At a Glance
- Tasks: Ensure compliance and drive quality improvements in a regulated environment.
- Company: Join a leading firm focused on innovation and quality in life sciences.
- Benefits: Enjoy remote work flexibility with just one onsite visit per month.
- Other info: Fast-track interview process and commitment to diversity and inclusion.
- Why this job: Make a real impact in quality assurance while working from home.
- Qualifications: Bachelor's degree and 5+ years in QA/QC within regulated industries.
Location: Basingstoke (Remote / 1x Month Onsite)
Pay Rate: £27.00 per hour
Hours: 40 hours per week (Monday - Friday)
Contract Duration: 9 Months initially
Are you a technical Quality professional with a passion for compliance, data integrity, and continuous improvement? We are seeking a Q&RA Engineer II to join our team on an initial 9-month remote contract. This high-level role is ideal for a self-driven engineer who thrives on technical problem-solving, detailed documentation review, and cross-functional collaboration within highly regulated manufacturing environments.
Key Responsibilities:
- Compliance Management: Maintain and support strict compliance with global GMP/GxP regulations, ISO 9001/13485 standards, and internal quality system metrics.
- Investigations & CAPA: Lead root cause analysis (RCA) efforts for localized quality events and deviations, implementing robust corrective and preventive actions.
- Change Control & Auditing: Manage day-to-day change control workflows, update internal documentation (SOPs, investigation logs), and support internal and external quality audits.
- Data Trending: Perform statistical analysis, quality metric reporting, and trend mapping to drive operational excellence.
Requirements:
- Education: Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field.
- Experience: 5+ years of quality assurance/control (QA/QC) experience in a regulated setting (Pharmaceutical, Medical Device, or Biotech strongly preferred).
- Systems: Solid proficiency with electronic Quality Management Systems (eQMS) such as MasterControl or TrackWise.
- Skills: Strong technical writing skills for authoring regulatory compliance logs, advanced problem-solving abilities, and the capacity to work independently.
What We Offer:
- Work-Life Balance: A primarily work-from-home, autonomous schedule requiring only one travel day per month to our Basingstoke site.
- Fast-Track Process: A streamlined interview cycle consisting of a single, 30-minute conversation with the hiring manager.
Randstad CPE values diversity and promotes equality. 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.
Quality & Regulatory Engineer II in Basingstoke employer: Randstad Engineering
Join a forward-thinking company that prioritises work-life balance and offers a flexible remote working environment, with only one required onsite visit per month in Basingstoke. As a Quality & Regulatory Engineer II, you will thrive in a culture that values continuous improvement and compliance, while benefiting from streamlined hiring processes and opportunities for professional growth in a highly regulated industry.
StudySmarter Expert Advice🤫
We think this is how you could land Quality & Regulatory Engineer II in Basingstoke
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend virtual meetups, and engage on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that Quality & Regulatory Engineer role.
✨Tip Number 2
Prepare for that interview! Research the company and its compliance practices, and be ready to discuss how your experience aligns with their needs. We suggest practising common interview questions related to quality assurance and regulatory standards to boost your confidence.
✨Tip Number 3
Showcase your skills! Create a portfolio or a presentation that highlights your achievements in quality management and compliance. We love seeing candidates who can demonstrate their problem-solving abilities and technical writing skills in action.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re always on the lookout for passionate individuals who thrive in regulated environments, so make sure you get your name in the mix!
We think you need these skills to ace Quality & Regulatory Engineer II in Basingstoke
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights your experience in quality assurance and compliance. Use keywords from the job description to show that you’re a perfect fit for the Quality & Regulatory Engineer II role.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Share your passion for compliance and continuous improvement, and explain how your background aligns with the responsibilities of the position. Keep it concise but impactful!
Showcase Your Technical Skills:Don’t forget to mention your proficiency with electronic Quality Management Systems like MasterControl or TrackWise. Highlight any relevant projects or experiences that demonstrate your technical writing and problem-solving skills.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team!
How to prepare for a job interview at Randstad Engineering
✨Know Your Regulations
Make sure you brush up on GMP/GxP regulations and ISO standards relevant to the role. Being able to discuss these in detail will show your technical expertise and commitment to compliance.
✨Prepare for Problem-Solving Questions
Expect questions about how you've handled quality issues in the past. Have specific examples ready that highlight your root cause analysis skills and the corrective actions you implemented.
✨Familiarise Yourself with eQMS
Since proficiency with electronic Quality Management Systems is crucial, be prepared to discuss your experience with systems like MasterControl or TrackWise. If you have any specific achievements using these tools, share them!
✨Showcase Your Technical Writing Skills
As a Quality & Regulatory Engineer, strong documentation is key. Bring samples of your work or be ready to discuss how you've authored compliance logs and SOPs in previous roles.
