Quality Assurance Officer I

2 days ago

Dalkeith, United Kingdom RoslinCT Full time

**Quality Assurance Officer I**

**Location**: Shawfair

**Who are we?**

We are RoslinCT, a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives.

Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science.

Find out more about what we do here

**Why join us?**
- The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
- A generous salary package - we reward our people at the level they deserve.
- 31 days of annual leave, plus 4 public holidays which increases with tenure.
- A competitive company pension scheme to help you save for the future.
- Group Life Cover - you are automatically covered for three times your basic salary to give you and your family peace of mind.
- Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
- Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

**Your new role**
- An exciting opportunity for a Quality Assurance Officer to join our Quality team.
- You’ll be responsible for:

- Management and approval of artwork.
- Conducting internal audits to verify GMP compliance and identify areas for improvement.
- Assisting QA management with customer audits and regulatory inspections.
- Writing, reviewing and updating Standard Operating Procedures (SOPs) to ensure ensure alignment with company policies, current practices, and applicable regulatory standards and guidelines.
- Managing Supplier complaints, Quality Agreements and supporting audits of critical suppliers when necessary.
- Delivering training on quality related topics to employees across RoslinCT.
- Compiling quality metrics to facilitate monitoring of the RoslinCT Quality Management System (QMS).
- Review and approval of quality documentation, including Deviations, Change Controls and Risk Assessments.
- Reviewing data to verify GMP compliance and identify areas for improvement.

**About you**
- Experience in a similar role within a relevant industry (e.g. pharmaceutical industry / stem cell activities).
- Previous experience in a GMP environment.
- A clear understanding of GMP, regulatory and accreditation systems and quality management.
- Proven experience in the maintenance of an electronic Quality Management System.
- Have excellent influencing, communication, interpersonal and, motivational skills.
- An ability to take decisions, to analyse information in a logical manner and to prepare coherent investigative and/or technical reports.
- Competent in computer packages including Microsoft Office and an electronic quality management package.
- Excellent administration and record keeping skills.

**Qualifications**
- Educated to degree level in a Life Sciences discipline.

**Next Steps**
- At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners._

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