Quality Assurance Officer

4 days ago

Bristol, United Kingdom LiCa Scientific Ltd Full time

**Quality Assurance Officer**

**Bristol**

**Permanent role**

**£30-£38k**

We are working with a global life sciences company where you will have an impact on cutting edge research in Life Sciences and Clinical Diagnostics. They are based in Bristol and committed to product quality, customer satisfaction, continuous improvementmínimalizing environmental impacts and conserving natural resources. They are seeking a Quality Assurance (QA) Officer to add to their team.

**What you’ll do**:
You will cover all-areas of the clients QA operations related to this, and work in a 4-person team. The site works to ISO 90001 and 21 CFR 820 and ISO 13485.
- 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.
- 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.
- 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: Review, approval and release of Batch Production Records and Quality Control testing data.
- Training: Organise and participate in internal quality related training sessions
- 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**:
**A small list of essential requirements are**:

- BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
- 2 years’ experience of working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company.
- 2 years’ experience of working within a cGMP environment.
- Experience of working to ISO 9001, ISO 13485 or 21CFR part 820.

**The following will be desirable**:

- 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

If you are in doubt we suggest send in your CV and we can set up a call to discuss this, alternatively we are available to call in working hours every weekday.

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

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