Job Description

Job Title: Microbiologist II

Location: Charlotte, North Carolina

Salary: $35 p/hour

Overview

A global company specializing in biotechnology and medical devices is hiring a skilled Microbiologist II to join the team and oversee the Microbiology Department functions and activities. The ideal candidate will be responsible for performing microbiological testing and examination, executing method validations, and assisting in developing and implementing processes to ensure effective contamination control strategies.

Responsibilities

• Perform microbiological testing and examination according to valid procedures.
• Execute method validations for medical devices and non-medical devices for bioburden and sterilization.
• Assist in the development and implementation of processes and facility monitoring.
• Act as a subject matter expert for method validation for new products.
• Author SOPs, and test procedures, and assist in creating validation protocols and reports for the lab.
• Data entry for trends and reporting for management review.
• Interpret sterilization dose audit results and elevate data trends as needed.
• Test non-conforming products to resolve issues and investigate returned products.
• Assist in investigations and completion of assigned CAPA as needed.
• Conduct aseptic technique training and hygiene regulation training for other departments.
• Review and maintain stock of consumables for the Microbiology department.
• Coordinate sample testing via external/third-party vendors.
• Communicate and exchange information with affiliated facilities.

Qualifications

• Minimum Bachelor’s or Master’s Degree in microbiology or related field.
• Minimum 3 years of relevant work experience in a GMP-controlled laboratory environment.
• Experience in Medical devices, pharmaceuticals, and/or regulated industries is preferred.
• Basic knowledge of medical device regulation, industry, and international standards.
• Basic understanding of computer systems (Word, Excel, Outlook, and instrument dedicated).
• Knowledge of gamma and E-beam sterilization, and ISO 11137 requirements.

Day-to-Day

The Microbiologist II will be responsible for performing microbiological testing, executing method validations, authoring SOPs, conducting training, and coordinating sample testing. They will also be involved in data entry, trend analysis, and communication with affiliated facilities.

Benefits

• Competitive salary
• Health, dental, and vision insurance
• Retirement savings plan
• Paid time off and holidays
• Professional development opportunities

Click apply or speak to Mark Ainscough for the full details at mainscough@kensingtonadditive.com

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