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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 and document microbiological tests, monitoring tests, and notify any out-of-limits condition.  Assure compliance with reference specifications and procedures.

+ Responsible for the preparation of media and laboratory equipment.  Assure compliance with reference specifications and procedures.  Follow GDP’S, GLP’s, cGMP's.

+ Correct use of aseptic techniques and other microbiological techniques such as streak plates, dilution, pour plates, microbiological transfer.

+ Perform microbiological testing pyrogen, water testing, compressed air systems and environmental systems, etc.

+ Operate different laboratory equipment (water bath, autoclave, balance, particle counter, biological safety cabinets, etc.) as per reference specifications, manuals and safety rules required.

+ Generate laboratory data in a comprehensive format for upper management information.

+ Gather laboratory data in a comprehensive format for upper management information.

+ Prepare, sterilize and test all media needed for testing.  Release media as appropriate.

+ Perform any special testing and other duties related to responsibility area.

+ Responsible for Conducting EHS inspections to identify and correct safety hazards and environmental aspect.   Follow the EHS applicable procedures and analyze EHS incidents (including near misses) to find causes and take corrective action.

+ Observe data privacy policies at all time.

+ Enter Environmental Test results in the ticker.

+ Maintain bioburden test result trend results updated.

+ Notify if is require the identification of the microorganism per local SOP.

+ Notify if OOL result is obtained and generated initial investigation.

+ Assist in qualification and re-qualification of the Autoclave Steam in Solution

+ Sets up, operates and maintains laboratory instruments, monitors experiments, makes observations, calculates and records results, and often develops conclusions.

Qualifications:

+ Bachelor’s degree in Microbiology/Biology/General Sciences.

+ Familiar with basic scientific principles and has had some laboratory experience.

+ GMP, GLP, FDA, RCRA, and OSHA knowledge required

+ 1-3 years of previous experience at Micro Lab

+ Knowledge of GLP/GMP/FDA requirements.

+ Good Documentation Practices.

+ Knowledge on PC Microsoft – Office Software.

+ Excellent communication and interpersonal skills.

+ Willing to work as required per company needs including holiday and weekend.

+ Bilingual (English Spanish) written and oral is a must

+ Must be able to work weekends Sun - Thurs 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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