Job description
Q&RA Engineer
Location: Basingstoke, with occasional on-site attendance required (approximately once per month for meetings)
Pay Rate: £23.50 per hour
We are currently recruiting for a Q&RA Engineer to join a fast-paced and highly regulated manufacturing environment. This role will focus on providing quality oversight through documentation review, process monitoring, investigation support, and collaboration with cross-functional teams to ensure compliance and continuous improvement across quality systems.
This is a 9-Month contract with the possibility of an extension.
Key Responsibilities:
- Provide support and maintain compliance with GMP/GxP, ISO, and regulatory requirements
- Investigate quality issues and support root cause analysis activities
- Manage and support change control processes
- Conduct and support internal and external audits and regulatory inspections
- Author and review quality documentation including SOPs, investigation reports, and related records
- Perform data analysis, trending, and reporting of quality metrics
- Collaborate with cross-functional teams to drive corrective and preventive actions (CAPA)
- Support continuous improvement initiatives and quality system enhancements
Education & Experience:
- Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field with 5+ years' experience in Quality Assurance or Quality Control
- Alternatively, an advanced degree with 3+ years of relevant experience
- Previous experience within regulated industries such as pharmaceutical, medical device, or biotechnology environments preferred
- Experience working with Quality Management Systems, CAPA processes, deviation management, and change control
- Strong understanding of investigation techniques, root cause analysis, and corrective action implementation
- Experience supporting or hosting internal/external audits and regulatory inspections
- Knowledge of statistical analysis, data trending, and quality metrics reporting
- Project management experience beneficial
Knowledge, Skills & Abilities:
- Strong understanding of GMP/GxP regulations and ISO standards including ISO 9001/13485
- Knowledge of risk assessment methodologies and continuous improvement tools
- Strong technical writing skills for SOPs, investigation reports, and quality documentation
- Excellent problem-solving skills and attention to detail
- Strong verbal and written communication skills
- Ability to collaborate effectively across teams and departments
- Comfortable working within manufacturing environments and using PPE where required
- Ability to work independently while supporting cross-functional teams
Brook Street NMR is acting as an Employment Business in relation to this vacancy.
