• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Author, revise, review and approve site procedures and policies related to Environmental Monitoring and Sterility as applicable.
• Author quality control EM data trend charts and reports.
• Serve as backup in the absence of microbiology supervisor/management
• Employ aseptic techniques in the performance of testing per USP and Curium Standard Operating Procedures (SOP) and Standard Test Methods (STM) for Sterility, Endotoxin, Bioburden on drug products, intermediates and raw materials.
• Train new employees in microbiological and aseptic techniques and serve as mentor for new and junior employees.
• Perform Growth Promotion testing, Bioburden, and/or sterility testing
• Prepare and analyze Biological Indicators in support of various Validation and Qualification activities.
• Read plates to quantify microbial growth and subculture pure isolates as required.
• General laboratory housekeeping duties.
• Assist with laboratory investigations including OOS, 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.

• Bachelor Degree required (Microbiology, Biology, Cellualar Bigology). 
• Five or more years of Environmental Monitoring and Sterility experience
• Experience with endotoxin and bioburden on drug products, intermediates and raw materials.
• Experience with aseptic process simulations.
• Quality and production experience in a cGMP / FDA regulated facility is required.

#IND-SPG



Estimated Min Rate : $80000.00

Estimated Max Rate : $94000.00

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.