GMP Microbiology Associate II - Quality & Compliance

RXinsider LTD.; Irvine, Northern (CA, KY); Hybrid; USD 34,000 - 45,000; Full time

Job summary

B. Braun Medical Inc. is seeking a Microbiology II professional to support routine microbiological testing and monitoring in a GMP-regulated manufacturing environment. This on-site role collaborates with Quality, Manufacturing and Laboratory teams to ensure data integrity and regulatory compliance.

The position requires a High School Diploma (or equivalent) with a Bachelor's in Microbiology preferred, plus experience in regulated labs. Training on ALCOA, GDP and LIMS is provided.

Qualifications

• High School Diploma or equivalent required.
• Bachelor's degree in Microbiology or related field preferred with 1–2 years of related lab experience.
• Experience in GMP/GLP/pharmaceutical/regulated environments.
• Knowledge of aseptic laboratory practices and microbiological testing methods.
• Experience with LIMS or electronic laboratory systems.

Responsibilities

• Perform routine microbiological testing and monitoring of raw materials, finished products, stability samples, and related laboratory programs.
• Utilize aseptic techniques during microbiological testing and analysis.
• Collect, analyze, and document microbiological data to support product quality and regulatory compliance.
• Maintain laboratory records, logbooks, data sheets, and LIMS entries per ALCOA, GDP, and data integrity requirements.
• Assist in preparation of media, reagents, testing materials, and equipment.
• Participate in investigations, non-routine testing, and continuous improvement activities.
• Ensure compliance with cGMPs, GLPs, SOPs, USP standards, and FDA regulations.

Skills

Written/verbal communication

Organizational skills

Attention to detail

Data management

Microsoft Office

Education

High School Diploma or equivalent

Bachelor's degree in Microbiology or related

Tools

LIMS

Microsoft Excel

Electronic lab systems

Job description

B. Braun Medical Inc. is seeking a Microbiology II professional to support routine microbiological testing and monitoring in a GMP-regulated manufacturing environment. This on-site role collaborates with Quality, Manufacturing and Laboratory teams to ensure data integrity and regulatory compliance.

The position requires a High School Diploma (or equivalent) with a Bachelor's in Microbiology preferred, plus experience in regulated labs. Training on ALCOA, GDP and LIMS is provided.