QC Analyst II

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials, 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.,

• 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
  
  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.
  
  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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . 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.