QC Analyst

• Adhering to all company EHS guidelines and procedures with proactive involvement in laboratory safety initiatives.
• Development and validation of laboratory test methods.
• Collaborate on the preparation and execution of the Project Validation Master Plan ensuring it is compliant with the relevant regulatory and Merck Millipore quality standards.
• Prepare validation and other related documentation, including protocols, SOPs, management procedures, etc.
• Execute protocols and compile reports generated from validation activities identified in the validation master plan.
• Train on laboratory procedures and develop onboarding plans for future analysts within the area.
• Lead analytical method development/troubleshooting for the project laboratory groups.
• Review of laboratory data where required, ensuring accuracy for all relevant product within the project scope.
• Validation of laboratory equipment, software, spreadsheets and methods.
• Perform validation, release, and non-routine testing as required.
• Support site commercialization readiness.
• Maintain lab fitness for audits.
• Ensuring compliance of the laboratory projects to all applicable quality, regulatory and Pharmacopeia requirements as well as all relevant divisional and corporate requirements.
• Work within Filtration FS2 laboratory calibration and preventative maintenance system.
• Provide technical support to all FS2 functional groups as required.
• Ensure laboratory project timelines are adhered to, and timelines are communicated with the laboratory supervisor.
• Ensure protocols, reports, test methods, SOPs and all other relevant documentation are drafted and approved prior to use.
• Ensure all laboratory investigations are completed in a timely manner and in accordance with site procedures.
• Ensure laboratory colleagues have full support for laboratory investigations and that standard root cause analysis tools are utilised.
• Contribute to risk mitigation initiatives such as FEMAs and risk assessments.
• Identify and participate in Continuous Improvement initiatives.
• Control, issue and maintain laboratory documentation. Archive laboratory data, logbooks and samples in accordance with procedures.
• Order, receive and control laboratory chemicals, reagents and consumables.
• Thorough investigation of quality and safety issues using root cause analysis methodology and implementation of robust corrective and preventative actions.
• Other duties as required.

• B.Sc. in Microbiology, Analytical Chemistry or related discipline.

• A minimum of 2 years practical work experience in Medical Device/Pharmaceutical environment. Experience in technical transfers would be an advantage.

• Strong background laboratory techniques
• Experience in LIMS, Trackwise, MES and SAP an advantage
• Experience in test method or equipment validation
• Lean Six Sigma Training (Yellow Belt, Blue Belt, etc.) an advantage
• Thorough, practical and persistent self-starter
• Strong motivation
• Good communication skills
• Good computer literacy
• Strong problem solving, organisational & time management skills

Merck Group