Associate Principal QA Specialist

JR United Kingdom; Reading; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading company in the biopharmaceutical sector is seeking a Principal QA Specialist for a 12-month contract in Slough, with potential for hybrid working after training. The role focuses on ensuring GMP compliance, managing quality records, and supporting continuous improvement initiatives. Ideal candidates will possess strong problem-solving and decision-making skills alongside a commitment to quality assurance practices.

Qualifications

• Strong decision-making and problem-solving skills.
• Excellent communication and organizational skills.
• Quality mindset requirement.

Responsibilities

• Support management of quality records and compliance issues.
• Mentor staff in cGMP practices.
• Ensure audit readiness and support PQS process improvements.

Skills

Decision-making

Problem-solving

Quality mindset

Communication

Organizational skills

Job description

Job Title: Principal QA Specialist – Global Biopharmaceutical

Contract: 12 months

Location: Slough (onsite) – potential for hybrid after training complete

Hours: 37.5 hours per week

Reports to: QA Manager (QA Technical Support)

Position: Associate Principal QA Specialist, QA Technical Operations

Primary Location: Slough

Role Purpose & Scope

This role exists to support Operations in ensuring GMP compliance, manage GMP issues through QMS processes, act as a GMP SME, and support continuous improvement initiatives to maintain regulatory and client standards.

Key Responsibilities

1. Review and support management of quality records such as Deviations, CAPA, Change Controls, Investigations, and OOS.
2. Manage and escalate compliance issues via site QMS, utilizing GMP knowledge.
3. Identify and participate in continuous improvement activities.
4. Mentor staff in cGMP practices to foster a quality culture.
5. Ensure audit readiness.
6. Support PQS process improvements and projects.
7. Provide QA SME support in departmental councils and during manufacturing out-of-hours.
8. Perform other duties as assigned.

Key Metrics

Deviation assessments completed within 2 days, adhering to relevant standards and safety guidelines.

Key Stakeholders

• Manufacturing Operations (Cell Banking, Fermentation, etc.)
• Warehouse and Supply Chain

Qualifications

Minimum requirements include strong decision-making, problem-solving skills, a quality mindset, excellent communication, and organizational skills.