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QC Analyst - AntiSera
- The performance of routine immunological testing in support of commercial operations and other non – routine activities, such as projects and investigational work with required standards with respect to documentation, good house keeping, cGMP, health and safety, timekeeping, regulatory legislative requirements and in accordance with the rules and requirements of the GMP Compliance Rulebook, the Code of Conduct, quality manual and any other company policies and procedures.
- Take ownership of, and be responsible for, all actions undertaken as part of the role, to ensure commitments to the organisation and colleagues are always met.
Testing to include:
- Microneutralisation assay
- Potency Assay (FFA).
HA and HAI
- Gel electrophoresis
- Act as Subject Matter Expert for Antisera Qualification Immunological methods
- Coordinate with Outside Testing Laboratories the generation and qualification of Antisera.
- Laboratory maintenance- housekeeping, self inspections and stock control – re-order schedules and communication with key suppliers.
- The documentation of laboratory results in an accurate, neat and timely manner in accordance with a cGMP and company procedures (including completions and validation of LIMS electronic data), to include the investigations of deviations.
- Trending of Laboratory data, as appropriate.
- To assist in supervision of laboratory activities (including scheduling personnel and work) and to deputise for laboratory supervisors, as appropriate.
- Liaise with functional groups both within and outside QC to ensure production goals are achieved and plans are established and executed to achieve product supply requirements on a 0-3 month horizon.
- Hold daily group meetings and escalate issues appropriately.
- Development and implementation of improvement plans and ensuring Operational; Excellence is integrated into the teams responsibilities this should include adopting a continuous improvement philosophy and a Right First Time From Me attitude to all operations.
- The writing and execution of laboratory protocols and reports, as assigned.
- The review and approval of laboratory documentation e.g. laboratory test reports/log books, temperature charts to ensure adherence to laboratory procedures and cGMP.
- To ensure training status of group is compliant with matrix requirements and to lead in training of laboratory staff.
- To ensure all activities performed are compliant with company Health and Safety Guidelines.
- The jobholder should have a minimum of a BSc or equivalent in a related scientific discipline or extensive experience.
- The jobholder should have some experience of working within a regulated environment, pharmaceutical or medical laboratory in a related role to cGMP or within alternative quality system such as Contract testing laboratory.
- A background in Protein Chemistry or Virology is essential.
- The jobholder should have good communication skills and be conversant in computer systems using MS packages.
- The jobholder should have a thorough understanding of relevant regulatory/industry standards and requirements for cGMP and product testing.
- This job requires a very good understanding of relevant regulatory/industry standards and requirements. However, some of the work will be of a routine and defined basis.
- Whilst the role reports in to Virology Team Leader, there is a requirement for the Job Holder to make decisions, within agreed guidelines, on a regular basis and actively manage their own workload with limited day to day supervision.
- Live Virus experience preferable
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