QC Analyst II *PC 610

Responsibilities

• Develop and execute environmental monitoring in ISO5/7/8 clean rooms
• Develop and execute microbiological assays, such as sterility
• Adhere to all applicable SOPs for clean rooms, quality control and quality assurance
• Develop GMP documentation such as, trend reports, SOPs and documents to support equipment operation
• Ensure proper maintenance and use of equipment in strict accordance with cGMPs, SOPs and safety policies
• Lead EM Investigations
• Serve as a key resource as it relates to establishing EM testing requirements
• Trend EM Data and investigate all OOL specifications
• Identify counts and assist in investigating and implementing appropriate CAPA
• Work with QA, Manufacturing, Development and others to troubleshoot issues
• Ensure adherence to EM schedule
• Develop and Implement training plans for QC EM Analyst I on the EM Program
• Train manufacturing and QA team members on EM program requirements
• Ensure quality standards are always met or exceeded
• May assist in audits

Requirements

• B.S. Biology, Chemistry, Biotechnology, or related field; 2+ years of experience in environmental monitoring
• Knowledge of cGMP or GLP regulations is essential
• Comprehensive GMP environmental monitoring experience is required
• Previous experience working in QC department of Biotech Company is preferred
• Impeccable aseptic technique
• Experienced with MS Office specifically, Word, Excel and PowerPoint

Physical Demands

• Regularly required to walk, use hands to finger, handle, or feel, reach with hands and arms, talk, and hear
• Occasionally lift and/or move up to 25 pounds
• Must have close vision, color vision, peripheral vision, depth perception and ability to adjust focus
• Exposed to viruses and bacteria

Work Environment

• Temperature-controlled facility without exposure to extreme hot or cold temperatures
• Clean laboratory setting
• Routine use of standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers
• Exposure to noise level in the work environment is usually moderate