Q&RA Engineer

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