Senior Quality Assurance Specialist

5 days ago

Deeside, Flintshire, United Kingdom ConvaTec Full time
Job Summary

We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at ConvaTec. As a key member of our Analytical Chemistry Laboratory, you will be responsible for ensuring the highest standards of quality and compliance in our operations.

Key Responsibilities
  • Supervise a team of Chemical Analysts and ensure the day-to-day operations of the laboratory are conducted in accordance with procedures and schedules.
  • Assist the Laboratory Team Leader in managing the analytical team's workload and objectives.
  • Maintain equipment maintenance and calibration schedules to ensure optimal performance.
  • Provide laboratory support for operations, plan testing schedules, and ensure timely turnaround of release for analytical chemistry.
  • Manage out-of-specification results, facilitate laboratory investigation reports, and involve the Laboratory Team Leader as necessary.
  • Collect and trend data, react to trends, and report to the Laboratory Team Leader.
  • Maintain laboratory metrics and ensure compliance with regulatory requirements.
  • Control stock orders and maintain inventory of consumables.
  • Maintain waste disposal in line with EHS guidelines.
  • Utilize the SAP business system to facilitate product release.
  • Ensure compliance with GMP and GLP standards and uphold these standards.
  • Identify and introduce continuous improvement opportunities within the lab.
  • Support request testing and project work.
  • Perform method validations.
  • Adhere to legal, corporate, and site legislation.
  • Maintain validation of analytical chemistry test methods.
  • Ensure maintenance of operational equipment within the lab.
  • Apply knowledge of analytical equipment to perform repairs and preventative maintenance.
  • Collaborate with supply chain and vendors to resolve non-conformances.
  • Support root cause investigations and liaise with Quality Assurance.
Requirements
  • Successful participation in a quality system in a complex and regulated manufacturing environment.
  • Experience with data management and interpretation of data sets.
  • Excellent written skills, with experience in authoring technical reports and quality documents.
  • Demonstrated ability to work in a fast-paced environment, embracing change and implementing new initiatives.
  • Knowledge of ISO standards and FDA regulations.
  • Knowledge of continuous improvement and quality assurance methods and techniques.
  • Coaching and mentoring of laboratory technicians.
Qualifications/Education
  • Educated to degree level, or equivalent, within a Chemistry discipline.
  • At least 2 years' experience within an Analytical Chemistry laboratory.
  • Experience of ISO13485 and Pharmacopeia's references.
  • Understanding of GMP and Quality Systems in a regulated environment.
  • In-depth knowledge of HPLC, ICP-MS, GC-FID, and AAS.

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