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- Tasks: Support operations in ensuring compliance with GMP and manage quality records.
- Company: Join a leading global biopharmaceutical company dedicated to quality and innovation.
- Benefits: Competitive pay, potential for hybrid work after training, and opportunities for continuous improvement.
- Why this job: Be part of a dynamic team driving quality standards and making a real impact in healthcare.
- Qualifications: Advanced degree in a scientific field with 5-10 years of QA experience required.
- Other info: Onsite role in Slough with a focus on mentorship and professional growth.
The predicted salary is between 60000 - 84000 £ per year.
Contract: 12 months
Location: Slough (onsite) – potential for hybrid after training complete
Salary: £31.99 PAYE, £40.47 Umbrella per hour (Inside IR35)
Hours: 37.5 hours per week
Reports to: QA Manager (QA Technical Support)
Role Purpose & Scope:
- Support Operations to ensure Compliance to GMP
- Manage and support GMP issues through QMS processes, site governance and senior QA leadership.
- Act as a GMP SME by implementing, managing and enforcing quality processes on site.
- Support Senior QA leadership to drive continuous improvement and ‘fitness for purpose’.
- Maintain compliance with Regulatory Authorities requirements, Global Quality standards and our clients Customer expectations.
Key Responsibilities:
- Provide shoulder to shoulder review, approval and support to key business partners for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations, OOS.
- 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 and quality culture.
- Maintain and promote a state of audit readiness.
- Actively suggest, initiate, participate and contribute to PQS process improvement initiatives and projects.
- Provide QA SME support at departmental Local Quality Councils and project meetings.
- Provide QA SME Support for manufacturing during out of hours.
- Perform other duties as assigned.
Key Metrics:
- KPI Targets (in addition to abiding relevant quality systems standards (ISO 9001, ISO 13485) & where relevant complying to applicable pharmaceutical GMP standards (US and European) / 21CFR820 as well as abiding & role modelling for all Health, Safety and Environmental rules and guidelines)
- Deviation assessment completed within 2 days
- Zero overdue quality records
Key Stakeholders:
- Manufacturing Operations (Cell Banking, Fermentation, Purification and Manufacturing Support)
- Warehouse and Supply Chain
Required Skills & Competencies:
- Excellent decision-making and problem solving skills.
- Strong Quality mindset.
- Strong business and interpersonal skills and be a persuasive communicator in written, oral and active listening to influence peers and colleagues.
- Strong Continuous Improvement mindset.
- Excellent communication skills (verbal and written).
- Ability to meet strict deadlines.
- Excellent organizational and planning skills.
Qualifications (Min. requirements to perform assigned tasks):
- Education/Degree Field of Study - Scientific
- Language(s) Required: English 2 - Business Fluent
- Work Experience Area: Quality (QA or QC)
- Level: Advanced - 5-10 years
Associate Principal QA Specialist employer: SRG
Contact Detail:
SRG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Principal QA Specialist
✨Tip Number 1
Familiarise yourself with GMP regulations and quality management systems. Understanding the specific compliance requirements in the biopharmaceutical industry will help you demonstrate your expertise during interviews.
✨Tip Number 2
Network with professionals in the QA field, especially those who work in biopharmaceuticals. Engaging with industry peers can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with CAPA, deviations, and change controls in detail. Be ready to share specific examples of how you've managed these processes effectively in previous roles.
✨Tip Number 4
Showcase your continuous improvement mindset by thinking of innovative solutions to common QA challenges. Being able to articulate your ideas on enhancing quality processes will set you apart from other candidates.
We think you need these skills to ace Associate Principal QA Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Assurance, particularly in GMP compliance and quality processes. Use specific examples that demonstrate your decision-making and problem-solving skills.
Craft a Strong Cover Letter: Write a cover letter that clearly outlines your motivation for applying to the Associate Principal QA Specialist role. Mention how your background aligns with the key responsibilities and required skills listed in the job description.
Highlight Continuous Improvement Experience: In your application, emphasise any previous roles where you actively participated in continuous improvement initiatives. Provide concrete examples of how you contributed to enhancing quality processes or compliance.
Showcase Communication Skills: Since strong communication skills are essential for this role, ensure your application reflects your ability to communicate effectively. Use clear and concise language, and consider including examples of how you've influenced peers or stakeholders in past positions.
How to prepare for a job interview at SRG
✨Showcase Your GMP Knowledge
Make sure to highlight your understanding of Good Manufacturing Practices (GMP) during the interview. Be prepared to discuss specific examples of how you've implemented or enforced quality processes in previous roles.
✨Demonstrate Problem-Solving Skills
Prepare to share instances where you've successfully resolved compliance issues or improved quality processes. This will showcase your decision-making abilities and your proactive approach to quality management.
✨Communicate Effectively
Since strong communication skills are essential for this role, practice articulating your thoughts clearly and concisely. Be ready to explain complex concepts in a way that is easy to understand, as you may need to influence peers and stakeholders.
✨Emphasise Continuous Improvement
Be ready to discuss your experience with continuous improvement initiatives. Share specific examples of how you've contributed to enhancing quality systems or processes, demonstrating your commitment to maintaining a high standard of quality.
