- Mar 15, 2023
The purpose of this position is to assist in the introduction of methods, practices and procedures to both QC and production and help to ensure aseptic and sterility assurance principles.
The purpose of this position is to assist in the introduction of methods, practices and procedures to both QC and production and help to ensure aseptic and sterility assurance principles are implemented and maintained from project phase to routine operation.
Health, Safety and the Environment
* Comply with legislative time requirements for construction projects.
* Comply at all times with Health, Safety and Environmental policy and procedure.
* Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
* Ensure all work is carried out in compliance with GMP, GLP and regulatory standards and guidance.
* Ensure all work is documented in accordance with the highest GMP standards including maintenance of data integrity at all times.
* Assist with the introduction and validation of all Microbiology methods in the house including but not limited to Environmental Monitoring, Water sampling/ analysis, Microbial Identifications, Growth Promotion, Sterility, Endotoxin (rapid method), Microbial Limit Testing, Biological Indicators
* Reading of test plates, data review, trending.
* Assessment of trends and communication of findings to other departments.
* Investigating specification results.
* Performance of laboratory sampling and testing.
* Assist with Media fill visual inspections
* Provide technical knowledge and guidance on aseptic assurance, sterility assurance and trending as applicable to the production environment for the duration of the project and during routine operation
* Participate in Operational Readiness for the duration of the project.
* Partcipate in risk assessments as required.
* Assist in the provision of oversight during Media Fills.
* Provide support during production investigations.
* Provide support and backup to the Senior Microbiologist and take on delegated tasks/projects as required.
Qualifications and Skills Required:
* Qualified to a minimum Degree level or equivalent in Microbiology or Biological Sciences.
* 2-3 years plus strong technical knowledge and experience in Microbiology methods and application.
* Demonstrated interest in the application of Microbiology principles to industrial settings.
* Demonstrated ability in the performance of QC Microbiology methods (in industry or other settings including college projects).
* Awareness of regulatory standards and how they apply to Pharmaceutical Microbiology.
* Experience working in a cross-functional team environment Awareness of cGMP and GLP standards.
* Proficient in Microsoft Office.
* Professional, proactive demeanor.
* Strong interpersonal skills.
* Excellent written and verbal communication skills.
Morgan McKinley are working in partnership with Horizon Therapeutics