Senior Quality Assurance Specialist

5 days ago

Deeside, Flintshire, United Kingdom ConvaTec Full time

Job Summary

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at ConvaTec. The successful candidate will be responsible for supervising a team of Chemical Analysts and ensuring the analytical chemistry laboratory operates in accordance with regulatory and procedural requirements.

Responsibilities

  • Assist the Laboratory Team Leader in supervising a small team of Chemical Analysts, ensuring day-to-day operations are conducted as per procedures and schedules.
  • Help the Laboratory Team Leader with the analytical team's workload and objectives.
  • Maintain equipment maintenance and calibration schedules.
  • Provide laboratory support for operations, plan testing schedules to ensure timely release of analytical chemistry.
  • Manage out-of-specification results, facilitate laboratory investigation reports, and involve the Laboratory Team Leader as needed.
  • Collect and trend data, react to trends, and report to the Laboratory Team Leader.
  • Maintain laboratory metrics.
  • 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 is maintained as directed by notified bodies regulations.
  • Comply with GMP standards and uphold these standards.
  • Comply with GLP standards and uphold these standards.
  • Responsible for identifying and introducing 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. Liaise with Rhymney 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, used to author technical reports and quality documents.
  • Demonstrates working in a fast-paced environment with changes embraced and implemented.
  • Knowledge of ISO standards and FDA regulations.
  • Knowledge of continuous improvement/quality assurance methods and techniques.

Qualifications/Education

  • Educated to degree level, or equivalent, within the Chemistry discipline.
  • At least 2 years' experience within an Analytical Chemistry laboratory.
  • Experience with ISO13485 and Pharmacopeia references.
  • Understanding of GMP and Quality Systems in a regulated environment.
  • In-depth knowledge of HPLC, ICP-MS, GC-FID, and AAS.

Travel Requirements

No travel required.

Language

English speaking, writing, and reading skills required.

Working Conditions

The successful candidate will work in a laboratory and clean room environment, as well as in an office, from 9:00 to 16:30 Monday to Friday. Must be available outside of work to support chemical analysts.

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