Overview In this role you will manage environmental monitoring programs and QC activities in a GMP microbiology lab. You will perform water, air, and surface testing, maintain lab documentation, and support qualification and validation efforts. You'll work to ensure regulatory compliance and data integrity while collaborating with QA and cross-functional teams. This is a hands-on opportunity to impact product quality and compliance within a regulated manufacturing environment.
Compensation / Benefits- competitive pay
- annual performance bonus
- medical/dental/vision coverage
- 401(k) with employer contribution
- paid vacation
- personal and sick days
Responsibilities- Perform environmental monitoring procedures (water, viable/non-viable air, viable surface)
- Maintain microbiology lab equipment and temperature monitoring (incubators, storage refrigerators)
- Test vendor approvals and media qualification for the microbiology lab
- Support cleaning verification with Total Organic Carbon testing
- Trend microbiology data and report to management and QA
- Perform endotoxin testing (kinetic and gel clot methods) for final products
- Write/revise GMP documentation and SOPs
- Ensure GMP area cleanliness and organization for material control
- Operate and calibrate lab equipment (chart recorders, thermometers, balances, pipettes)
- Investigate deviations/OOS as instructed by supervisor
- Follow safety guidelines for chemical and bacterial waste
- Plan, organize, and prioritize multiple tasks in a cross-functional setting
- Communicate findings clearly to technical and non-technical audiences
- Proficient use of Microsoft Office; familiarity with electronic quality systems (TrackWise, MasterControl)
- Willingness to work flexible hours including occasional night shifts and weekends
Key requirements- Bachelor's degree in chemistry, microbiology or related field; Master's preferred
- Minimum 3 years' experience in pharmaceutical/biotech or life sciences
- Hands-on experience with TOC, LAL endotoxin, conductivity, bioburden, MALDI-TOF
- Proficiency in EM, cleanroom qualification, data trending (MODA, LIMS or equivalent)
- Strong knowledge of ICH guidelines (Q1, Q5, Q7, Q9, Q10) and USP/FD&A EMA expectations
- Experience in ISO 7/ISO 8 cleanrooms and aseptic processing
- Familiarity with CAPA, root cause analysis tools, and risk management
- Excellent documentation practices and data integrity (ALCOA+)
- Strong planning, organizational, and communication skills
- Proficiency in Microsoft Office; experience with electronic QMS (TrackWise, MasterControl)
- strong communication
- attention to detail
- cross-functional collaboration
- Total Organic Carbon (TOC)
- Endotoxin LAL testing
- Conductivity
