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Quality Technician II

Premier Staffing Solution

Durham, NC

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JOB DETAILS
SKILLS
Air Quality, Assays, Autoclave, Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Corrective Action, Data Management, Detail Oriented, Distribution Management, Documentation, Environmental Monitoring, Equipment Validation, Laboratory, Laboratory Testing, Leadership, Maintain Compliance, Manufacturing, Microbiology, Multitasking, Organizational Skills, Problem Solving Skills, Procedure Development, Process Improvement, Process Management, Product Support, Quality Control, Reporting Skills, Risk Management, Schedule Development, Scientific Principles, Specimens/Samples, Staff Training, Standard Operating Procedures (SOP), Sterilization, Test Data, Testing, Time Management, Workflow Analysis
LOCATION
Durham, NC
POSTED
30+ days ago
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

  • Bachelor's degree in Biology, Microbiology, Chemistry, or a related scientific field required

About the Company

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