Quality Assurance Team Lead

4 weeks ago


Swindon, Swindon, United Kingdom Thermo Fisher Scientific Full time

Job Summary:

As a key member of our Quality Assurance team, the QC Section Head will be responsible for ensuring the highest standards of quality in our laboratory operations. This role requires a strong background in analytical chemistry and a proven track record of leadership and problem-solving.

Key Responsibilities:

  • Serve as the first point of escalation for technical, compliance, and personnel problem resolution.
  • Lead, plan, and coordinate routine team activities to meet business needs.
  • Perform QC Chemistry analysis of incoming goods, in-process samples, intermediates, and finished product samples to Good Manufacturing Practice (GMP) standards.
  • Conduct GMP analysis of stability samples.
  • Complete, update, and review technical documentation, including analytical write-ups, standard operating procedures, and GMP forms.
  • Verify and calibrate lab equipment.
  • Maintain up-to-date training in line with GMP expectations.
  • Manage QC chemical, reference standard, and consumable stock levels.
  • Perform or coordinate QC batch release procedures and deliver lab throughput in line with the business plan.
  • Manage and coordinate stability studies in compliance with business procedures and ICH guidelines.
  • Maintain a thorough understanding of international regulatory requirements and act as a Subject Matter Expert during audits and inspections.
  • Collaborate and coordinate initiatives with other QC Supervisors and Managers for improved compliance, efficiency, and working conditions.
  • Identify and drive Practical Process Improvement (PPI) initiatives.
  • Undertake ad-hoc activities as required by the business.
  • Support and encourage a 'Quality Culture' throughout QC.
  • Deputize for the QC Manager in their absence.

Requirements:

  • Degree in Chemistry or a strongly related scientific subject area, or equivalent experience.
  • At least five years of relevant industrial experience.
  • Extensive experience in instrumental and traditional analytical techniques.
  • Supervisory experience is desirable.
  • Effective communication skills at all internal and external levels.
  • Proficient time management and project management skills.

At Thermo Fisher Scientific, we are committed to accelerating research, solving complex scientific challenges, and supporting patients in need. If you are a motivated and experienced professional looking to make a difference, we encourage you to apply for this exciting opportunity.



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