Touchlight is currently seeking an experienced QC analyst to join the QC Team as part of the Touchlight DNA Services CDMO company.The Quality Control Analyst is responsible for the supporting the Quality Control (QC) laboratory for raw material assessment and approval and day-to-day QC analysis to help support the production of dbDNA as a critical starting material for ATMP production and as an Active Pharmaceutical Ingredient.
You will be an experienced QC professional with the ability to lead raw material sampling and testing strategies following appropriate GMP and GLP. The QC Analyst reports to the QC Manager in support of an operational QC function. There will be close working with the QA, Compliance, CMC-Development, Production, Continuous Improvement and Business Development Teams to support on-going project and product needs This is an exciting, fast-paced environment suited to self-motivated, organised, conscientious, and highly accurate individuals, who can contribute to and successfully work in a multi-talented and compliance orientated team.
- Lead activities for raw materials management, including QC sampling and testing regime.
- Conduct IPC and finished product analysis routinely for under GMP compliance.
- Coordinate and organise QC support activities, including reagent preparations, goods receipt, sample receipt, procurement, and good housekeeping activities.
- Support the QC Responsible Person in equipment and instrument calibrations.
- Apply data integrity principles throughout all QC activities.
- Support the QC function with Quality Events and Laboratory Investigations.
- Deliver QC training initiatives, where necessary.
- Identify opportunities for improvement and implement those continuous improvement initiatives.
- A holistic approach to QC and how this operates in a CDMO company.
- Work closely with colleagues in the QA, Compliance, Regulatory, Operations and Development departments
- Experience in Good Documentation Practices
- Experience in participating in client and regulatory audits is desirable.
- Experience in internal auditing is desirable.
- Strong IT, multitasking and communication skills.
- Confidence to challenge and simplify existing systems & processes.
- A self-starter, with a desire to meet targets and drive success.
- Innovative, pragmatic, team-focused and customer-oriented in personality.
- BA/BSc or equivalent educational background.
- Strong experience of working within a GMP and/or GLP environment.
- A minimum of 2 years’ experience working in a QC function role.
- Requirement to have worked for a CDMO at all stages of product development.
- A proven ability to implement, lead and coordinate QC sampling and testing strategies in the QC function.
- Experience of reagent preparations and material handling, including aseptic techniques.
- A high attention to accuracy and precision
- A strong knowledge of GMP and GLP laboratory systems
Applicants MUST be eligible to work in the UK.
Apply for this role by emailing a CV and cover letter to email@example.com clearly stating the reference "QC Analyst”
Due to the high number of applicants, we will only contact those who we invite to interview.