Microbiology, Sterility and Lungworm Senior Technician
Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Today, they are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us.
Their 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 have an exciting opportunity for an experienced Microbiology Senior Technician to join their busy and thriving team. You will be required 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 pharmacopoeia requirements.
This is a full-time temporary contract role for up to 2 years role working onsite in Milton Keynes. The role offers a pay rate up to £22.02 per hour, depending on experience, plus 25 days holiday and other benefits.
Key Accountabilities and Duties:
- To perform and oversee testing of all samples submitted to the micro and sterility department (including EM, water, intermediate and finished products) in accordance with GMP, dossier, MSD quality guidelines and where relevant, as per pharmacopoeia requirements (testing includes Bioburdens, Lungworm, plate reading, sterility testing, growth promotion and Inactivation's)
- Training of new staff and ongoing training of staff in new or improved methods. Ensure training documents are kept up to date.
- Identifies and facilitates Continuous Improvement opportunities which will improve productivity or result with cost saving.
- Drive change management for introduction of new / improved methods and validation of new equipment and validation on new biomaterials
- Chair Environmental monitoring meetings and author Environmental monitoring trend reports.
- Release of batches in accordance with LROT and LTA, escalating any potential affect to supply
- Provide the required data for the Product Quality Reviews, as required.
- Update SOP's, and Specs ensuring they are current and relevant.
- SAP - ensure timely completion of results in SAP and up to date specifications for microbiology lab tests.
- 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.
- Ensure QMS commitments and timelines such as CAPA's, change controls and deviations are adhered to.
- Production Support - Offer support to Production for manufacturing issues relating to QC testing.
- Health and safety representative for QC:
o Participate in departmental safety meetings.
o To qualify as COSHH, Manual handling and Risk Assessor.
- Promote safety within the laboratory areas, by carrying out safety observations, ensuring correct signage and maintaining COSHH documentation to prevent or reduce unnecessary exposure to hazardous substances.
- Deputise for the team leader to attend capacity and production tier meetings, as required.
- Support the team leader to prepare the schedule for the Microbiology/Sterility Lab and laboratory work, including arranging cover for weekends and holidays.
- Assist Procurement and QA with changes relating to external suppliers of test materials and other critical consumables used for testing.
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
- Microbiology/Sterility lab experience
- GMP Compliance
- Minimum 3 years of experience with excellent understanding of testing within a laboratory environment
- SAP/LIMS Knowledge desirable
Skills & Ability
- Laboratory investigations
- Method and equipment validation
- Project management
- Proficient in use of Microsoft Office especially Excel and Word.
- Good Protocol, hypothesis and Report writing skills.
- Ability to troubleshoot and resolve issues
- Method Transfers experience Desirable
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