We are seeking a Scientist who is responsible for performing microbiological and laboratory testing activities to support the quality, safety, and compliance of raw materials, drug substances, finished products, utilities, and manufacturing environments. This role ensures compliance with current Good Manufacturing Practices (cGMP), internal procedures, regulatory requirements, and supply chain objectives while supporting laboratory operations, investigations, validations, and continuous improvement initiatives.

Responsibilities

1. 
   Perform laboratory analysis, including but not limited to Microbial Purity Test, Bacterial Endotoxin Test, Biological Indicators certification and analysis, Endotoxin test, and other applicable tests for all raw materials, drug substances, and products, in accordance with internal and external regulations, policies, and supply chain cycle time goals. Complies with Laboratory Schedules for raw materials, product testing, utilities, environmental monitoring, and special projects. Additionally, performs water sampling and analysis, keeps trend analysis updated as required, works on test methods validation or special projects, handles environmental and utilities sampling and testing, process validation, and cleaning & trend analysis.

2. 
   Identifies all microbial growths detected, performs all laboratory activities under cGMP practices and compliance policies, conducts media preparation, growth promotion tests, provides support in investigations and manufacturing issues, ensures that equipment is qualified, calibrated and in good condition for its use, and verifies that culture media used for testing are approved and within expiration date.

3. 
   Operates laboratory equipment, such as autoclaves, pH meters, microscopes, balances, and identification systems (manual/automatic) and computerized systems.

4. 
   Prepare all culture media, reagents, stock culture preparation and materials required for testing.

• 
  Bachelor's degree in science-related field.
• 
  Knowledge of microbiological testing techniques and laboratory practices.
• 
  Working knowledge of cGMP regulations and quality systems in a pharmaceutical, biotechnology, medical device, or related regulated environment.
• 
  Experience with environmental monitoring, water testing, endotoxin testing, and microbial identification is preferred.
• 
  Proficiency in laboratory documentation and computerized systems.
• 
  Bilingual (English & Spanish)