Quality - Microbiologist

PRINCIPAL OBJECTIVE OF POSITION: Responsible for performing the microbiological testing of pharmaceutical finished products, raw materials, water, compressed air, and environmental samples. Incumbent must comply with Standard Operating Procedures (SOPs), and Human Resources Policies. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. MAJOR DUTIES AND RESPONSIBILITIES: 1. Receives and controls microbiological samples submitted for testing in the Microbiology Laboratory. 2. Performs microbiological testing following laboratory methodology, such as Testing Standard, General Method, Specific Method, Pharmacopeia Compendia, and SOPs and sampling of water, environmental (air & surface), and compressed air samples. 3. Reports analytical test results in applicable computerized systems. 4. Reviews laboratory documentation from peers to ensure testing was performed according to laboratory methodology and accuracy. 5. Performs and documents Laboratory Investigations and Quality Events Investigations and generates Laboratory investigations for test results outside of specification and Quality Events. 6. Recommends updates to current SOP’s, protocols and monographs. 7. Prepares and sterilizes culture media and laboratory solutions and performs growth promotion, sterility, and viability tests to culture media. 8. Identifies microorganisms in accordance with laboratory methodology and ensures there is adequate inventory of purchased microorganism, culture media, reagents, and laboratory supplies used in the Microbiology Laboratory. 9. Verifies calibration of the laboratory equipment to ensure they are suitable for use. 10. Participates in Microbiological Testing validation exercises. 11. Assists in the training of new hired Microbiologist. 12. Handles and properly disposes potentially dangerous, regulated hazardous wastes into a designated on-site disposal facility or interim storage container and; files appropriate logs and forms and takes the necessary corrective action in the event of an incident such as a spill, fire or explosion. 13. Ensures the reliability of the analytical equipment and the integrity through the proper maintenance and housekeeping (5S) of the testing areas. 14. Maintains accurate records of all work performed and document testing results as per Good Documentation Practices and the laboratory notebooks and worksheets as per QC SOP’s. 15. Completes, on a year basis, the required and assigned Microbiology Qualification Program and maintains update his/her Qualification Program file. 16. Understands, interprets and applies compendial testing. 17. Assures that materials that are stored in the laboratory are within their expiry period and follows internal inventory system and documents received and discarded material. 18. Generates laboratory Work Orders in a computerized system (Maximo). 19. Follows and exhibits Core Client Behaviors KNOWLEDGE / SKILL: • Bachelor’s Degree in Natural Sciences (Biology, Microbiology, Medical Technology) • Basic knowledge on Microbiological Laboratory Techniques and equipment • Working experience in a microbiology, chemical, analytical laboratory • Self-starter with strong analytical skills. • Excellent interpersonal relations. • General knowledge in computer software, such as Word, Excel, and Power Point • Effective communication skills in both languages (English and Spanish) • Must be willing to provide on-call support for testing during weekend, holidays, and after working areas and to work shifts to cover manufacturing needs. • Ability to work in a teamwork environment *Weil Group is proud to be an Equal Employment Opportunity Employer.*