Contract / Temp to Direct / Direct Hire: Direct Hire
State: New Mexico
Country: United States
Zip or Postal Code: 87113
Reply to Recruiter via Text Msg: 5052621871
* Develops multiple processes in the laboratory, scaling up and overseeing the processes, according to cGMP guidelines and ISO 17025 requirements.
* Well versed in all USP microbiological testing, especially USP <51>, <61>, <62>.
* Maintains laboratory policy and procedure manuals and assists in developing and writing procedures; validates the procedures and document preparation.
* Develops training and competency programs and procedures; trains new technical staff.
* Oversees laboratory supplies.
* Ensures sanitization and the environmental testing of the clean-room.
* Writes and revises microbiology and other relevant SOP's, as required.
* Provides technical input on product testing issues and instrumentation/equipment.
* Ensures that laboratory is in cGMP compliance conducting inspections of all monitoring systems and equipment.
* Ensure that proper recording and review of data.
* Testing the integrity of raw materials or finished products.
* Conducts and documents failure and complaint investigations.
* Serves as liaison to service, calibration and technical representative
EDUCATION AND/OR EXPERIENCE
* Minimum Master Degree in Microbiology, preferably PhD.
* Strong organizational skills and ability to prioritize and multi-task in a fast-paced environment.
* Minimum of 5 years’ industry experience in a GMP or GLP environment.
* Proficient in the validation/qualification of lab microbiological techniques.
* Previous experience managing a microbiology group.
* Previous experience with pharmaceutical cleanroom environments.
* Skilled in the use of computers and proficient in the use of spreadsheets.
* Knowledgeable in FDA cGMPs (21 CFR 211).
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