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QA Specialist Biopharmaceutical - 12 month fixed term contract

QA Specialist Biopharmaceutical - 12 month fixed term contract

Job Title: QA Specialist Biopharmaceutical - 12 month fixed term contract
Contract Type: Permanent
Location: Stevenage
Industry:
Salary: £30000 - £35000 per annum, Benefits: bonus, pension, life insurance, health insurance plus others.
Start Date: 2020-02-06
Reference: V-46070
Contact Name: James Hume
Contact Email: james.hume@nextphaserecruitment.com
Job Published: February 06, 2020 12:57

Job Description

A new opportunity based in Stevenage for a Quality Assurance professional to join a genuinely exciting and unique organization who have developed unique CAR – T cell therapies for the treatment of cancers.  They currently have 3 therapies at Phase I and Phase II clinical trials with others in the pipeline to follow these and plans to prepare for commercial manufacture.

 

As a Quality Assurance Specialist, you will be leading the hands-on activities to support the manufacture of T – Cell based therapies for use in clinical trials. 

 

As a Specialist you will be leading the management of documentation that includes GMP policies, production and QC records, record review such as environmental monitoring, planned preventative monitoring, materials review, and sample management.

 

Alongside these duties you will also be responsible for Deviation Management including the coordination of change control, exceptions, out of trend and out specification activities.    Working with a Senior colleague to complete any investigations to identify the root cause and then implement the corrective actions.  As a Specialist you will also be part of the ongoing internal auditing programme, and support external audits by regulatory bodies. You will work with a Senior QA Specialist completing the validation of equipment & facilities.  As well as assessment of suppliers e.g. for raw materials and audits of GMP contractors too.  There will be additional duties as well with the idea to give you exposure to move to a more senior role in the future.

 

Experience

 

You will need to have a degree in a relevant life science combined with experience in a similar role with experience of working in a Quality Assurance role managing compliance to GMP in a Biologics, ATMP, Biopharmaceutical manufacturing environment.  With experience of activities such as document control, change control, audits, root cause analysis and investigations.  

 

Please note that this is an initial Fixed Term Contract for 12 months.

 

The Company

 

A pioneering and ambitious Biopharmaceutical company who develop next-generation, programmed T-cell therapies to treat cancer. The organisation has existed for 4 years and is very well funded, with a clear strategy and expansion plan for the next 3 years and beyond. Scientifically, the company has extremely exciting technologies, using a broad suite of proprietary and modular T-cell programming to engineer precisely targeted, controlled and highly active T cells. Commercially, they have a pipeline of product candidates in development (for the treatment of haematological malignancies and solid tumours) and is increasing its GMP / sterile production capacity. Based in a state-of-the-art facility in Stevenage, Hertfordshire, you will join a team that is doing something genuinely meaningful.