MSD Senior Lab Technician - Microbiology Sterility Lungworm 

United Kingdom, England 

392975430

Job Description

• Position: Senior Lab Technician

  Location: Milton Keynes
  Department: Quality Control -Microbiological/SterilityTesting Laboratory

  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 pharmacopoeia requirements.

  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, 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
  • 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.
  • 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:
  • Participate in departmental safety meetings.
  • 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 theMicrobiology/SterilityLab 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.

Microbiology/Sterilitylab experience GMP Compliance SAP/LIMS knowledge Experience with excellent understanding of testing within a laboratory environment Laboratory investigations · Method and equipment validation Method Transfers

Current Contingent Workers apply

Not Applicable

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.