Job Description
Job Description
QC Microbiologist I / Scientist IPosition Summary
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.
Key Responsibilities
- 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.
Required Qualifications
- 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.
Preferred Qualifications
- 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.
Key Competencies
- 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
What You'll Gain
- 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.
Job Type & Location
This is a Contract to Hire position based out of Saint