Quality Control Scientist I
875 Research Parkway Meriden, CT
Provides contributions to the coordination of Stability program in Quality Control department including schedulling following protocols, assistance in writing protocols and reports, assembly testing results and performing data analysis. Understanding and interpretation of results from Stability Studies and how they impact on the design of subsequent experiments. Designs, executes, and interprets experiments to develop, validate, transfer and troubleshoot quality procedures and test methods related to stability program. Carries out investigations and produces documentation for Out of Specification, Out of Trend and Deviations for the Stability Program. Develops and authors complex, explicit documentation for new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics. Solves assay/process problems. Identifies potential problems and proactively suggests technical solutions based upon analytical expertise and knowledge of product/process. Routinely coordinates completion of specific project tasks with other departments. Contributes to development of project strategy in consultation with supervisor and/or colleagues. Work is performed under minimal supervision. Independently determines and develops approach to solution. Work is reviewed upon completion for adequacy in meeting objectives. Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in program delays and expenditure of resources. Frequent inter-organizational contacts.
At least 3 years experience in a cGMP laboratory setting with experience in analytical methods development/implementation/troubleshooting. Experience in management of stability program including stability statistical analysis.
Advanced degree (Master of Science, doctorate) in a scientific discipline in areas related to production of Biopharmaceuticals such as Biochemistry, Molecular Biology, Chemical Engeneering, Pharmacy.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.