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Summary of Position
Perform assigned quality control activities within the Microbiology Department to comply with applicable SOP's and cGMPs. Work under limited supervision with considerable latitude for the use of initiative and independent judgment. Must have the ability to work collaboratively, multitask, and adapt to changing priorities and schedules.
Essential Functions

• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Employ aseptic techniques while performing Sterility, Endotoxin, Particulates and Bioburden testing of drug products, intermediates and raw materials per USP and Company's Standard Operating Procedures (SOP)
• Perform in vivo biological performance testing of final product in support of product efficacy and quality per USP and Company's Standard Test Methods
• Perform Growth Promotion testing per USP Methods for various microbiological media.
• Prepare and analyze Biological Indicators in support of Validation and Qualification activities.
• Read plates to quantify microbial growth and subculture pure isolates as required.
• Data entry and review in Laboratory Management Systems (LIMS).
• General laboratory housekeeping duties and maintenance of the department, premises, and equipment.
• Collaborate with other team members to ensure the consistent and timely completion of all testing and other tasks in support of business needs.
• Assist with laboratory investigations, root cause analysis, and implementation of corrective and preventative actions.
• Ensure a safe and quality-minded working environment through conformance with training, general awareness, and compliance to safety/Quality guidelines and SOPs.
• Perform all work in compliance with site safety and radiation protection guidelines.
• Attend mandatory trainings as required by site regulatory requirements and management.
• Perform other general duties associated with the position as required by supervision.
• Management of inventory and ensuring all laboratory supplies are appropriately stocked.
• Assist in monthly equipment safety inspections.
• Assist in the training of less experienced technicians.
• Perform alert recovery trending.

Requirements

• Associate Degree or completion of 4 college-level life science courses required. Work experience is considered in lieu of degree.
• 3 or more years of relevant experience required.
• Willingness to perform in vivo testing in support of product efficacy and quality.
• General quality / production experience in a cGMP regulated facility is required.
• Good interpersonal skills, good hands on, analytical, problem solving and decision-making skills.
• Excellent writing and verbal communications skills
• Close attention to detail required.
• Good computer skills, including utilizing personal computers and data entry programs.
• Ability to work independently and with others to accomplish goals and priorities.
• Flexibility and teamwork skills.
• High level of energy and regular, consistent attendance.

LSNJN-CR_1712681116
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