Microbiology Laboratory Technician
1 month ago
MUST HAVES:
Experience in EM and/or WFI sampling
Experience working in a regulated environment
Experience in GxP data reporting and documentations.
Summary:
The Associate/ Technician – Quality Control will perform day-to-day QC activities while ensuring accuracy, timeliness and in compliance with current cGMP and regulatory expectations of cell-based products. The day-to-day activities will include but not limited to sample collection/ preparation, data entry and reporting, and procuring and maintaining lab supplies.
Essential Functions
Perform routine Environmental monitoring, personnel monitoring sampling, and WFI sampling
Perform data entry into electronic system and compile data package for approval
Revise documentation such as SOPs, training materials, and other required documentation
Coordinate for sample pick-up/ shipments
Order, stock, and inventory supplies for the QC laboratory
Support additional projects and assignments assigned by lead and reporting manager
Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
Support additional projects assigned by reporting manager
Qualifications
- Bachelor’s Degree required, within Microbiology/Biology/Chemistry/Life Sciences or related field preferred.
- Prior industry experience preferred.
- Preferred within the Pharmaceutical/Biotech industry. Relevant experience is defined below.
- Experience with the application of cGMPs, USP/NF, EuPH., FDA guidelines and ICH guidelines with the pharmaceutical industry
- Experience writing standard operating procedures and other cGMP documentation
- Experience with Water and/or EM sampling
- Experience in aseptic conduct and technique
- Experience with sterile cleanroom gowning
- Excellent organizational and multi-tasking skills, attention to detail, and the ability to adapt to changing priorities.
- Ability to handle conflicts.
- Solutions oriented and good at making decisions under time pressure
- Excellent organizational and communication skills required.
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