QC Senior Analyst

Work Your Magic with us! 
 
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimaginable with us.

The Role

Reporting to the FS2 Laboratory Supervisor, the Senior Analyst is responsible for coordination of routine and non-routine testing in QC Laboratory to support release of product from manufacturing areas.

The Senior Analyst will perform all activities in an efficient and competent manner with due regard to safety and quality, while ensuring a positive team environment and a focus on continuous improvement.

Duties

•    Adhering to all company EHS guidelines and procedures with proactive involvement in laboratory safety initiatives.
•    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.
•    Validation of laboratory equipment, software, spreadsheets and methods.
•    Coordination of validation, release and non-routine testing as required.
•    Provide back-up for laboratory testing to support manufacturing areas.
•    Support development and validation testing as required.
•    Support site commercialization readiness.
•    Training of laboratory, production and contract personnel and develop onboarding plans for future analysts within the area.
•    Lead analytical method development/troubleshooting for the project laboratory groups.
•    Troubleshooting of laboratory equipment.
•    Processing laboratory investigations for atypical or out-of-specification results and leading RCA investigations. Ensuring all laboratory investigations are completed in a timely manner and in accordance with site procedures.
•    Responsibility for purchasing and maintaining inventory levels in the laboratory.
•    Maintain the laboratory calibration and preventative maintenance system/schedules.
•    Review of laboratory data and reports, ensuring accuracy for all relevant product within the project scope.
•    Draft and update procedures, protocols, reports and quality documentation.
•    Contribution to continuous improvements in the laboratory.
•    Contribute to risk mitigation initiatives such as FEMAs and risk assessments.
•    Provide technical support to all FS2 functional groups as required, including support for process validations, quality improvement initiatives and customer complaints.
•    Ensuring compliance of the laboratory projects to all applicable quality, regulatory and Pharmacopeia requirements as well as all relevant divisional and corporate requirements.
•    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 laboratory colleagues have full support for laboratory investigations and that standard root cause analysis tools are utilised.
•    Responsible for compliance with all applicable Quality and EHS procedures.
•    Thorough investigation of quality and safety issues using root cause analysis methodology and implementation of robust corrective and preventative actions.
•    Maintain lab fitness for audits.
•    Other duties as required.

Who You Are

B.Sc. in Analytical Chemistry, Microbiology 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
• Good attention to detail

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!