SalaryUSD $35 - $40 per hour 35 - 40 per hour
Title: Contract QA Stability CoordinatorLocation: Lexington, MADuration: 10+ Month contractAbout the Company: A global biotechnology company focused on serving people with rare diseases and other highly specialized conditions.Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.About the Role: This person will be supporting day to day- stability data consolidating into global databases and reporting it out to staff. Reports/ presentations/ working closely with senior members to consolidate effort. Support Specialists in the Project Management of Stability Studies for Drug Products, Drug Substances, and Intermediates as well as associated Data Evaluations and Documentation. Your Main Responsibilities:
- 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