Document Controller and Quality Systems Administrator

RoslinCT is looking for a driven individual to join us as a Document Controller.

We are a world-leading contract manufacturing and development organisation, specialising in the field of cellular therapies, advanced therapeutic medicinal products and regenerative medicine.

We have embarked on an exciting period of growth and are now recruiting across all our teams to support our expansion. This position of Document Controller forms a key part of that growth.

The Role:

Reporting to the Quality Assurance Manager, you will provide support to the Quality Assurance Team to maintain appropriate records and Quality management documents for the efficient operation of RoslinCT's Quality Management System in addition to providing clerical and administrative support.

Responsibilities:

As the Document Controlleryou will work within a fast-paced team to deliver life-changing and cutting-edge therapeutic products to patients. As such, your responsibilities will be varied but will include;

• Ensuring controlled documents as part of the quality system are prepared, issued and managed and updated in compliance with Good Manufacturing Practice.
• Performing document management duties using Q-Pulse electronic document management systems and paper-based systems including, but not limited to manuals, policies, standard operating procedures, forms and logs.
• Recording data in accordance with Good Manufacturing Practice and approved standard operating procedures.
• Maintenance of reliable document storage and archiving systems, both paper-based and electronic, to maintain the integrity of the records.
• Support in the management of incident management, CAPA management and change controls.
• Providing regular reports as required for quality meetings, executive meetings and client meetings.
• Providing administrative support for the Quality team including the Quality Assurance Manager.
• Carrying out all tasks in accordance with GMP and quality management system requirements.
• Ensuring that Health & Safety requirements are applied to all tasks at all times.
• Demonstrating excellent customer service skills for both internal and external customers.
• Ensuring that confidentiality of all information relating to clients and patients is maintained at all times.

Values:

A key part of working at RoslinCT is being able to embody our company values, which are integral to the work we do here. You should be able to demonstrate:

• Passion for customer satisfaction
• Ability to support a 'one team' approach
• Great communication
• Commitment to personal growth and development
• Accountability for your work

Qualifications Required:

The candidate will hold Higher Grades in Maths, English and Science or equivalent qualifications or experience.

Skills and Experience:

The ideal candidate will demonstrate:

• A knowledge of Quality Management Systems and Document Control Systems.
• A working of knowledge of Q-Pulse is desired, although not essential.
• Outstanding skills in IT, in particular Microsoft Word document formatting and typing skills, and administration.
• An understanding of scientific manufacturing processes and a broad knowledge of GMP within a manufacturing environment would be beneficial.

Benefits:

In addition to a competitive salary and the opportunity to join an exciting, rapidly expanding company delivering life-changing therapies, we can offer:

• Group Personal Pension Plan: 3% Employee contribution with an Employer contribution of initially 5% for the first year of joining the scheme then a 1% increase per year until a maximum of 8% is reached.
• Group Life Cover, 3X Salary.
• Health4All Cash Plan: Claim cash back towards dental check-ups and treatment, new glasses, contact lenses and therapy treatments such as physiotherapy and chiropody and more.
• Employee Assistance Programme.
• 31 days annual leave with an extra day from 3 years' service and a further day from 5 years' service.
• 4 days public holidays leave.