Job Ref: 215479933

Date: 2022-01-05 14:53:46

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Our global pharmaceutical client based in Milton Keynes is recruiting a Biologist to join their busy Quality Control team reporting to the QC Project Lead. This is a contract role initially signed off for 9 Months with a possible extension offering an hourly rate of up to £23.00 per hour, plus 25 days holiday pro rata and other benefits. Hours are Mon- Friday 37.5 hours per week.

Purpose of Role:

Currently QC is looking for an enthusiastic and dedicated analyst to –

To support analytical method validation / improvements and method transfers for Biology and Microbiology labs between sites.

Support activities in the areas of qualification of critical reagents (biomaterials) used in Bio-assays, such as ELISA coats, ELISA conjugates, reference toxins etc.

Key Accountabilities & Duties:

Expertise in Immunology techniques such as ELISA’s, haemagglutination tests, antigen mass assay is essential.

Understanding of microbiology techniques such as sterility test is beneficial.

Validation of biomaterials used in in-process and final product testing.

Biology/Microbiology method validation / improvements and test transfer between labs/sites.

Drive change management for introduction of new / improved methods and validation of new equipment.

Be able to produce technical documents such as protocols, testing and execution plans and final reports.

Ability to work on several projects simultaneously and be able to prioritise.

Reporting and communication of results to stakeholders. Liaise with several departments – technical support groups, QA, Regulatory to drive project completion and deliver on milestones.

Good understanding and ability to perform efficient lab investigations arising from deviations or invalid/atypical results.

Additionally, the candidate may be required to support laboratory investigations, perform troubleshooting exercises and participate in proof of principle studies.

Reporting and investigation of OOS and OOT results, determine root causes and implementing effective CAPA actions.

Perform project related literature searches

Other responsibilities

Comply with Standard Operational Procedures (SOP’s), GMP, ESH procedures and Company corporate policies and process improvements.

Maintain all documentation and training records as per GMP requirements.

To comply with company’s health and safety practices and procedures.

Ensure positive, timely and effective communication with team members and internal customers.

Knowledge:

Good understanding and working knowledge of GMP Quality Systems

Technical expertise in ELISA’s and other immunology techniques, including microbiology techniques.

Experience:

Minimum 3 years of experience with excellent understanding of testing within a laboratory environment

Laboratory investigations

Validation and method development

Skills & Abilities:

Proficient in use of Microsoft Office especially Excel and Word.

Good Protocol and Report writing skills.

Ability to troubleshoot to resolve issues

Basic Statistical understanding Knowledge such as Minitab Statistical software (desirable)

Qualifications:

Degree in Biology/Microbiology

Full driving licence

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