Senior Quality Control Analyst Analytical

2 weeks ago

Edinburgh, United Kingdom RoslinCT Full time

Senior QC Analyst – Analytical

Location: Edinburgh BioQuarter, Little France

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

  • Develop assays appropriate for Characterisation and Safety testing of human embryonic stem cell lines and cell and gene therapies for human application.
  • Assimilation, manipulation, and accurate interpretation of complex data sets in many forms.
  • Routine QC testing of cell and gene therapies to a GMP standard.
  • Review and update current QC SOPs and establishing new SOPs.
  • Training and certification of all personnel carrying out analytical activities. This role may include line management of some team members.
  • Ensure that all processes are subjected to appropriate levels of analytical sampling and review.
  • Lead investigations on incidents of product contaminations.
  • Compiling and reporting of all analytical data to facilitate product release.
  • Review current regulatory requirements to ensure ongoing compliance.
  • Develop the Analytical laboratory by identifying trends and new technologies and bringing them in-house.
  • Validate new techniques and processes and training of others in these methods.
  • Validation of equipment and maintaining calibration and servicing records.
  • Generate trend and summary reports for the benefit of RoslinCT management, including QPs, and chairing regular review meetings.
  • Support QC batch release of cellular therapy products by performing and co-ordinating QC batch release testing as required.
  • Participate in the day to day running of the QC laboratories to ensure a high standard of organisation is always observed.
  • Write and approve Standard Operating Procedures, as well as documentation review and sign off (where appropriate).
  • Completion of GMP documentation within the QC department including, Incident Reports, Change Controls and Risk Assessments.
  • Provide out of hours cover for critical equipment alarms as required on a rotational basis.


About you

  • An excellent understanding and proven track record of working effectively in a GMP Quality Control molecular biology/analytical laboratory, with commercial experience.
  • Experience in assay validation, stability testing, tissue culture, QC product testing and writing procedures to meet GMP and ICH guidelines.
  • A good standard of written English and the ability to write accurately and clearly.
  • Excellent communication and interpersonal skills with the ability to build strong working relationships.
  • A good working knowledge of UK laws and regulations for cell therapy products and tissue donation.
  • Competent in the use of Microsoft Office products.
  • Good organisational and planning skills with the ability to multi-task in a fast-paced environment.
  • You will be able to create a positive environment through self-awareness and social skills.
  • Effectively manage and influence stakeholders’ and customer expectations.
  • Excellent attention to detail with a real desire to continually develop and improve our processes.
  • Possess depth and breadth of experience in a variety of laboratory activities and have some specialist knowledge of Flow Cytometry.

Qualifications

  • A degree in a life science subject or equivalent qualification and experience is required.
  • A post graduate qualification is desirable.

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.

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 jobs@roslinct.com. We’re here to assist and make things as smooth as possible for you.

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