Senior QC Analyst

Summary:

The Quality Control Senior Analyst is responsible for day-to-day operations related to release and stability testing, maintaining QC cell culture lines, and writing SOPs, deviations, change controls and CAPAs as part of typical QC operations.

Responsibilities:

• Performs GMP release and stability testing in Quality Control
• Write technical reports and supporting documentation such as deviation, reports, testing protocols, and trend analyses
• Review of laboratory notebooks, protocols and reports
• Perform day to day activities for cell propagation used for QC release and stability assays.
• Participate in technology transfer, method qualification and validation
• Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines
• Participate in internal assessments and regulatory audits as required
• Ensure that written records and work undertaken are performed in accordance with cGMP and company procedures
• Leading the lab in 5S and routine housekeeping activities
• Maintain effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing and Analytical Development
• Other duties as assigned

Requirements:

• Minimum of a Bachelor's degree or equivalent in a scientific discipline  
• Minimum 8 years of industry experience in a cGMP laboratory, preferably related to biopharmaceutical industry operations
• Hands on experience performing ELISA in a cGMP environment
• Hands on experience performing SDS-PAGE in a cGMP environment
• Working knowledge of Sf9 Insect Cell Culture Procedures and cell-based assays e.g. HS plaque and Rapid Titer assay
• GxP (regulatory relevant skills and knowledge) GLP/GCP/GMP required
• Excellent analytical skills and knowledge
• Strong troubleshooting skills for equipment and software
• Solid ability to work independently (minimum supervision)
• Ability to lead others, as needed
• Ability to effectively collaborate with others
• Excellent communications skills and be conversant in computer systems 
• Excellent multi-tasking and organizational skills.
• Excels in time management
• Strong attention to detail
• Job holder should be a good understanding of relevant regulatory/industry standards and requirements