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QA Operations Specialist

JR United Kingdom

London

On-site

GBP 35,000 - 55,000

Full time

9 days ago

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Join a pioneering biopharmaceutical organization as a QA Operations Specialist, where you'll ensure compliance with GMP standards in the production of life-changing therapies. This role offers a unique opportunity to work in a fast-paced ATMP environment, supporting critical manufacturing operations. You'll be involved in quality oversight, batch review, and regulatory submissions, making a tangible impact on patient lives. With a competitive salary and benefits, along with a collaborative team culture, this position is perfect for those looking to advance their QA career in a cutting-edge field.

Competitive Salary

Career Growth Opportunities

Collaborative Team Culture

Experience in GMP quality assurance in pharmaceuticals or biotechnology.
Strong understanding of GMP, GDP, and regulatory guidelines.

Provide quality oversight of GMP manufacturing activities.
Support batch review and release processes.

GMP Quality Assurance

Attention to Detail

Problem-Solving

Communication Skills

Collaboration Skills

Quality Systems

Deviation Management

CAPA Management

Change Control

QA Operations Specialist – London – Competitive Package

BioTalent are happy to be supporting an ATMP organisation looking to recruit a QA Ops Specialist. In this role, you will play a critical part in ensuring GMP compliance in manufacturing operations, supporting the production of life-changing cell and gene therapies.

This role is working a Wednesday-Saturday or Sunday-Wednesday shift (Offers 13% shift allowance)

Key Responsibilities:

Provide quality oversight of GMP manufacturing activities to ensure compliance with regulatory requirements.
Support batch review and release processes, including documentation review and deviation assessments.
Participate in investigations of deviations, CAPAs, and change controls, ensuring timely resolution and continuous improvement.
Conduct GMP audits and inspections of manufacturing areas, ensuring adherence to SOPs and quality standards.
Review and approve manufacturing and laboratory records, including equipment qualification and validation protocols.
Act as a key QA liaison between production, QC, and regulatory teams to maintain high-quality standards.
Support regulatory submissions and inspections (MHRA, FDA, EMA), ensuring readiness and compliance.
Provide training and mentoring to manufacturing teams on quality and compliance best practices.

Requirements:

Experience in GMP quality assurance within a pharmaceutical or biotechnology environment, preferably in ATMP, cell therapy, gene therapy, or biologics.
Strong understanding of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and relevant regulatory guidelines (MHRA, EMA, FDA, ICH, Eudralex).
Experience with quality systems such as deviations, CAPAs, change control, and batch record review.
Excellent attention to detail, problem-solving skills, and ability to work in a fast-paced environment.
Strong communication and collaboration skills, with experience working cross-functionally.

What’s in it for you?

Be part of a cutting-edge biopharmaceutical company making a real impact on patients' lives.
Work in an innovative and fast-growing ATMP environment.
Competitive salary and benefits package, including career growth opportunities.
A supportive and collaborative team culture.

Apply now and take the next step in your QA career with an exciting ATMP company!

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