QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team.
In this role, you'll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities: Perform microbiological sampling and testing for product release, microbiological control and protocols as needed following company specifications and cSOP's.
Assure that complies with company policies and internal and external regulations.
Perform environmental (water, room air, compressed air, nitrogen and surfaces) test, Bacterial Endotoxin test, Bioburden Test, Particle Matter Test of Product and Garments, microbiological/ mold identification, microbial ingress studies, Growth Promotion and Vessel Requalification studies as required.
Performs microbiological testing for product.
Control materials and media inventory.
Carry-out weekly inventory of reagents, wastes, media and sampling equipment.
Dispose toxic agents in compliance with Company policies and procedures.
Support the training activities for new Laboratory Technicians in the assigned area.
Complete all testing, including special projects and protocol testing, in a timely and appropriate manner.
Ensure compliance with company SOP's, specifications and company policies, FDA, GLP and GMP regulations.
Support auditing microbiological test procedures and SOP's in the laboratory and submit changes, as required.
Performs growth tests to culture media.
Perform preventive maintenance to laboratory equipment and ensure to perform on time as required.
Provides supports on laboratory and production product sterilization autoclave qualification studies, Prepared media requested to perform the different testing at the Micro Lab.
Ensure to comply with training and certifications to perform test in the Micro Lab.
Ensure to perform the plate reading in a timely and appropriate manner.
Fill out, analyze and understand all necessary documentation to comply with all specifications and company standards.
Sterilize materials used at the Micro Lab.
Qualifications: Bachelor's degree in science (preferably in Microbiology, Biology, Medical Technology or Biotechnology) One to two years of previous experience in related area Able to follow all GMP requirements while conducting the assigned duties and completing official documents.
Use of safety glasses, safety shoes, uniform, special safety suit, gloves, etc.
Able to use required appropriate equipment such as: Spectrophotometer, Centrifuge, Autoclave, Particle Counter, Microscope, general and specialized laboratory equipment, telephone, office supply, copy machine.
Availability for 1st and 2nd Shift .
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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