Quality Assurance Officer I

RoslinCT; Dalkeith; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading cell and gene therapy organization in Scotland is seeking a Quality Assurance Officer to manage compliance with GMP standards. The ideal candidate will have experience in the pharmaceutical industry and strong communication skills. Join a company that values inclusivity and offers a generous benefits package, including a competitive salary. Opportunities for professional growth are available in a collaborative environment.

Benefits

31 days of annual leave plus 4 public holidays

Competitive salary package

Generous pension scheme

Private healthcare

Flexible benefits

Qualifications

• Experience in a relevant industry such as pharmaceuticals or stem cell activities.
• Understanding of GMP, regulatory, and accreditation systems.
• Ability to prepare coherent technical reports.

Responsibilities

• Manage and approve artwork.
• Conduct internal audits for GMP compliance.
• Assist with customer audits and regulatory inspections.
• Write and update Standard Operating Procedures.
• Manage Supplier complaints and support audits.
• Deliver quality training to employees.
• Compile quality metrics for QMS monitoring.

Skills

Experience in a similar role

Excellent communication skills

Attention to detail

Time management skills

Education

Degree in a Life Sciences discipline

Tools

Microsoft Office

Electronic Quality Management System

Job description

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.

Responsibilities

• 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 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.
• The candidate must be able to multitask, have excellent attention to detail and time management skills.
• Excellent administration and record keeping skills.

Qualifications

• Educated to degree level in a Life Sciences discipline.

Next Steps

If this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you.

Inclusion and equal opportunity

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.

We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.

If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at [e-mail]. We’re here to assist and make things as smooth as possible for you.