At a Glance
- Tasks: Guide quality management processes and ensure compliance with industry standards.
- Company: LGC Clinical Diagnostics, a leader in diagnostic quality solutions.
- Benefits: 25 days holiday, health allowance, discounts, and recognition schemes.
- Why this job: Make a real impact on patient outcomes through quality assurance.
- Qualifications: Bachelor’s degree in Science or Engineering and 3+ years in Quality Assurance.
- Other info: Join a diverse team committed to continuous improvement and innovation.
The predicted salary is between 36000 - 60000 £ per year.
LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, pharmaceutical, CRO and academic institutions in commercialisation activities across the entire diagnostic pipeline. Professionals in clinical chemistry, immunochemistry, serology, and molecular diagnostics rely on LGC's products for accurate diagnostic results. Our exceptional team, scientific expertise, efficient operations, and quality systems support a range of advanced technologies daily, improving patient outcomes.
Job Purpose
The Senior Quality Specialist position will advance LGC Clinical Diagnostics’ purpose of Science for a Safer World by supporting and contributing to TNAC’s product quality and Quality Management System processes. LGC Clinical Diagnostics’ TNAC Kidlington location is seeking a candidate who is experienced with a working knowledge of quality system requirements to ISO 9001. The successful candidate will have a strong orientation toward continuous improvement.
Key Responsibilities
- Provide direction and guidance to the TNAC team in execution of and compliance with the Quality Management System.
- Maintain excellent communication with manager and site leadership to ensure quality issues are raised and addressed.
- Provide and document Quality training of new employees.
- Accurate review and approval of records comparing results to internal and customer specifications, SOPs, and established standards for product release.
- Ensure accurate QMS records related to nonconformances, deviations, and CAPAs.
- Review and approval of protocols, reports, and change management documentation ensuring defendable practices and conclusions.
- Utilise quality tools to track and trend quality performance and identify key opportunities for improvement.
- Work with functional groups to investigate quality issues, determine root cause, and suggest and implement corrective and preventive actions.
- Perform product release activities such as review of labels, batch records, and QC results.
- Process and approve document change requests followed by providing notification of changes to controlled documents to relevant parties.
- Perform internal audits, issue audit reports, and follow up to close out actions which address the findings.
- Promote and contribute to continuous improvement activities.
- Host audits and regulatory inspections.
- Provide advice to other departments to ensure compliance with company policies, procedures, and best practices.
- Provide training on new and existing SOPs and major updates to SOPs and maintain training records.
- Perform other related duties as assigned by management.
Knowledge, Experience and Technical Skills
- Strong interpersonal, organizational, verbal and written communication skills.
- Demonstrates curiosity, integrity, brilliance, respect, and passion; works best in a team environment and actively seeks to foster relationships.
- Ability to ask probing questions to understand unstated expectations and underlying issues, understand competing priorities, and facilitate discussions to gain consensus through the problem-solving process.
- Oriented to continuous improvement.
Education and/or Experience
- Minimum of a Bachelor’s degree in a relevant Science, Engineering or QA discipline.
- 3+ years industry experience working in a Quality Assurance role in a regulated environment for medical devices, pharmaceutical, or biotechnology industry.
- Working knowledge of ISO 9001 or equivalent Quality Management System principles.
Our values
- PASSION
- CURIOSITY
- INTEGRITY
- BRILLIANCE
- RESPECT
Join us and enjoy:
- 25 days holidays
- Life assurance & health allowance
- Discounts with local and national retailers
- Free 24/7 Employee Assistance Programme
- Recognition schemes and monetary awards
At LGC, we foster a culture of inclusion and collaboration. We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply. We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities. If you require any adjustments throughout the recruitment process, please let us know. Join us in this outstanding opportunity to be part of a company that is leading advancements in the industry!
Senior Quality Specialist - 12 months contract in Kidlington employer: LGC Group
Contact Detail:
LGC Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Specialist - 12 months contract in Kidlington
✨Tip Number 1
Network like a pro! Reach out to current or former employees at LGC Clinical Diagnostics on LinkedIn. A friendly chat can give us insider info about the company culture and maybe even a referral!
✨Tip Number 2
Prepare for the interview by brushing up on ISO 9001 standards and quality management systems. We want to show that we’re not just familiar with the terms, but that we can apply them in real-world scenarios.
✨Tip Number 3
Practice our STAR technique (Situation, Task, Action, Result) for answering behavioural questions. This will help us articulate our experiences clearly and demonstrate how we’ve contributed to continuous improvement in past roles.
✨Tip Number 4
Don’t forget to follow up after the interview! A quick thank-you email reiterating our enthusiasm for the role can keep us fresh in their minds. Plus, it shows we’re genuinely interested in joining the team!
We think you need these skills to ace Senior Quality Specialist - 12 months contract in Kidlington
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Senior Quality Specialist role. Highlight your experience with ISO 9001 and any relevant quality management systems to show us you’re the right fit!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you’re passionate about quality assurance and how your background aligns with our mission of Science for a Safer World. Keep it engaging and personal!
Showcase Continuous Improvement Mindset: We love candidates who are all about continuous improvement! In your application, share specific examples of how you've contributed to quality enhancements in previous roles. This will really catch our eye!
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity. We can’t wait to hear from you!
How to prepare for a job interview at LGC Group
✨Know Your Quality Systems
Make sure you brush up on ISO 9001 and other quality management principles. Be ready to discuss how you've applied these in your previous roles, especially in regulated environments. This will show that you understand the core of what LGC Clinical Diagnostics is all about.
✨Show Your Continuous Improvement Mindset
Prepare examples of how you've contributed to continuous improvement in past positions. Whether it’s through implementing new processes or enhancing existing ones, demonstrating your proactive approach will resonate well with the interviewers.
✨Communicate Effectively
Since this role involves maintaining excellent communication with various teams, practice articulating your thoughts clearly. Think about how you can convey complex quality issues in a straightforward manner, as this will be crucial for the Senior Quality Specialist position.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific quality issues or audits. Prepare by thinking through potential scenarios related to nonconformances or CAPAs, and outline your thought process for resolving them. This will showcase your problem-solving skills and readiness for the role.