QA Specialist (FTC) in Cambridge

bit.bio Cambridge, England, United Kingdom

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bit.bio is an award-winning spinout from the University of Cambridge. Our breakthrough technology combines synthetic and stem cell biology for the precise, efficient and consistent reprogramming of human cells used in research, drug discovery, and cell therapy. At bit.bio, we are passionate about engineering human cells that will enable the medicine of the future. To do this we need talented and curious people who want to make an impact on the future of science and therapeutics.

As a team of individuals, we value science, collaboration, openness, curiosity and creativity. We are united by trust and respect for each other.

Location: Babraham Research Park, Cambridge>

Type: Full time, 12 months fixed term contract (maternity cover)

Salary: Competitive / Hours: 40 p/w

Cambridge Based Position – hybrid working available

This Fixed Term Contract (FTC) is to cover a period of maternity leave for up to 12 months, or on return of the substantive postholder, whichever is earlier.

Your role in our team:

We\’re looking for a QA professional with experience in regulated industries such as pharmaceuticals or biotech, someone who is eager to bring that discipline into a dynamic, non-GMP, research product use only setting. Reporting to the Director of Quality & Compliance, you will be the QA Specialist driving supplier qualification, elevating cross-site QMS harmonisation, strengthening change-control excellence and crafting high-impact policies and SOPs. You\’ll also play a key role in guiding our eQMS evaluation and implementation. In this autonomous position, you\’ll thrive in a fast-paced environment, managing a high volume of document updates, change controls, and audit activities with confidence and precision. Your calm, solutions-focused approach will shine as you triage last-minute queries and help keep the organisation ISO 9001 ready.

Key Responsibilities

• Supplier qualification and audits – End-to-end supplier qualification from pre-audit evidence and agenda design to on-site reviews, document sampling and objective evidence capture.
• Clear, actionable audit reporting including concise graded reports, CAPA tracking to closure and risk-based supplier classification with an up-to-date risk register.
• Plan and run distributor and ISO 9001 audits, complete follow-ups and craft practical QTAs covering training, change control, CAPA, audit rights, storage/transport, and data integrity.
• Change control and impact assessment enablement
• Guide teams to create high-quality change controls backed by best-practice records and traceable documentation.
• Streamline and manage change activity and handle high-volume edit spikes with ease.
• Documentation & eQMS (Document Control, Events, Training) – Develop key Quality policies/SOPs/WIs (Data Integrity, Document Control, Validation/Qualification, Stability).
• Manage eQMS document routing: track cycle times, maintain SLA compliance, and drive reviews to approval.
• Support eQMS implementation and rollout.
• Product & Process Quality Oversight – Review key QC records and deviations/CAPAs.
• Support validation/qualification activities.
• Assist with quality event investigations to define corrective actions and assess broader impact.
• Stakeholder Engagement – Partner with multiple bit.bio functions to provide QA SME support and engage external suppliers\’ QA.
• Communicate critical release information clearly to all relevant and impacted stakeholders.
• Audits & Inspection Readiness
• Maintain and promote a state of customer audit/regulatory inspection readiness.
• Reporting, Training & Communication – Deliver monthly QA KPIs with insights and actions, plus targeted briefings to drive first-time-right performance.

Qualifications

• Hold a minimum Bachelor\’s degree qualification (or equivalent experience) in a relevant scientific or engineering discipline.
• Have demonstrable experience in a Quality Assurance focused role within a regulated environment (pharmaceutical, medical device, biotech or equivalent).
• Proven supplier auditing experience (planning, on-site execution, reporting CAPA follow-up) and QTA authorship/negotiation.
• Practical knowledge and understanding of ISO 9001.
• Hands‑on eQMS proficiency (e.g., Veeva/Dot Compliance or equivalent) across document control, training, and quality events; policy/SOP authorship with risk-tiered validation logic and practical decision trees.
• Change-control governance and coaching excellence; able to create job aids and manage high-volume edits.
• Resilient under adoc, able to triage last-minute requests while maintaining right-first-time quality.
• Validation/qualification exposure (IQ/OQ/PQ; VMP authorship/support) – optional.
• Familiarity with NetSuite (labels/numbering) and data-integrity by design – optional.
• Distributor audit experience advantageous – optional.

Benefits

bit.bio provides a vibrant and dynamic work environment in an exciting, fast-moving time for biology. We work with cutting edge technologies and with our world-leading scientific advisory board. We conduct pioneering work with real-world impact. We trust our people to make significant contributions early on with opportunities to be involved in projects that are key to the success and growth of our young company. We invest in people, creating opportunities for personal development in an inclusive multi-skilled team with ambitious goals that provide opportunities to learn on the job from each other. Creativity and open minds are encouraged for everyone to contribute to the success of the company.

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