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- Tasks: Support GMP compliance and quality assurance in a dynamic manufacturing environment.
- Company: Join a leading company in the pharmaceutical industry focused on quality and innovation.
- Benefits: Enjoy a 9-month role with potential extension, onsite experience, and opportunities for professional growth.
- Why this job: Be part of a team driving continuous improvement and ensuring high-quality standards in production.
- Qualifications: Bachelor's degree in Biology or related field; strong IT and communication skills required.
- Other info: This role offers hands-on experience in quality assurance and regulatory compliance.
The predicted salary is between 36000 - 60000 £ per year.
Location: Slough, Berkshire SL1 4DX
Duration: 9-month role with potential to extend
Fully onsite position
Role Purpose & Scope:
Enable site operations performance by managing and supporting GMP issues through QMS processes, site governance and senior QA leadership. Ensure that quality is maintained at an appropriate level meeting customer and regulatory expectations and enable the Slough Site to deliver to relevant targets. This will be achieved by assessing compliance with site PQS and principles of GMP auditing documentation generated during manufacturing processes, development and laboratory processes and where required escalating non-compliance through the PQS, site governance mechanisms and senior QA Leadership. Supporting Senior QA leadership to drive continuous improvement. Maintaining compliance with Regulatory Authorities requirements, Global Quality standards and client’s Customer expectations.
Key Responsibilities:
- To provide shoulder to shoulder review of documentation generated during manufacturing processes, development and laboratory processes.
- Advise areas of support on best practice for document completion, review and follow up actions/ escalate if required.
- Acting as a point of contact for general queries relating to Quality and escalating as required.
- Expand and utilize knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel.
- 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.
- To actively identify, suggest and participate in continuous improvement activities.
- Mentor and coach business partners in cGMP practice to maintain and develop a cGMP environment.
- Maintain and promote a state of audit readiness.
- Actively suggest, initiate, participate and contribute to PQS process improvement initiatives and projects.
Key Stakeholders:
- Manufacturing
- Material Science and Technology (MSAT)
- Supply Chain
Required Skills & Competencies:
- IT literate (MS Office – Word, Explorer, Excel, Access, Outlook) familiarity with database entries
- Verbal and written communication skills
- Risk based decision making
- PQS experience
- Accurate data entry skills, high attention to detail
- Demonstrated workload prioritization skills, decision making and scheduling skills
- Ability to meet strict deadlines
- Good organizational and planning skills.
Education/Degree Required:
Bachelors of Science (or equivalent experience) Field of Study Biology or related field
GMP Quality Assurance Associate employer: LanceSoft UK
Contact Detail:
LanceSoft UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land GMP Quality Assurance Associate
✨Tip Number 1
Familiarise yourself with GMP guidelines and quality assurance processes. Understanding the specific regulations and standards that govern the industry will not only help you in interviews but also demonstrate your commitment to maintaining high-quality standards.
✨Tip Number 2
Network with professionals in the pharmaceutical and biotechnology sectors. Attend industry events or join relevant online forums to connect with people who can provide insights into the role and potentially refer you to opportunities at StudySmarter.
✨Tip Number 3
Prepare to discuss specific examples of how you've handled compliance issues or contributed to quality improvement initiatives in previous roles. This will showcase your practical experience and problem-solving skills, which are crucial for the QA Associate position.
✨Tip Number 4
Stay updated on the latest trends and technologies in quality assurance and GMP practices. Being knowledgeable about current developments will help you stand out as a candidate who is proactive and engaged in the field.
We think you need these skills to ace GMP Quality Assurance Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in GMP and quality assurance. Emphasise any specific roles or projects where you managed compliance, documentation, or continuous improvement initiatives.
Craft a Strong Cover Letter: In your cover letter, explain why you're interested in the GMP Quality Assurance Associate role. Mention your understanding of the key responsibilities and how your skills align with the requirements, particularly in areas like risk-based decision making and document review.
Showcase Relevant Skills: Clearly outline your IT literacy, especially with MS Office and any database management experience. Highlight your attention to detail and ability to meet strict deadlines, as these are crucial for the role.
Prepare for Potential Questions: Think about how you would respond to questions regarding your experience with PQS processes and GMP practices. Be ready to discuss examples of how you've contributed to continuous improvement or resolved compliance issues in previous roles.
How to prepare for a job interview at LanceSoft UK
✨Know Your GMP Basics
Make sure you have a solid understanding of Good Manufacturing Practices (GMP) and how they apply to quality assurance. Brush up on relevant regulations and standards, as this will show your commitment to maintaining compliance and quality.
✨Prepare for Scenario Questions
Expect questions that ask you to describe how you would handle specific GMP-related scenarios. Think about past experiences where you identified non-conformances or contributed to continuous improvement initiatives, and be ready to discuss them in detail.
✨Showcase Your Attention to Detail
As a QA Associate, attention to detail is crucial. Be prepared to discuss how you ensure accuracy in documentation and data entry. You might even want to bring examples of your work that demonstrate your meticulousness.
✨Engage with Stakeholders
Since the role involves interaction with various stakeholders, think about how you would communicate effectively with different teams. Prepare to discuss your interpersonal skills and how you would mentor others in cGMP practices.
