This position independently performs sample accession responsibilities in compliance with appropriate SOPs and regulatory guidelines, in support of BioCMC operations.
- To ensure all samples in BioPharmaceutical CMC Solutions (CMC) are entered, located and tracked by established deadlines and in compliance with SOPs and regulatory agency guidelines; assuring chain of custody for all samples throughout their lifecycle.
- Perform a variety of sample accession responsibilities in compliance with appropriate SOPs, GMP / GLP / GCP requirements and regulatory guidelines, in support of operational requirements.
- This is a laboratory based role with direct responsibility for ensuring that effective and efficient material coordination and associated processes are followed for incoming and outgoing materials.
Trains new employees, working with and directing less experienced staff, and prioritising workloads and / or special projects on a daily basis.
- Sample accession core tasks, including delivery receipt, inventory, labelling, storage, disposal, shipping and client communication.
- Aliquots and sub divides samples in preparation for testing.
- Use of Departmental systems (LIMS, trackers etc.) as appropriate to maintain sample integrity.
- Ownership of entry and accuracy of data into Departmental systems.
- Accurate interpretation of project specific documentation.
- Reviews shipping inventory documents against materials received to ensure accuracy and communicate discrepancies to appropriate personnel.
- Planning and prioritisation of team and individual workload.
- Contributes to a cohesive team environment.
- Communicates effectively with internal and external customers.
- Introduces and develops process improvement initiatives.
- Reports and escalates any maintenance or equipment issues relating to their workplace.
- Participates in the maintenance of equipment and equipment records used within the team.
- Performs other duties as assigned.
- The post holder should ideally have a relevant scientific qualification and / or an appropriate amount of experience.
- Minimum of 12 months experience in the job discipline.
- Experience and application of sample accession receipt, transfer and shipping processes.
- Working knowledge of a functioning LIMS.
- Experience and application of aseptic technique.
- Knowledge and understanding of regulations (GMP / GLP / GCP).
- Basic computing skills, including word processing and use of spreadsheets (e.g. Word, Excel).
Posting ID: 584171290Posted: 2020-11-03