Quality Assurance and Compliance Officer
Salary competitive (negotiable depending on experience) + Benefits
We are hiring for a Quality Assurance and Compliance Officer for our client based in Bristol to join their QC and Development team. They have been working within small molecule manufacture for over 30 years (supplying life science and clinical research laboratories) and are part of a multi-national company with a global footprint. The company is currently moving into a more diverse market and as such this is an exciting time to get on board.
This position, reporting to the Quality Manager, is part of a small Quality Assurance team within a company currently developing its Quality Systems for GMP and RUO production of life science reagents. This is an exciting opportunity for a QA Officer to help implement, establish and maintain Systems in their early development.
What you’ll do:
Key responsibilities for the Quality Assurance and Compliance Officer role:
- Training system: Maintenance of the site Training System and organise / participate in internal quality related training sessions.
- Documentation Management: Writing, reviewing and approving internal procedures. Release and issuance of procedures and archiving previous revisions.
- Change Control: Participation in the change control process to ensure all changes to procedures and processes are assessed and implemented correctly.
- Non-conformance: Coordinate and approve/manage to completion any non-conformances, deviations, out of specifications and observations.
- 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.
- Internal Audits: Participation in the completion of the internal audit schedule.
Conducting the internal audits, reporting any findings and tracking completion of corrective actions.
- Batch Record review and product release: Review, approval and release of Batch Production Records and Quality Control testing data.
- Supplier Quality: Assist in the implementation of a process of QA approval of incoming materials and approval of QC testing for incoming materials.
- Regulatory issues: To ensure compliance with relevant UK and EU regulations governing the purchasing, storage, use and sale of regulated products and raw materials.
- Technical Support: Providing technical support as required to customers and resolving any associated customer complaints.
- Working as part of the ISO 9001:2015 implementation team.
- Any other task as required by the business
For the Quality Assurance and Compliance Officer role:
- BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
- Minimum 2 years’ experience of working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company.
- Minimum 2 years’ experience of working within a cGMP environment.
- Experience of working to ISO 9001, ISO 13485 or 21CFR part 820.
- Experience of documentation management systems and change control processes.
- Carrying out internal audits.
- Carrying out training to SOPs.
- Critical review of CAPA / non-conformances / deviations / OOS.
- Conducting final batch release.
- Involvement in supplier quality processes.
- Experience of relevant UK and EU regulations governing the purchasing, storage, use and sale of regulated products.
- Customer complaints or technical support experience.
- Excellent team working skills.
- Ability to critically review documentation.
- Methodical, process orientated and highly organised approach.
- Excellent attention to detail.
- Excellent time management skills.
- Excellent verbal and written communication skills.
- Excellent problem solving ability.
- Flexible, can-do attitude
Salary range for the Quality Assurance and Compliance Officer role is flexible and will be commensurate with skills and experience of successful candidate.
To apply for the Quality Assurance and Compliance Officer role:
Cover notes supporting your application are welcomed. On this occasion LiCa Scientific is acting as an employment agency.
Please email email@example.com with your most up to date CV and a cover letter.
Should you be keen to have an informal conversation ahead of application please email firstname.lastname@example.org and we’ll be happy to set this up.