Quality Assurance Officer

Job Description

Quality Assurance Officer Permanent role Bristol Salary to £40,000 + package (competitive pension, private medical, generous holidays, income protection scheme/critical illness cover) Our client is a cutting edge research company working across the life sciences and clinical diagnostics areas.They are seeking a Quality Assurance Officer (QA) who will work on product quality, customer satisfaction, continuous improvement, environmental impact minimisation and other QA fields.What you’ll do: Our client is a world-leading developer of life science reagents, and you will be joining a QA team of four which is currently in place. The role will work in a defined segment of the business on activities detailed below, covering Quality Assurance tasksrelating to development and manufacture of Good Manufacturing Practice / GMP and Research Use Only / RUO products.This is an exciting opportunity for a QA Officer to help maintain the current Quality Systems as well as get involved in continual improvement of these systems.Key Responsibilities will include:

• Batch Record review and product: Review, approval and release of Batch Production Records and Quality Control testing data.
• Non-conformance: Coordinate and approve/manage to completion any non-conformances, deviations and out of specifications.
• CAPA: Coordinate and approve/manage to completion any CAPA raised. Ensure adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly.
• Documentation Management: Writing, reviewing, and approving internal procedures. Release and issuance of procedures and archiving previous revisions.
• Change Control: Review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly.
• Training: Organise and participate in internal quality related training sessions.
• Internal Audits: Participation in the completion of the internal audit schedule. Conducting the internal audits, reporting any findings, and tracking completion of corrective actions.
• Supplier Quality: Assist in the QA approval of incoming materials and approval of QC testing for incoming materials.
• Technical Support: Providing technical support as required in relation to customer enquiries and supporting any associated customer complaint investigations.
• Any other task as required by the business.

Your Background:

• Degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
• Experience of working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company.
• Experience of working within a cGMP environment is a top-line requirement for this role (please do detail your experience in your application or covering information).
• Experience of working to ISO 9001, ISO 13485, 21CFR part 820 or EudraLex Volume 4, Part II.

Further desirable skills we seek:

• Experienced in conducting final QA product release
• Experienced in the critical review of Corrective and Preventative Actions / CAPA / non-conformances / deviations / Out Of Specification OOS
• Experienced in documentation management systems and change control processes from a Quality Assurance perspective

• Experienced internal auditor for ISO 9001, ISO 13485 or cGMP
• Experienced in supplier quality processes
• Experienced in investigation of customer complaints and customer technical support
• Experience of relevant UK and EU regulations governing the purchasing, storage, use and sale of regulated products

• Excellent team working skills
• Ability to critically review documentation
• Methodical, process orientated and highly organised
• Excellent attention to detail
• Excellent time management skills
• Excellent verbal and written communication skills in English
• Problem solving ability
• Flexible with a can-do attitude

On this occasion, LiCa Scientific is acting as an employment agency.

Keyskills :
BiotechnologyChemistryGMPQuality Assurance