Quality Laboratory Analyst

Job Description

Title: Quality Lab AnalystIndustry: Medical DevicesLocation: Plymouth, DevonPosition Type: Full-Time, Permanent PositionAbout The CompanyYou will be joining an organisation who specialise in the design, development, manufacture and distribution of novel, high performance tissue-healing technologies, including advanced wound care products, surgical dressings, and medical grade materials aswell as medical adhesives and sutures for closing and sealing tissue.Job DescriptionOverviewAs a Quality Lab Analyst, you will play a crucial role in ensuring the highest standards of quality and compliance in the production of medical devices. The position involves performing various analytical and testing procedures to verify the quality of materials,components, and finished products. The successful candidate will work closely with cross-functional teams to uphold regulatory requirements, maintain documentation integrity, and contribute to the continuous improvement of product quality.Key Responsibilities

• Perform routine analytical analysis on GC/MS, GC-FID, HPLC instrumentation as well as water content analysis using Karl Fischer titration.
• Mentor/ provide guidance and training on lab procedures and practices when required.
• Protocol and report writing
• Responsible for in-process inspection and testing for goods inwards as well as formulated product.
• Responsible for operations stability analytical testing ensuring sensitive time points are achieved.
• Route cause analysis laboratory testing for NC/CAPAs.
• Maintenance and troubleshooting of analytical instrumentation.
• Ensuring that Good Manufacturing Practice (GMP) is always maintained.
• Following and maintenance of SOPs and Process Work Instructions (PWIs)
• Ensuring recorded results are accurate and all records are maintained to GMP standards.
• Supporting QA with day-to-day tasks.
• Responsible for conducting other QC/QA related functions.
• Responsible for ensuring Device History Files are maintained.
• Any other reasonable requirement needed to meet business objectives.

Qualifications

• Bachelors degree in a relevant scientific field such as biology, chemistry, biochemistry, or a related discipline.
• Minimum of 1-2 years of experience in a laboratory setting, preferably in a medical device manufacturing environment.
• Proficiency in working with laboratory instruments and equipment relevant to the medical device industry, such as HPLC, GC, FTIR, and other analytical instruments. HPLC & GC experiences is a must have requirement.
• Experience with analytical techniques and methods used in quality control and assurance.
• Familiarity with relevant regulatory standards and guidelines, such as ISO 13485 and FDA regulations pertaining to medical devices.
• Strong documentation skills with the ability to maintain accurate and detailed records of laboratory procedures, test results, and equipment maintenance.
• Knowledge of quality management systems and the ability to implement and adhere to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

Salary & Benefits£28,000 per annumCompetitive salary and benefits package.Opportunities for professional growth and development.A supportive and collaborative work environment.Contribution to the improvement of healthcare through cutting-edge medical technology.How to ApplyApply now by submitting your CV below, alternatively you can send your CV to . Please include "Quality Lab Analyst" in the subject line.