2nd shift- Microbiologist (EM)

Job Overview:

Responsibilities:

• Provides QC microbiology support to the Aseptic Manufacturing and validation process.
• Performs Microbiological Tests and studies by following the established procedures referenced in the official sources.
• Collection of water samples for testing (WFI, DI, Raw) 
• Collection of samples (Raw Materials, Excipients, Validation, In-process and Finished product samples) for microbiological/chemical testing.
• Conducts validations studies and routine tests related to Bioburden Tests, Bacterial Endotoxin Tests, Particulate Matter Test, and Sterility Tests.
• Preparation of microbiological media and diluents by following laboratory procedures
• Quality Control Testing of microbiological media and reagents.
• Environment Monitoring of Aseptic / Non-aseptic Manufacturing areas and Trending of microbial data obtained from EM/Utilities/Raw Materials/In-process and finished products testing and preparing the periodical summary report.
• Maintenance of Laboratory inventory and cleanliness of the Laboratory.
• Responsible for maintaining the microbiology isolates obtained from EM and Utility Monitoring Program.
• Follow established health and safety procedures and policies related to QC Microbiology Laboratory operations.   Perform other related duties as required and assigned by Microbiology Laboratory Management.
• Perform other duties as assigned.

Qualifications: 

• A.S. in a life sciences discipline and 2+ years of relevant experience working in cGMP cleanrooms and QC Microbiology lab, B.S / M.S. in a life sciences discipline and 0-2 years of relevant experience working in cGMP cleanrooms and QC Microbiology, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Demonstrates flexibility in following unique campaign requirements that may include off-hour and weekend work. 
• Demonstrate thorough understanding of QC Microbiology Laboratory Operations and Sterility Assurance program.
• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate solid understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands: 

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary). 30 To 36 (USD) Hourly