QA Specialist with GMP

TN United Kingdom; Stevenage; On-site; GBP 45,000 - 50,000; Full time

Job summary

An established industry player is seeking a QA Specialist to join their team on a 12-month fixed-term contract. This role is crucial for ensuring compliance with regulatory standards and supporting the expansion of a manufacturing facility. The ideal candidate will bring 5 to 10 years of experience in a clinical environment, particularly in biologics or ATMPs. You will work closely with multidisciplinary teams, manage regulatory inspections, and promote a quality-focused culture. This is a fantastic opportunity to contribute to innovative projects in a dynamic setting.

Qualifications

• 5-10 years of experience in a clinical environment.
• Experience as a Quality Specialist in biologics.

Responsibilities

• Oversee activities related to facility expansion.
• Serve as main contact for Quality interactions.

Skills

Regulatory Compliance

Quality Assurance

Communication Skills

Project Management

Attention to Detail

Education

Degree in Life Sciences

Job description

QA Specialist - Project Support – 12 month Fixed Term Contract

Our client is seeking a QA Specialist with 5 to 10 years of experience in a clinical environment.

Reporting to the Head of Quality Assurance, this role will ensure that the manufacturing centre, through proactive engagement, meets the standards of regulatory authorities and potential collaborators.

Responsibilities:

1. Work within a multidisciplinary team to oversee activities related to the facility expansion.
2. Serve as the main point of contact for all Quality interactions between the manufacturing centre and third-party contractors.
3. Assist in preparing for and managing regulatory agency and client inspections related to the expansion.
4. Maintain the PQS in a compliant state for a multi-purpose, multi-client facility, ensuring consistency with existing processes.
5. Provide quality expertise to the expansion project team.
6. Support compliance by advising and escalating issues appropriately.
7. Promote awareness of quality requirements and support a quality-focused culture.

Experience and Skills:

• Experience in multidisciplinary project teams, facility and/or cleanroom qualification, and sterile manufacturing processes, ideally ATMPs or biologics.
• Knowledge of EMA and FDA regulatory requirements.
• Familiarity with global standards like ISO 9001.
• Experience as a Quality Specialist in biologics, preferably cellular and/or gene therapies.
• Ability to manage multiple tasks with attention to detail.
• Autonomous work style with goal orientation.
• Excellent communication skills.
• Pragmatic GMP advice and current professional knowledge.
• Ability to build rapport across departments.
• Strong organizational skills and team spirit.

Education: Degree in life sciences. Membership in professional organizations (e.g., RSC, SOB, CQI) is desirable.

Location: Stevenage, Hertfordshire.

Salary: £45K - £50K.

Please send your CV in Word format, including your salary expectations and availability.