Position Overview:

We are seeking a highly motivated and detail-oriented Quality Control Microbiologist with experience in Quality Control (QC) environment within CGMP pharmaceutical, biotechnology, or environmental laboratory settings. The ideal candidate will have a strong foundation in Microbiology Testing, specifically in Environmental Samples (surface and air), Purified Water Samples, and Microbial Limit Testing following USP guidelines. Additionally, the candidate should possess a solid understanding of analytical techniques such as ELISA, HPLC, GC, Flow Cytometry, UV-Vis, and others.

Key Responsibilities:

• Perform routine quality control testing of raw materials, in-process materials, finished products, and environmental samples in accordance with CGMP (Current Good Manufacturing Practice) guidelines.
• Conduct microbiological testing on Environmental Samples, including surface and air samples, Purified Water Samples, and perform Microbial Limit Testing for raw materials and finished products as per USP standards.
• Perform and interpret tests using analytical techniques such as HPLC, GC, Flow Cytometry, UV-Vis, and other general techniques as required.
• Ensure compliance with CGMP, FDA regulations, and other regulatory standards in all aspects of QC testing.
• Assist in writing and revising Standard Operating Procedures (SOPs), reports, and protocols related to QC testing and procedures.

Qualifications:

• Bachelor’s Degree in Chemistry, Microbiology, or a related scientific field.
• Minimum of 1 years of progressive experience in a Quality Control environment within CGMP pharmaceutical, biotechnology, or environmental laboratories.
• Hands-on experience with microbiology testing for Environmental Samples, including surface, air, and Purified Water Samples.
• Familiarity with Microbial Limit Testing, ELISA, Flow Cytometry, Gram Staining and USP guidelines.
• Solid understanding of analytical chemistry principles with direct experience in HPLC, GC, FTIR, UV-Vis, and other general analytical techniques.
• Strong knowledge of CGMP and regulatory compliance in a pharmaceutical or biotechnology setting.
• Experience working with automated laboratory systems and laboratory data management software.