Q&RA Engineer
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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: xsngvjr
* 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.