Mid-Senior level £27.00/hr - £32.00/hr United Kingdom Slough, England, United Kingdom45 days agoAssociate 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 and 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 and 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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