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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