Associate Analyst conducting routine and non-routine laboratory testing for a pharmaceutical company. Ensuring compliance with cGMP regulations and supporting product release processes.
Responsibilities
Perform routine and non-routine product and packaging release testing including, but not limited to, bacterial endotoxin, bioburden, particulate, silicone etc.
Perform routine testing to support the plant functions including, but not limited to environmental monitoring, water testing, personnel monitoring, etc.
Perform incoming testing for materials, including growth promotion testing in culture media and incoming test for biological indicators.
Perform microbial identification using the WID-MID software®.
Review data when required.
Participate in basic laboratory support functions, such as cleaning, preparing materials and glassware for testing.
Provide support for validations, method transfer and/or project work.
Assist in preparation of work instructions, SOPs, and qualification documentation.
Provide support in internal and external audits.
Participate (or assist) in identification, investigation (OOS’s) and resolution of problems in the lab.
Apply required cGMP regulations, data integrity and internal procedures.
Adhere to established laboratory safety procedures.
Meet individual and departmental goals as required.
Willing to work as a team member with self-motivation, adaptability, and a positive attitude to ensure continuous improvement relative to laboratory functions. As well as work independently using established methods and procedures.
Requirements
Bachelor’s degree in Science, Biology, or a related area preferred
1+ years of experience in a similar role preferred
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