Quality Technician II
Job Location:
Job Location:
Durham, NC - USA
Monthly Salary:
Not Disclosed
Monthly Salary:
Posted on:
Yesterday
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Department:
Job Summary
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.
- 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
- Bachelors degree in Biology Microbiology Chemistry or a related scientific field required
Required Experience:
IC
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