Glaukos Corporation
Sr. Microbiologist/Microbiologist II
Glaukos Corporation, Aliso Viejo, California, United States, 92656
Sr. Microbiologist/Microbiologist II
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Glaukos Corporation
How will you make an impact? This microbiologist role will have a strong background in performing method development, method validation, method transfer activities as well as routine testing of raw materials, in-process testing and finished product.
This exciting role
will support microbiological activities for the Glaukos organization, which includes R&D as well as commercial manufacturing.
What You’ll Do
Develop and implement microbiological strategies and procedures to ensure compliance with industry standards and regulations
Perform method development, feasibility and validation of raw materials, in-process and final product
Conduct routine microbiological testing and analysis of samples, ensuring accuracy and reliability of results
Perform routine and stability testing of GLP and GMP supplies
Write and revise SOPs, validation protocols/reports
Perform testing as needed to generate data for validation and special projects
Make recommendations and validate new laboratory equipment (e.g., Installation Qualification, Operational Qualification (IQOQ), and Performance Qualification (PQ))
Maintain accurate and up-to-date documentation of all microbiological activities, including test results, procedures, and reports
Review and interpret test results, prepare reports, and communicate findings to relevant stakeholders
Identify and implement improvements to existing microbiological processes, methods, and techniques to enhance efficiency and productivity
Collaborate with cross-functional teams, such as quality assurance, research and development, and production, to support product development and continuous improvement initiatives
Stay updated with the latest advancements and trends in the field of microbiology and recommend and implement new technologies and methodologies as appropriate
Ensure compliance with relevant regulatory requirements and standards, such as Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), and ISO standards
How will you get here?
Bachelor's degree in Microbiology, Biology or related scientific field
Minimum 8 years of related pharmaceutical experience in a cGMP environment
Proficiency in microbiological techniques such as aseptic testing, microbial monitoring, gram staining, and plating
Proficiency in testing according to AAMI/ISO/USP Standards
Knowledge and control of laboratory equipment including calibration and maintenance
Ability to understand and perform all required tasks by adhering to company Standard Operating Procedures and all current Good Manufacturing Practices
Understanding of quality systems including change control, deviations and CAPAs; support investigations as needed
Ability to handle multiple tasks concurrently and complete tasks in a timely manner
Strong written and verbal communication skills to effectively read and write SOPs and related lab reports and effectively communicate data with personnel at all levels
Excellent teamwork skills, organizational skills, and strong attention to detail
Knowledgeable in regulatory requirements and industry standards related to microbiology
Proficient in using microbiological testing equipment and software
Knowledge and proficiency in computer software (e.g., Microsoft Office programs)
Attention to detail and high level of accuracy in performing microbiological tests and analysis and excellent analytical and problem‑solving abilities to interpret test results, troubleshoot issues, and recommend solutions
Ability to work collaboratively in cross‑functional teams and adapt to changing priorities and deadlines
Strong organizational and time management skills to prioritize tasks and meet project timelines
Ability to lift 25 lbs.
Ability to stand or sit 8 or more hours a day
Work in a sterile environment wearing appropriate gowning and protective equipment
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–
Glaukos Corporation
How will you make an impact? This microbiologist role will have a strong background in performing method development, method validation, method transfer activities as well as routine testing of raw materials, in-process testing and finished product.
This exciting role
will support microbiological activities for the Glaukos organization, which includes R&D as well as commercial manufacturing.
What You’ll Do
Develop and implement microbiological strategies and procedures to ensure compliance with industry standards and regulations
Perform method development, feasibility and validation of raw materials, in-process and final product
Conduct routine microbiological testing and analysis of samples, ensuring accuracy and reliability of results
Perform routine and stability testing of GLP and GMP supplies
Write and revise SOPs, validation protocols/reports
Perform testing as needed to generate data for validation and special projects
Make recommendations and validate new laboratory equipment (e.g., Installation Qualification, Operational Qualification (IQOQ), and Performance Qualification (PQ))
Maintain accurate and up-to-date documentation of all microbiological activities, including test results, procedures, and reports
Review and interpret test results, prepare reports, and communicate findings to relevant stakeholders
Identify and implement improvements to existing microbiological processes, methods, and techniques to enhance efficiency and productivity
Collaborate with cross-functional teams, such as quality assurance, research and development, and production, to support product development and continuous improvement initiatives
Stay updated with the latest advancements and trends in the field of microbiology and recommend and implement new technologies and methodologies as appropriate
Ensure compliance with relevant regulatory requirements and standards, such as Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP), and ISO standards
How will you get here?
Bachelor's degree in Microbiology, Biology or related scientific field
Minimum 8 years of related pharmaceutical experience in a cGMP environment
Proficiency in microbiological techniques such as aseptic testing, microbial monitoring, gram staining, and plating
Proficiency in testing according to AAMI/ISO/USP Standards
Knowledge and control of laboratory equipment including calibration and maintenance
Ability to understand and perform all required tasks by adhering to company Standard Operating Procedures and all current Good Manufacturing Practices
Understanding of quality systems including change control, deviations and CAPAs; support investigations as needed
Ability to handle multiple tasks concurrently and complete tasks in a timely manner
Strong written and verbal communication skills to effectively read and write SOPs and related lab reports and effectively communicate data with personnel at all levels
Excellent teamwork skills, organizational skills, and strong attention to detail
Knowledgeable in regulatory requirements and industry standards related to microbiology
Proficient in using microbiological testing equipment and software
Knowledge and proficiency in computer software (e.g., Microsoft Office programs)
Attention to detail and high level of accuracy in performing microbiological tests and analysis and excellent analytical and problem‑solving abilities to interpret test results, troubleshoot issues, and recommend solutions
Ability to work collaboratively in cross‑functional teams and adapt to changing priorities and deadlines
Strong organizational and time management skills to prioritize tasks and meet project timelines
Ability to lift 25 lbs.
Ability to stand or sit 8 or more hours a day
Work in a sterile environment wearing appropriate gowning and protective equipment
#J-18808-Ljbffr