As a dedicated quality assurance professional, this role focuses on maintaining and aligning with laboratory documentation and computerized systems data integrity requirements. This includes understanding regulations and business processes necessary to maintain laboratory data integrity.
The successful candidate will be responsible for carrying out environmental and microbiological tests as required. Additionally, they will define and update procedures for the plant relative to microbiological and environmental testing.
Key Responsibilities:
* Maintain and align with Laboratory Documentation and Computerized Systems Data Integrity requirements
* Understand Regulations and business processes required to maintain Laboratory Data Integrity
* Carry out environmental and microbiological tests as required
* Define and update procedures for the plant relative to microbiological and environmental testing
* Complete validation of equipment and test methods for microbiological tests
* Test method transfer of microbiological methods
* Develop microbiological laboratory procedures
* Maintain up-to-date and detailed records of all tests performed
* Adhere to and support all EHS & E standards, procedures, and policies
* Perform other duties as assigned
Requirements:
* A third-level qualification in microbiology or an equivalent science discipline is essential
* A good knowledge of aseptic process manipulation and experience within a GLP/GMP environment are also required
* Lab experience within industry – bioburden/endotoxin/growth promotion/environmental monitoring – is desirable
* Experience within a sterile cleanroom environment is highly valued