Job Ref: 215762017

Date: 2022-02-08 12:34:01

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Division: Quality Control

Hours: 37.5 per week

Reports to: QC Manager

Job title: QC Lead Microbiology Technician – Laboratory

Contract: Interim, 12 month contract

IR35: Inside IR35

Rate: Up to £300 per day, based on experience

Location: Milton Keynes

Start: Flexible but ideally as soon as possible

PLEASE NOTE, NO SPONSOR OFFERED

Company/Division overview

We are a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

We are is now recruiting a lab lead technician for Microbiological Testing Laboratory within the Quality Control department, at the Milton Keynes site.

Purpose of role

To provide technical and practical expertise for Microbiology and Sterility test methods to QC labs in the UK and liaise with other sites. To assist different functions on site for investigations, troubleshooting, change and CAPA implementation in relation to aseptic manufacture and monitoring. This role also involves support in testing of finished products and intermediates in accordance with GMP, dossier and relevant pharmacopoeial requirements.

Key Accountabilities and Duties

* Validation – 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, R&D and Production to drive project completion and deliver on milestones.

o Assist lab leads in executing validation of biomaterials used in in-process and final product testing. This will include technical writing of protocols, testing and execution of protocols and writing final reports. Change Management associated with validation activities will fall within the scope.

o Method validation and transfer – sound knowledge of regulatory requirements for method validation and transfers across labs.

o Equipment validation – assist lab leads in executing validation of new equipment. This will include technical writing of protocols, execution and final reports. Change Management associated with validation activities will fall within the scope.

o Expertise in Microbiology and Sterility testing techniques.

* Improvements / Projects – Assist lab leads in execution of activities required to make improvements in the laboratories or other QC projects.

* Investigations

o To be able to lead complex investigations for out of specification and out of trend test results. Finding root causes and raise appropriate CAPA actions. Ability to lead these as cross functional investigations, when required.

o Assist lab leads to ensure successful CAPA completion and verification including training of staff in new/improved test methods.

* Production Support – Offer support to the lab leads when liaising with Production over manufacturing issues in relation to QC testing.

* SAP – working knowledge of SAP.

* Health and Safety – ensure up to date assessments within the laboratory areas for –

o Manual handling assessments

o COSHH assessments

o Risk assessments

Other responsibilities

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

Maintain all documentation and training records as per GMP requirements.

Incorporate our Production System and Inclusion within the department activities and work with colleagues to innovate and implement processes.

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

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

The above list of duties is not exhaustive and is subject to change. The post holder may be required to undertake other duties within the scope and grading of the post.

Knowledge

* Sound understanding and working knowledge of GMP Quality Systems

* Subject Matter Expert in Microbiology/Sterility and aseptic techniques

* SAP knowledge

Experience

* Minimum 5 years of experience with excellent understanding of testing within a laboratory environment

* Laboratory investigations

* Method and equipment validation

* Method Transfers

Skills and Ability

* Project management

* Proficient in use of Microsoft Office especially Excel and Word.

* Good Protocol and Report writing skills.

* Ability to troubleshoot and resolve issues

* Knowledge of Minitab Statistical software

Personal Attributes

* Able to communicate at all levels and across all functions

* Ability to communicate concise technical information with clarity

* Good Time Management in a high flow through laboratory

* Flexible approach to changing priorities

* Attention to detail

Qualifications

Degree in Microbiology or related Biological Sciences

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