SalaryUSD $35 - $40 per hour 35 - 40 per hour
- Support ongoing stability programs and objectives
- Support compilation and analysis of stability data for compliance to end of shelf life expectations
- Support operational activities related to stability quality systems, including Discoverant, LIMS, and other software applications
- Support the analysis of and detection of stability alerts (OOTs)
- Support the development and training initiatives of statistical applications for stability management
- Support data analysis activities, including trending of stability data for multiple products
- Authoring of technical documents
- Supporting ongoing activities in EQMS systems including (LIMS, Discoverant, and others)
- Conducts work in compliance with cGMPs, safety and regulatory requirements
- Typically requires Bachelor in Science or Engineering or several years of Experience in pharmaceutical Industry Science related degree is preferred GMP data stability, understanding quality systems in the GMP background.
- PHARMA experience is important.
- Experienced in GMP regulations and compliance requirements
- Knowledge and understanding of ICH and other regulatory requirements.
- Experience with various quality systems (e.g. LIMS)
- Relevant experience with pharmaceutical pipeline products and CMC aspects of regulatory filings.
- Experience in Discoverant or other statistical software (e.g. JMP, Minitab) a plus
- Scientific knowledge in protein / plasma / antibody chemistry / small molecule products