The purpose of this position is to perform standard laboratory testing and routine experiments using established procedures and related scientific principles. Testing activities may support product release, equipment qualification and validation, change control, CAPAs, deviations, process improvements, product transfers, and other site initiatives. The role is responsible for preparing reports and assisting with technical problem resolution as needed.
This position works on moderately complex assignments requiring sound judgment and routine decision making. Standard tasks are performed independently, while new assignments are completed under general guidance. The role regularly collaborates with manufacturing, sterilization, vendors, contract laboratories, and other company sites.
Key Responsibilities
Environmental Monitoring
Conduct routine monitoring of water, air, and surface quality to identify and mitigate contamination risks.
Quality Control Testing
Perform laboratory testing of components and finished products according to established schedules and procedures.
Review and document test data to ensure results meet required specifications.
Perform TOC, Gram staining, growth promotion, particulate count, bioburden, sterility, endotoxin, cell-based assays, and other biological and chemical testing.
Complete investigations and corrective actions as needed while maintaining accuracy and compliance.
Sample Management
Manage sample distribution processes with accurate tracking and documentation.
Inventory Management
Monitor laboratory supply and reagent inventory, including ordering and restocking as necessary.
Data Entry & Documentation
Accurately enter laboratory results, observations, and activities into data management systems in a timely manner.
Laboratory Maintenance
Maintain laboratory cleanliness and organization through routine cleaning, autoclaving, and glassware washing.
Validation & Qualification Activities
Support assay validations, equipment qualifications, and special projects under general supervision.
Process Improvement
Assist with implementing and revising standard operating procedures.
Identify workflow inefficiencies and recommend process improvements.
Team Collaboration
Work closely with Laboratory Leadership to address technical issues, recommend solutions, and anticipate operational challenges.
Coordinate laboratory testing assignments and workflow as needed.
Train new personnel according to established procedures.
Perform additional duties as assigned.
Job Requirements
2 to 3 years of laboratory experience required
Pharmaceutical and investigation experience strongly preferred
Experience performing microbiological and chemistry-based testing
Familiarity with laboratory documentation and quality systems
Strong attention to detail and organizational skills
Ability to work independently and manage multiple priorities
Education
Bachelor's degree in Biology, Microbiology, Chemistry, or a related scientific field required