Job Title: Quality & Regulatory Affairs (Q&RA) Engineer I (2 Positions Available)
- Location: Basingstoke (Remote with 1x month on-site meeting attendance)
- Pay Rate: 23.50 per hour
- Contract Duration: 9 months initially (40 hours per week)
- Start Date: ASAP
Position Overview
Are you looking to make a meaningful impact on a global scale? We are seeking two high-performing Q&RA Engineers to join a collaborative team dedicated to developing solutions for some of the world's toughest challenges.
In this role, you will ensure quality compliance across operations, providing essential quality oversight through detailed documentation reviews, process monitoring, and close collaboration with cross-functional teams. This is a fantastic opportunity to maintain compliance, investigate quality events, and drive continuous improvement initiatives for life-changing products.
Key Responsibilities
- Compliance & Audits: Support and maintain compliance with GMP/GxP, ISO, and regulatory requirements. Conduct and support internal/external audits and regulatory inspections.
- Investigations & CAPA: Investigate quality issues, lead root-cause analysis efforts, and collaborate across teams to drive corrective and preventive actions (CAPA).
- Documentation & Change Control: Author and review critical quality documentation (SOPs, investigation reports, etc.) and manage change control activities.
- Data & Metrics: Perform data analysis, trending, and reporting of quality metrics to support continuous improvement.Requirements & Qualifications
Education:
- Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field with 5+ years of experience in QA/QC OR an Advanced degree with 3+ years of relevant experience.
Experience:
- Proven background in regulated industries (Pharmaceutical, Medical Device, or Biotech preferred).
- Hands-on experience with Quality Management Systems (e.g., Document Control Systems), CAPA processes, deviation management, and change control.
- Demonstrated expertise in root cause analysis and investigation techniques.
- Experience conducting and hosting internal/external audits.
- Proficiency in statistical analysis, data trending, and quality metrics reporting.
- Project management experience is highly preferred.
Knowledge, Skills & Abilities:
- Strong knowledge of GMP/GxP regulations and ISO standards (9001/13485).
- Familiarity with risk assessment methodologies and continuous improvement tools.
- Excellent technical writing skills for authoring SOPs and investigation reports.
- Advanced problem-solving abilities, high attention to detail, and excellent communication skills.
- Ability to work independently, guide cross-functional teams, and work in manufacturing environments with appropriate PPE as needed.
Interview Process
- Stage 1: 30-minute initial interview.
Note: A standard background check is required for the successful candidate.
Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.
Candidates must be eligible to live and work in the UK.
For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.