CORE RESPONSIBILITIES:

The Synergy Lab Support team supports the Quality Assurance Department at the site in Ware, ensuring that all aspects of the manufacture of medicinal products are performed in a controlled manner and meet commitments to international regulatory bodies as well as the requirements of current Good Manufacturing Practice. The role holder will be part of the Synergy Lab Support team, working closely with the wider Synergy team and Customer scientists across various departments. They will undertake a range of lab support activities with a specific focus on Microbiology functions and Environmental Monitoring (EM) activities. PRINCIPAL ACCOUNTABILITIES:

Operational

Organise and perform regular environmental monitoring excursions, collecting water and air samples as per current work instructions & SOPs to monitor site facilities for any microbial growth Prepare and perform microbial limit testing, including medial preparation, subculturing and incubation. Record and prepare samples for different microbiological tests, completing required compliance documentation May perform testing of samples according to pre-defined test methods, specifications or Pharmacopoeia. (Training will be provided.) Ensures analytical records follow cGMP requirements and ALCOA+ principles (attributable, legible, contemporaneously recorded, original and accurate...