We are looking for a driven individual to join us as a QC Compliance Specialist in our Quality Control team.

RoslinCT is a world-leading contract manufacturing and development organisation specialising in the field of cell therapies, advanced therapeutic medicinal products and regenerative medicine across a range of therapeutic targets.

As part of our continued growth, which includes the opening of our state-of-the-art BioCube facility, we are now recruiting across all of our teams . This brand new role is well suited to an individual with experience in QA or QC GMP biologics manufacturing and auditing looking to move into a more specialised role.

The Role:
You will be a key member of our Quality Control team and will oversee all QMS activities across our QC Microbiology and Analytical/Molecular Biology operations, ensuring compliance standards are maintained.

Responsibilities:
At RoslinCT, we are dedicated to delivering life-changing and cutting-edge therapeutic products to patients. As such, your responsibilities in this position will be varied and will include;
*Initiation and management of a GMP and MHRA standard self-inspection programme to obtain and sustain audit readiness.
*Liaison with other departments in all QMS investigations, including Incident Report Triage meetings and dissemination of information to all relevant QC parties.
*Liaison between QC and Manufacturing in environmental monitoring incident report investigations.
*Provision of GQCLP training to all QC staff.
*Acting as deputy to the QC Manager during Audits and Regulatory Inspections.
*Trending, monitoring and reporting of all QC QMS metrics.
*Ensuring QMS KPIs are met through review and subsequent co-ordination of document completion within the QC team and monitoring progress against agreed timelines.
*Provision of support for timely closure of QMS metrics.
*Writing, progressing and co-ordinating the completion of QC incident reports and support with root cause analysis investigations ensuring completion within agreed timescales.
*Identification and implementation of effective Corrective and Preventative Actions (CAPAs).
*Drafting and review of change controls and support of change control activities.

Qualifications:
You will hold a BSc in a Life Science discipline or equivalent relevant laboratory experience.

Skills and Experience:
You will be able to demonstrate:
*Experience in QC/QA within a GMP or other highly regulated environment.
*An Auditor qualification or experience in Auditing.
*Experience of MHRA/FDA inspections.
*Experience of managing CAPAs, Change Controls, Risk Assessments and RCA.

Benefits:
In addition to a competitive salary and the opportunity to join an exciting, rapidly expanding company delivering life-changing therapies, we can offer:
*Company Pension: RoslinCT will contribute 5% for the first year of joining the scheme with an increase of 1% per year until a maximum of 8% is reached, with a 3% Employee contribution.
*Life Insurance: Access to RoslinCT’s Group Life Cover at 3x Salary.
*Wellness Programmes: Access to RoslinCT’s Health4All Cash Plan and Employee Assistance Programme.
*Competitive Annual Leave Allowance: 31 days, plus 4 Public Holidays across Christmas, with an extra day from 3 years’ service and a further day from 5 years’ service.
*Company Events: Our Social Committee works hard to bring fun company events to all our staff.
*Casual Dress: dress down Fridays.

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. As such, 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

Location:
We are based at Edinburgh BioQuarter, which acts as a hub for Scottish Life Science with close links to the University and the Royal Infirmary.