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- Tasks: Oversee Quality Assurance activities and manage GMP issues in a biotech environment.
- Company: Join a leading biotech company committed to quality and compliance.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative culture with mentorship opportunities and career advancement.
- Why this job: Make a real impact on quality assurance in a dynamic biotech setting.
- Qualifications: Experience in QA, GMP knowledge, and strong communication skills.
The predicted salary is between 50000 - 65000 £ per year.
Enable site operations performance by managing and supporting GMP issues through QMS processes, site governance and senior QA Leadership. Provide oversight on day to day Quality Assurance activities in the areas of Validation / Technical Services in accordance with Lonza Corporate requirements, standards and current regulatory requirements, meeting USFDA, European requirements and others as applicable for a multi-product, GMP biotech contract manufacturing facility.
To provide shoulder to shoulder review, approval and support for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations.
Primary Responsibilities- Provide oversight over day to day Quality assurance activities in the areas of Technical Services and Validation in accordance with Lonza Corporate requirements, standards and current regulatory requirements.
- Utilize knowledge of GMP and quality processes within the functional areas to manage and escalate Major and Critical compliance issues through the site QMS processes e.g. deviations and CAPAs.
- Actively identify, suggest and participate in continuous improvement activities.
- Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment.
- Maintain and promote a state of audit readiness.
- Actively suggest, initiate, participate and contribute to PQS process improvements initiatives and projects.
- Provide QA SME support at departmental Local Quality Councils and project meetings.
- Provide shoulder to shoulder review, approval and QA Technical support to key business partners for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations.
- Provide coaching and training to other team members.
- Provide QA project support to complex projects.
- Performs other duties as assigned.
Associate Principal QA Specialist (CQV) employer: LanceSoft Inc
Contact Detail:
LanceSoft Inc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Principal QA Specialist (CQV)
✨Tip Number 1
Network like a pro! Reach out to current employees at Lonza or in similar roles on LinkedIn. A friendly chat can give you insider info and might even lead to a referral.
✨Tip Number 2
Prepare for the interview by brushing up on your GMP knowledge and quality assurance processes. We want you to showcase your expertise, so think of examples where you've tackled compliance issues or led improvement initiatives.
✨Tip Number 3
Don’t just wait for job postings! Keep an eye on our website and apply directly. Sometimes, the best opportunities come from being proactive and showing your enthusiasm for the role.
✨Tip Number 4
Follow up after your interview with a thank-you note. It’s a simple gesture that shows your appreciation and keeps you fresh in their minds. Plus, it’s a great chance to reiterate your interest in the position!
We think you need these skills to ace Associate Principal QA Specialist (CQV)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that align with the Associate Principal QA Specialist role. Highlight your knowledge of GMP processes and any relevant QA activities you've been involved in.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're passionate about quality assurance and how your background makes you a great fit for our team. Don’t forget to mention specific examples of your experience with CAPAs and deviations!
Showcase Continuous Improvement Mindset: We love candidates who are proactive about improvement! Share any initiatives you've led or participated in that enhanced quality processes or compliance in your previous roles.
Apply Through Our Website: For the best chance of success, make sure to apply directly through our website. This way, we can easily track your application and get back to you quicker!
How to prepare for a job interview at LanceSoft Inc
✨Know Your GMP Inside Out
Make sure you brush up on your Good Manufacturing Practice (GMP) knowledge. Understand the key regulations and standards that apply to the role, especially those from USFDA and European authorities. Being able to discuss these confidently will show that you're serious about quality assurance.
✨Prepare for Scenario Questions
Expect to be asked about how you've handled compliance issues in the past. Think of specific examples where you managed deviations or CAPAs. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly and effectively.
✨Show Your Continuous Improvement Mindset
Be ready to discuss how you've contributed to process improvements in previous roles. Highlight any initiatives you've led or participated in that enhanced quality assurance practices. This will demonstrate your proactive approach and commitment to excellence.
✨Emphasise Team Collaboration
Since mentoring and coaching are part of the role, be prepared to talk about your experience working with cross-functional teams. Share examples of how you've supported colleagues in maintaining cGMP environments and how you foster a culture of quality within teams.