Associate Principal Specialist, Technical

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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