Quality Control Analytical Team Leader
Plymouth
Medical Device
Permanent contract
Focus of the role
Supervise and effectively utilise the Quality Control Analytical Group resources to ensure timely and effective inspection and testing of raw materials, in progress, finished product, stability program and non-routine analytical requests according to approved documentation and Quality Management System requirements.
Role Responsibilities
- To ensure material and product quality conformity across the business.
- To ensure Quality Management System, Regulatory and Customer requirements
- for product quality are met.
- To ensure timely and effective provision of analytical test data and reports to support Production, R&D, Sales and Marketing and Quality Assurance functions
- Timely and effective inspection and testing of raw materials, work in-progress finished product, stability program and analytical requests.
- Timely and effective resolution of quality concerns including investigation of Out of Specification (OOS) results.
- No repeat occurrences of quality concerns with minimal OOS results attributed to analytical error.
- Accurate and timely reporting of test results.
- Safe and tidy laboratory environment with up-to-date Risk Assessments.
- Compliance with Quality Management System, Customer, GMP, GLP and Health & Safety requirements.
- To ensure quality control activities are performed in accordance with relevant AMS Health, Safety and Environmental policies and procedures.
- Ensure the accuracy of test data and reports prior to publication.
- Ensure timely investigation of Out of Specification (OOS) test results to determine and implement effective corrective and preventive actions.
- Participate and provide input into investigation of quality concerns arising from customer complaints, non-conforming materials, in-process non-conformances, and adverse data trends, including the identification of effective corrective and preventive actions.
- Develop and validate test methods to support new /changes to products and processes.
- Ensure current test methods utilised for product testing to support product release and registrations are validated and re-validated as required.
- Measure, statistically analyse and monitor product performance to identify adverse trends including stability program and test method performance providing clear and accurate reports.
- Manage stability program and initiate new studies as required.
- Set individual objectives for the QC Analytical staff and evaluate performance against objectives through the appraisal process.
- Provide and present data on team activities and performance to other functions and Management.
- Professionally represent the Quality Control Analytical Group during internal external and regulatory audits of the laboratory and associated areas.
- Perform internal audits as required.
- Maintain a clean, tidy and fit for purpose QC laboratory including maintenance of test materials, chemicals, reagents, standards, and equipment to ensure reproducibility and reliability of test results.
- Ensure stocks of materials, chemicals, reagents, and equipment required for QC inspection and testing are maintained and purchased against approved budget.
- Ensure timely and effective communication of the status of testing and quality concerns.
- Develop and deliver effective training program for the QC Analytical Group.
- Supervise, coach and mentor staff to continually develop a knowledgeable and skilled QC Analytical Group, ensuring up to date training records are maintained at all times.
- Ensure QC Laboratory procedures, test methods, statistical sampling plans and documentation is maintained to reflect internal and external requirements.
- Identify and progress continual improvement opportunities within the QC Analytical Group.
- Perform miscellaneous job-related duties as assigned by the Quality Manager
Qualification & skills
- Requires degree level in Chemistry or associated fields, or equivalent industry experience.
- Experience in testing, developing, and validating analytical test methods in a regulated environment
- Supervisory / line management experience
- Understanding of medical devices to the requirements of cGMP, CFR 21 Part 820, MDD 93/42/EEC and ISO 13458 or contract testing to requirements of GLP or ISO 17025
- Ability to identify material and product defects, which may adversely affect finished product safety, effectiveness, or quality
- Ability to operate and troubleshoot relevant testing instruments and equipment
- Ability to statistically analyse test results and generate accurate reports.
- Able to demonstrate achievement and continual improvement against key performance targets and Quality Objectives
- Ability to identify and implement continual improvement initiatives
- Knowledge of and experience in root cause analysis and problem-solving techniques
- Able to manage own time effectively, prioritise tasks, utilise resources effectively and deliver to critical deadlines and
- Excellent communication skills; written, verbal and presenting
- Certified Quality Auditor or Lead Auditor
- Project Management skills
- Keen attention to detail.
- Flexible and adaptable to changing work environment.
Salary & Benefits
Salary: £33,000 - £35,000 per annum
You'll receive competitive compensation and a fantastic benefits package including pension contribution of up to 6%, a yearly performance bonus, health care and life assurance and much more!
You'll be joining a friendly team that's open, flexible, and respectful of each other's differences. We understand that different perspectives bring fresh and unique insights to the mix