At a Glance
- Tasks: Ensure compliance with quality standards and support audit readiness in a dynamic lab environment.
- Company: Join ACM Global Laboratories, a leader in biotechnology and pharmaceutical research.
- Benefits: Full-time role with competitive salary and opportunities for professional growth.
- Why this job: Make a real impact on quality assurance in a cutting-edge laboratory setting.
- Qualifications: Bachelor’s degree and experience in a lab or clinical research environment required.
- Other info: Collaborative culture with a focus on continuous improvement and career development.
The predicted salary is between 36000 - 60000 £ per year.
Schedule: Monday – Friday 9:00 AM – 5:00 PM
SUMMARY
As a Quality Assurance Auditor within the Quality team, the Quality Assurance Auditor promotes and supports a culture of audit readiness within ACM Global Laboratories. Responsible for overseeing regulated GCP & GLP activities including the development, implementation and on-going continuous improvement of the site’s Audit Program. In addition, the Quality Assurance Auditor will interface with the business and functional leaders of the regulated operational areas to promote and support compliance. This position also supports the generation and reporting of Key Quality Performance Indicators for the company’s Quality Systems.
RESPONSIBILITIES
- Serve as a resource for the promotion and compliance with regulations, guidelines, Quality Management System and Standard Operating Procedures within the organization, including training opportunities to staff at an organizational level
- Maintain current awareness of all required standards, laws and guidelines
- Support client, regulatory and sub-contractor audits
- Host/ Lead customer initiated audits and mock regulatory inspections and regulatory facility inspections
- Support Sr. QA Auditors, QA Supervisor and QA Manager, as needed
- Responsible for ensuring assigned internal audit & vendor audits are completed as scheduled and reporting associated metrics to Quality Assurance Management
- Participate in monthly laboratory Quality Assurance meetings, assisting the Manager, Quality Assurance, as needed
- Prepare for, carryout, report and follow up of Quality Assurance required audits, including internal, 3rd party and vendor audits
- Serve as Quality Assurance contact for assigned customers & functional areas
- Serve as subject matter expert in assigned area
- Manage the compliance and management of programs such as: Internal & External Audits, Vendor Management
- Identify process improvements and initiatives to improve efficiency and effectiveness of assigned program(s)
- Recognize problems related to project objectives and apply sound judgement when addressing the issues
- Review records created under the Quality System, to ensure compliance with defined processes
- Audit documents for compliance with regulations and QMS
- Monitor the compliance of all departments via routine audits to ensure adherence with internal Standard Operating Procedures & external regulations
- Recommend systems for audit, write audit plans, coordinate scheduling & closure of internal audits
- Manage and support client audits pre and post activities
- Perform other duties as assigned
REQUIRED QUALIFICATIONS
- Bachelor’s Degree & 1 Year experience in a laboratory, pharmaceutical, medical device or clinical research organization OR
- 4+ Years’ experience in a laboratory, pharmaceutical, medical device or clinical research organization
PREFERRED QUALIFICATIONS
- Effective written and oral communication, technical writing and editing skills
- Knowledge of and demonstrated experience in Quality Assurance, GCP, ISO15189, Proficiency Testing, CAP, CLIA, GLP
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Quality Assurance Auditor employer: ACM Global Laboratories
Contact Detail:
ACM Global Laboratories Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Auditor
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those already working at ACM Global Laboratories. A friendly chat can give us insights and maybe even a foot in the door.
✨Tip Number 2
Prepare for interviews by brushing up on GCP and GLP regulations. We want to show that we’re not just familiar with the standards but can also discuss how we’ve applied them in real situations.
✨Tip Number 3
Don’t forget to showcase our problem-solving skills! Think of examples where we identified issues and implemented improvements in previous roles. This will highlight our proactive approach.
✨Tip Number 4
Apply through our website! It’s the best way to ensure our application gets noticed. Plus, we can tailor our submission to align perfectly with what ACM Global Laboratories is looking for.
We think you need these skills to ace Quality Assurance Auditor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Quality Assurance Auditor role. Highlight your relevant experience in GCP, GLP, and any auditing you've done. We want to see how your background fits with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to our culture of audit readiness. Keep it engaging and personal – we love to see your personality!
Showcase Your Skills: In your application, don’t forget to showcase your effective communication and technical writing skills. These are key for the role, so give us examples of how you've used these skills in past experiences.
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at ACM Global Laboratories
✨Know Your Regulations
Familiarise yourself with the key regulations and guidelines relevant to the Quality Assurance Auditor role, such as GCP and GLP. Being able to discuss these confidently will show that you’re not just a candidate, but a knowledgeable resource.
✨Showcase Your Experience
Prepare specific examples from your past experience that demonstrate your auditing skills and compliance knowledge. Highlight any direct involvement in audits or quality management systems, as this will resonate well with the interviewers.
✨Ask Insightful Questions
Come prepared with questions that show your interest in the company’s audit culture and quality systems. Inquire about their current challenges in compliance or how they measure success in their audit programmes.
✨Demonstrate Continuous Improvement Mindset
Be ready to discuss how you’ve identified process improvements in previous roles. This aligns perfectly with the responsibilities of the position and shows that you’re proactive about enhancing efficiency and effectiveness.