPs and oversees the generation and review of documents including internal and contract manufacturer documentation to ensure GxP compliance; Develops and maintains audit programs, performs audits of contract manufacturers and vendors, prepares reports of audit findings and initiates, and monitors and enforces corrective action necessary to assure conformity to quality specifications; Keeps abreast of regulatory procedures and ensures the development and implementation of SOPs to maintain compliance. Need MS degree in Pharmaceutical Manufacturing or a pharmacy related field of study. Need 2 yrs. as a Quality Manager or related role with a pharmaceutical company or an R&D company or BioTech company. Need 2 yrs. working with regulatory requirements (e.g., FDA or EU Regulations) and 2 yrs. experience with submissions. Need 2 yrs. exp. with R&D and commercial batch disposition and review of GMP documents. Need 2 yrs. exp. with GMP Process, CMO oversight, and Quality Systems. Applicants can apply by sending resume to hr@palatin.com.

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