Job Title: Temp QC Micro Analyst
Duration: 12-month temporary contract
Shift: Shift based role (12/7 - extended days)
Responsibilities:
* Ensuring cGMP compliance in the manufacturing facility through testing.
* Assessing microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.
* Collecting and logging samples for microbial analysis from laboratory clean-rooms.
* Performing bioburden and endotoxin sample analysis in line with standard operating procedures (SOPs).
* Analyzing samples for microbial identification.
* Conducting environmental monitoring, including surface, settling, and viable and non-viable particulate air monitoring of aseptic operations and controlled areas.
* Testing commercially prepared microbiological culture media.
* Autoclaving microbiological media and laboratory waste as needed.
* Ensuring all work is carried out in compliance with regulatory standards, company policies, and SOPs.
* Completing test records on time and peer reviewing data from other analysts for accuracy and completeness.
* Assisting in designing and setting up the QC microbiology laboratory and selecting, implementing, and calibrating laboratory instruments.
* Participating in microbiological validations for drug substances, in-process controls, buffers, and clean utilities qualification programs.
* Providing technical advice to manufacturing personnel on microbiological root causes.
* Participating in transferring methodologies from other test facilities.
* Maintaining laboratory reagents, media, and supplies.
* Investigating laboratory issues and generating reports in response to invalid assays, deviations, OOS/OOT.
* Initiating and completing CAPAs and change controls in adherence with site procedures.
* Communicating analytical data reports clearly and concisely to management.
* Identifying and implementing lab process improvements and lean initiatives.
Requirements:
* BS/BA or equivalent experience in Microbiology or related field.
* 2+ years of validated experience or equivalent combination of education and experience.
* Strong trouble-shooting and problem-solving skills.
* Strong attention to detail & excellent written and oral skills.