Microbiology Analyst II

Perform QC activities such as Environmental Monitoring of the manufacturing facility, microbiological/biological testing of products (e.g., bioburden, endotoxin), and performing sample receipt and send outs. This position also supports EM trend reports, EM excursions investigations and data review.

• Perform environmental monitoring - sampling of clean rooms
  
• Perform sampling of RODI Purified Water System
  
• Coordinate shipment of samples to contract laboratories
  
• Receive test results/data from contract laboratories and perform data review and entry into the appropriate database
  
• Conduct routine analysis of microbiology methods in accordance with standard operating procedures (SOPs) or compendial methods (Bioburden, Endotoxin).
  
• Assist with data trending and aid in compilation of trend reports
  
• Assist with EM excursion investigations
  
• Assist with the preparation of EM excursion reports
  
• Work on individual projects independently with supervision
  
• Completes QC documentation in accordance with cGMP
  
• Manage time effectively to complete assignments in expected time frame
  
• Sample disposal upon completion of testing
  
• Participate in laboratory housekeeping chores
  
• Perform other related duties and tasks as required or assigned
  

Qualification Requirements:

• Bachelors degree in the Life Sciences preferred
  
• 2-3 years of experience in pharmaceutical or medical device industry
  
• Understanding of aseptic techniques and microbiology test methodologies
  
• Knowledge and understanding of GMP, compendial test requirements.
  
• Experience with USP and LIMS a plus
  
• Experience qualification bioburden and endotoxin testing methods on medical devices preferred.
  
• Strong communication skills
  
• Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc
  
• Ability to lift 25 pounds
  
  Working Conditions:
  
• Mix of office and laboratory/clean room environments
  

ID: 2022-1554

External Company Name: Ocular Therapeutix, Inc.

External Company URL: http://www.ocutx.com/

Street: 36 Crosby Drive