QC Analyst

Overview

This role involves delivering extensive analytical chemistry support to the Site Quality Control lab, ensuring the precise, compliant, and prompt analysis of raw materials, intermediates, and finished products. The position plays a key part in batch release and maintaining superior quality standards.

Responsibilities

• Execute various analytical techniques such as ELISA, UV/VIS Spectroscopy, Osmolality testing, Oxygen Headspace analysis, SDS-Page, Biacore receptor binding, Moisture assessment via Karl Fischer, and particulate analysis using HIAC.
• Ensure critical chemical testing and associated equipment are validated and conform to qualification requirements (IQ, OQ, PQ).
• Maintain and revise chemical testing methods, specifications, and SOPs to comply with pharmacopoeial and regulatory standards.
• Daily review and audit of chemistry test outcomes to verify conformance with cGLP and cGMP guidelines.
• Examine laboratory notebooks and analytical reports for completeness and accuracy.
• Keep quality documentation and records fully updated and compliant.
• Timely conduct of Out of Specification (OOS) investigations and record findings in Certificates of Analysis (COAs).
• Ensure all laboratory operations uphold Good Laboratory Practice (cGLP) standards continuously.
• Collaborate effectively with Quality Assurance, Production, Engineering, and Planning teams on issues related to materials and batch releases.
• Inform the QC Team Leader of potential issues and suggest process enhancements through routine communication.
• Support training activities for colleagues on expertise areas, new methods, SOP implementations, and updates.
• Analyze trends in analytical data and maintain records on COAs as required.

Candidate Requirements

• Demonstrated experience in a GMP/GLP regulated Quality Control environment.
• Comprehensive understanding of pharmacopoeial and regulatory compliance requirements.
• Exceptional attention to detail alongside strong documentation capabilities.
• Proven skills in conducting effective OOS investigations.
• Hands-on experience with instrumentation including Softmax software, Karl Fischer titration, HIAC particulate analysis, and UV/VIS spectroscopy.
• Expertise in micro-pipetting technique and analytical methods such as ELISA, Osmolality, Oxygen Headspace, SDS-Page, and Biacore receptor binding.
• Background in equipment validation and qualification processes (IQ, OQ, PQ).
• Strong organizational and time management skills to meet deadlines.
• Excellent communication skills for liaising across functions.
• Ability to work independently and collaboratively within a team.
• A proactive mindset focused on problem-solving and continuous improvement.