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Quality Control Analyst - Microbiology at RoslinCT

Quality Control Analyst - Microbiology

RoslinCT EH16, Liberton, City of Edinburgh, City of Edinburgh Full Time
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Based at the Edinburgh BioQuarter, RoslinCT is a leading Contract Manufacturing and Development organisation within the cellular therapies/ATMPs field, performing cutting edge investigational medicinal product manufacture for clinical trials across Europe and the US.
The Company is now embarking on an exciting period of planned growth, and we are recruiting for some key operational roles to help support and lead that growth into the future, including this one.
We are searching for a Quality Control (QC) Analyst - Microbiology to join our expanding Quality Control team!
Candidates for this role must also be able to demonstrate a strong commitment to our Core Values, and so should be:
* Passionate about Customer Satisfaction
* Able to support a ‘one team’ approach
* A great communicator
* Committed to personal growth and development
* Accountable for their work
Main Function:
The role of QC Analyst - Microbiology will report directly to the QC Supervisor- Microbiology and support the current Good Manufacturing Practice (GMP) production of cellular therapies and cell banking. You will also provide the environmental monitoring support for the GMP clean room facility including sampling and associated microbiology activities.
Specific Responsibilities:
Your duties and responsibilities as the QC Analyst – Microbiology will vary, but will include:
* Perform QC activities in accordance with Good Manufacturing Practice (GMP) including environmental monitoring, growth promotion and identification techniques.
* Support the environmental monitoring program in the Cellular Therapy Facility, including sampling, microbiology assays and trending of EM data.
* Complete quality related documentation including QC records, change controls, incidents/deviations and risk assessments in accordance with GMP and standard operating procedures.
* Write assay qualification documentation and performing routine QC testing of cellular therapies and cell banks. Perform qualification of QC assays. Co-ordinate QC testing with external companies.
* Write SOPs and update SOPs for QC activities. Compile QC reports and certificates of analysis, and QC equipment qualification.
* Liaise with suppliers and general record keeping.
* Source and/or establish in-house QC assays as required.
* Train team members.
* Support the compilation of information used to communicate with clients. Communicate procedures and results with clients.Demonstrate excellent customer service skills for both internal and external customers.
* Perform tasks as reasonably expected by management.
* Compliance with all Health and Safety policies and procedures.
* Providing out of hours cover for critical equipment alarms as required on a rotational basis.
Qualifications Required:
The post holder will have:
* A degree or equivalent qualification within the life sciences
Skills/Experience Required:
The post holder will also have:
* Applied knowledge of microbiology gained from working within a scientific laboratory.
* Experience in environmental monitoring and GMP QA, particularly incident investigations.
* 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 where you are able to 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. Plus 4 public holidays
Location: Edinburgh BioQuarter. Please check our location and ensure you can realistically commute to site as we have limited parking available.
Closing Date: 18th September 2020
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Job ID: 212218850