Q&RA Engineer

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.