The QC Microbiologist I / Scientist I supports microbiological testing activities in a cGMP-compliant Quality Control laboratory responsible for the manufacture and release of biological products. This role performs routine microbiological testing, supports validation activities, maintains laboratory documentation, and collaborates with cross-functional teams to ensure quality and regulatory compliance. The ideal candidate has hands-on microbiology laboratory experience, strong attention to detail, and an interest in developing expertise within a regulated pharmaceutical or biotechnology environment.

• Perform microbiological testing on water, in-process, environmental, and product samples in accordance with approved procedures.
• Conduct bioburden testing, bacterial endotoxin testing (BET), growth promotion testing, biological indicator testing, and maintenance of stock cultures.
• Support microbiological method validation and qualification activities.
• Collect, analyze, document, and communicate experimental data, observations, and test results accurately and in compliance with cGMP requirements.
• Prepare and maintain laboratory documentation, including test records, logbooks, protocols, reports, and controlled documents.
• Assist with investigations related to out-of-specification (OOS), out-of-trend (OOT), and other laboratory events, including root cause analysis and corrective actions.
• Utilize aseptic techniques and established microbiological methods to ensure reliable and accurate results.
• Apply microbiological techniques including culturing, plating, gram staining, light microscopy, microbial identification, and taxonomy.
• Coordinate sample receipt, handling, tracking, and disposition activities to ensure timely completion of testing.
• Manage laboratory inventory and order supplies in accordance with departmental procedures.
• Maintain laboratory equipment, workspaces, and records in a state of inspection readiness.
• Collaborate with Quality, Manufacturing, Validation, and other cross-functional teams to support product release and manufacturing operations.
• Adhere to all laboratory safety, environmental, and quality requirements.

• Bachelor's degree in Microbiology, Biology, Life Sciences, or a related scientific discipline.
• Minimum of 6 months of microbiology laboratory experience gained through industry, internships, research projects, academic laboratories, or equivalent experience.
• Hands-on experience with aseptic technique and basic microbiological testing methods.
• Experience with laboratory sample preparation, handling, documentation, and data collection.
• Familiarity with microbiological techniques such as culturing, plating, gram staining, microscopy, and microbial identification.
• Strong attention to detail and commitment to data integrity and quality.
• Effective written and verbal communication skills.
• Ability to work effectively both independently and within a team environment.
• Strong organizational and time-management skills with the ability to manage multiple priorities.

• Experience working in a cGMP, GLP, pharmaceutical, biotechnology, medical device, food, or related regulated environment.
• Experience performing bioburden testing, bacterial endotoxin testing (BET), growth promotion testing, environmental monitoring, sterility assurance, or microbial identification testing.
• Familiarity with laboratory quality systems and electronic systems such as LIMS, TrackWise, Documentum, or equivalent platforms.
• Experience supporting investigations, deviations, OOS/OOT events, or CAPA activities.
• Experience drafting or revising SOPs, protocols, reports, and laboratory documentation.
• Knowledge of biologics, pharmaceutical manufacturing, or quality control laboratory operations.

• Microbiology Laboratory Operations
• Aseptic Technique
• Quality Control Testing
• Data Collection & Analysis
• Documentation & Compliance
• Problem Solving
• Attention to Detail
• Collaboration & Teamwork
• Adaptability
• Technical Communication
• cGMP & Quality Systems

• This role provides an excellent opportunity for early-career scientists to develop expertise in GMP microbiology, biological product testing, validation activities, quality systems, and pharmaceutical manufacturing while working alongside experienced microbiology professionals in a highly regulated environment.

This is a Contract to Hire position based out of Saint