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Lead Quality Control Analyst

3 months ago

Deeside, Flintshire, United Kingdom ConvaTec Full time

About ConvaTec

ConvaTec is a pioneering global enterprise in medical products and technologies, dedicated to enhancing the quality of life for individuals with chronic conditions. Our expertise spans advanced wound care, ostomy care, continence care, and infusion care, with a workforce of approximately 10,000 professionals delivering solutions across nearly one hundred countries. We are committed to our mission of being forever caring, providing products that prevent infections, protect vulnerable skin, and improve patient outcomes while reducing healthcare costs.

Core Values

Our operations are guided by five fundamental values: Improve Care, Deliver Results, Grow Together, Own It, and Do What's Right.

Role Overview

The position of Senior QC Analyst involves serving as the site’s Chemical Testing Authority, overseeing a team of Chemical Analysts to ensure that the Analytical Chemistry laboratory adheres to the highest standards. This role requires ensuring compliance with regulatory and procedural requirements within controlled environments, offering technical support throughout the week.

Key Responsibilities

  • Assist the Laboratory Team Leader in managing a small team of Chemical Analysts, ensuring adherence to established procedures and schedules.
  • Support the Laboratory Team Leader in overseeing the analytical team's workload and objectives.
  • Maintain equipment maintenance and calibration schedules to ensure operational efficiency.
  • Provide laboratory support for operations, planning testing schedules to ensure timely release of analytical chemistry results.
  • Manage out-of-specification results and facilitate laboratory investigation reports, collaborating with the Laboratory Team Leader as necessary.
  • Collect and analyze data trends, reporting findings to the Laboratory Team Leader.
  • Maintain laboratory performance metrics and inventory of consumables.
  • Ensure waste disposal complies with EHS guidelines.
  • Utilize the SAP business system to facilitate product release processes.
  • Ensure compliance with regulations set by notified bodies.
  • Uphold GMP and GLP standards consistently.
  • Identify and implement continuous improvement opportunities within the laboratory.
  • Support testing requests and project work as needed.
  • Conduct method validations and maintain validation of analytical chemistry test methods.
  • Ensure operational equipment is maintained in a validated state.
  • Apply knowledge of analytical equipment for repairs and preventative maintenance.
  • Collaborate with supply chain and vendors to address non-conformances.
  • Support root cause investigations in conjunction with Quality Assurance.

Key Requirements

  • Experience in a quality system within a complex, regulated manufacturing environment.
  • Proficiency in data management and interpretation of datasets.
  • Strong written communication skills, with experience in authoring technical reports and quality documents.
  • Ability to thrive in a fast-paced environment, demonstrating enthusiasm and initiative in driving improvements.
  • Familiarity with ISO standards and FDA regulations.
  • Knowledge of continuous improvement and quality assurance methodologies.
  • Experience in coaching and mentoring laboratory technicians.

Qualifications

  • Degree or equivalent in a Chemistry-related discipline.
  • A minimum of 2 years’ experience in an Analytical Chemistry laboratory.
  • Familiarity with ISO13485 and Pharmacopeia references.
  • Understanding of GMP and Quality Systems in a regulated setting.
  • In-depth knowledge of HPLC, ICP-MS, GC-FID, and AAS techniques.

Working Conditions

This role involves working in both laboratory and clean room environments, as well as in an office setting. Standard working hours are Monday to Friday, with a structured break schedule. Availability outside of regular hours to support chemical analysts is expected.

At ConvaTec, we offer numerous opportunities for professional growth and development. Embrace the chance to drive your own progress and make a significant impact in your career.