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Lead Quality Control Analyst
2 months ago
About ConvaTec
ConvaTec is a pioneering global enterprise in medical products and technologies, dedicated to enhancing the quality of life for individuals managing chronic conditions. Our focus spans advanced wound care, ostomy care, continence care, and infusion care, with a workforce of approximately 10,000 professionals delivering our services across nearly one hundred countries. We are united by a commitment to care, aiming to provide solutions that enhance patient outcomes while reducing healthcare costs. In 2022, our group revenues exceeded $2 billion, and we are proud to be part of the FTSE 100 Index (LSE: CTEC).
Core Values
Our operations are guided by five core values that shape our daily activities: Improve Care, Deliver Results, Grow Together, Own It, and Do What's Right.
Role Overview
The position of Senior QC Analyst is essential for overseeing the Chemical Testing division. This role involves supervising a team of Chemical Analysts to ensure that the Analytical Chemistry laboratory adheres to required standards and complies with regulatory and procedural mandates. The successful candidate will ensure compliance within controlled environments and provide technical support throughout the week.
Key Responsibilities
- Assist the Laboratory Team Leader in managing a small team of Chemical Analysts, ensuring adherence to procedures and schedules.
- Support the Laboratory Team Leader in overseeing the analytical team's workload and objectives.
- Maintain schedules for equipment maintenance and calibration.
- Provide laboratory support for operations and plan testing schedules to ensure timely release of analytical chemistry results.
- Manage out-of-specification results and facilitate laboratory investigation reports, involving the Laboratory Team Leader as necessary.
- Collect and analyze data trends, reporting findings to the Laboratory Team Leader.
- Maintain laboratory performance metrics.
- Control stock orders and manage inventory of laboratory consumables.
- Ensure waste disposal complies with EHS guidelines.
- Utilize the SAP business system to facilitate product release.
- Ensure compliance with regulations set by notified bodies.
- Uphold GMP and GLP standards within the laboratory.
- Identify and implement continuous improvement opportunities within the lab.
- Support testing requests and project work.
- Conduct method validations and maintain operational equipment in a validated state.
- Apply analytical equipment knowledge 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.
- Familiarity with data management and interpretation of datasets.
- Strong written communication skills for authoring technical reports and quality documents.
- Ability to thrive in a fast-paced environment, driving and implementing new initiatives.
- Knowledge of ISO standards and FDA regulations.
- Understanding of continuous improvement and quality assurance methodologies.
- Experience in coaching and mentoring laboratory technicians.
Qualifications/Education
- Degree or equivalent qualification in Chemistry.
- 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 environment.
- In-depth knowledge of HPLC, ICP-MS, GC-FID, and AAS.
Working Conditions
This role involves working in both laboratory and clean room environments, as well as in an office setting. The standard working hours are Monday to Friday, with a structured break schedule. Availability outside of regular hours to support chemical analysts is expected.
Equal Opportunities
ConvaTec is committed to providing equal employment opportunities for all employees and applicants, ensuring no discrimination based on race, religion, gender, or any other protected characteristic.
