Mid-Senior level £27.00/hr - £32.00/hr United Kingdom Slough, England, United Kingdom
45 days ago
Associate Principal QA Specialist, QA Technical
Location: Slough (initially onsite with possibility of 1-2 days working from home thereafter)
Schedule: Standard Office Hours
Duration: 12-Month Contract
Pay: £27-32/hr
Job Responsibilities
In this role, you will support Quality Assurance (QA) compliance initiatives across site operations. Key responsibilities include:
• Overseeing the review, approval, and management of quality records, including deviations, CAPAs, change controls, and investigations.
• Collaborating with cross-functional teams to resolve compliance issues and promote continuous improvement.
• Providing subject matter expertise (SME) on GMP processes, maintaining audit readiness and regulatory compliance.
• Coaching teams to uphold and enhance a culture of quality.
Essential Duties and Job Functions
• Provide direct support and approval of quality documentation (e.g., Deviations, CAPAs, Change Controls, OOS).
• Manage critical compliance issues through site QMS processes, ensuring timely escalation and resolution.
• Actively identify and contribute to quality and process improvement initiatives.
• Serve as QA SME in governance forums and cross-functional project teams.
• Support manufacturing operations during regular and off-hours as needed.
• Maintain ongoing audit readiness in alignment with regulatory and internal standards.
• Participate in development and enhancement of quality systems and documentation.
• Coach and mentor operational staff on cGMP and quality best practices.
• Execute additional duties as assigned by QA leadership.
Knowledge & Skills
• Strong decision-making and problem-solving abilities.
• Solid understanding of GMP compliance and quality systems.
• Effective communication and interpersonal skills to influence and guide stakeholders.
• Strong attention to detail and organizational skills.
• Continuous improvement mindset with experience in quality/process optimization.
• Ability to manage multiple priorities and meet tight deadlines.
• Comfortable working in cross-functional teams and high-paced environments.
Education & Experience
• Education: Bachelor's degree in a scientific discipline (required).
• Experience: Advanced-level experience in QA or QC.
• Prior experience reviewing and approving GMP documentation (e.g., deviations, CAPAs, change controls, OOS) is essential.
• Familiarity with pharmaceutical/biotech regulatory requirements preferred.
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