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 Resume to HR Dept., Katalyst Healthcares & Life Sciences, Inc., at hr@katalysthls.com
We are currently hiring
Quality Analysts
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 Science, Engineering, Pharmacy, Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Mechanical Engineering, Industrial Engineering, Regulatory Affairs, Public Health, or related field along with six (6) months of experience in the job offered or related occupation is required. Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S
Clinical Data Analysts
Responsibilities : Perform all aspects of data management, statistical programming, analysis & reporting of clinical data deliverables. Create appropriate databases, datasets. Data validation, discrepancy management, extraction and database lock. Develop, review and manage key study documents like data management & validation plans, statistical analysis plans (SAP), protocols, CRF, TMF, SAE, SOPs and their audit. Perform QC/validation of Clinical Development activities like UAT, edit checks, SAS programmed checks, data review, coding, lock process. Create tables, listings & graphs (TLG).
Requirements : Master’s degree in Science, Engineering, Pharmacy, Clinical Research, Biochemistry, Biotechnology, Regulatory Affairs, Health Informatics, Public Health, Information Systems Engineering & Management, or related field along with six (6) months of experience in the job offered or related occupation is required. Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.