QC Analyst-Shift

PSC Biotech is a leading Biotech Consultancy firm with a permanent contract of employment offering exposure to working in Top Pharmaceutical client sites in a diverse-cultural work setting. The QC Analyst role involves supporting internal customers by delivering high quality, compliant test results in accordance with GMP standards.

Requirements

• Perform primary review of QC raw data and trend results
• Prepare protocols, summaries, and reports, including documents submitted directly to pharmaceutical regulatory agencies
• Draft and update QC Standard Operating Procedures (SOPs)
• Act as a technical subject matter expert (SME) and provide training and support to other analysts in areas of expertise
• Evaluate analytical and microbiological results against defined acceptance criteria
• Conduct and document laboratory investigations through to completion
• Maintain the laboratory in a constant state of audit and inspection readiness
• Interact directly with regulatory agency inspectors during audits and inspections
• Interface with other functions including Manufacturing, Quality Assurance, Facilities, and external contractors as required

Benefits

• Empowering career development through Learning & Development in-house training mentorship
• Opportunity to work with the most talented cohort of like-minded professionals
• High performing teams that can exceed client expectations