QC Analyst II

at  Thermo Fisher Scientific

POSITION SUMMARY:

This role is responsible for the performing routine laboratory procedures, transfer/verification/validation of methodology, and project work within the department to support manufacture and release of pharmaceutical products.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

• Degree in Chemistry or strongly related scientific discipline
• Experience of instrumental and traditional analytical techniques.
• Ability to work to critical timelines with the ability to commit to overseas travel as part of a project team.
• A strong ability to build positive working relationships with both internal and external business customers and clients.
• Highly motivated and detail oriented individual with excellent communication, computer and organisational skills.

ABOUT US:

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued

• Perform quality control analytical testing of incoming goods, intermediates and/or finished products under cGMP conditions for QC release or as part of stability studies.
• Conduct technical transfer/method development/method validation as required
• Prepare technical documentation including but not limited to analytical write-ups, standard operating procedures, specifications, investigations and reports.
• Perform planned preventative maintenance and performance calibrations on equipment.
• Provide technical troubleshooting and problem solving related to analytical equipment, analytical methods or unexpected results
• Maintain own training records and support and train other team members as required.
• Communicate effectively with others on site and internationally, and to participate with them in problem solving activities.
• Ensure cGMP is applied and followed in all areas of the business.
• Work with HSE, cGMP and 5S in mind at all times including participation in continuous improvement activities looking for further opportunities to progress the team/department.
• Carry out any other tasks which may be required from time to time.
• Raw Material testing (includes instruments like FTIR, pH, UV-Vis, Density Meter, Karl Fischer).
• Testing to Pharmacopeia (USP and Ph. Eur. in particular, which are the American and European Pharmacopeia respectively).
• HPLC (preferable).
• Experience in writing Deviations, Out of Specifications, Change Controls.

EH&S:

• Understand emergency procedures and comply with safe systems of work.
• Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times
• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules