We are constantly on the lookout for dedicated, talented and experienced individuals to add to value to our Organization.
If you think you have the skills and experience what we are looking for the following positions, Please send us your resume to HR Dept., Katalyst HealthCares & Life Sciences Inc., 285 Durham Avenue, Suite 12, South Plainfield, NJ 07080.
We are currently hiring
Responsibilities : Involve in the design, development, implementation, testing, documentation & support of cGxP systems as per 21 CFR Part 11 & US FDA. Responsible for qualification & validation (IQ/OQ/PQ), master plans, protocols, changes requests, gap & root cause analysis, risk management plans, traceability matrix, summary reports for facilities, equipment, systems & processes. Preparation, review, authorize & submission of documentation for quality compliance & regulatory authorities.
Requirements: Master’s degree in pharmacy, biotechnology, chemistry, biochemistry, chemical engineering, mechanical engineering, industrial engineering, biomedical engineering, regulatory affairs, health informatics or related field with 6 months of experience in job offered or related occupation is required. Bachelor's degree in the above fields along with 5 years of experience in job offered or related occupation is acceptable in lieu of Master’s degree plus 6 months of experience. Any suitable combination of education, training or experience is acceptable. Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.
Responsibilities : Perform all aspects of data management. Ensure quality and timely completion of data management deliverables. Create appropriate databases and data quality assurance. Resolve data queries. Create specifications for data review plans and develop protocol deviation specifications. Review and manage key study documents like management plans, protocols, CRF, TMF, SAE and their audit. Perform quality control of Clinical Research Organization (CRO) activities like UAT, edit checks, coding, lock process. Write standard operating procedures (SOP).
Requirements: Master’s degree in Pharmacy, Biotechnology, Clinical Research Administration, Medicine, Biochemistry, Regulatory Affairs, Health Informatics or related field with 6 months of experience in job offered or related occupation is required. Bachelor's degree in the above fields along with 5 years of experience in job offered or related occupation is acceptable in lieu of Master’s degree plus 6 months of experience. Any suitable combination of education, training or experience is acceptable. Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.