Quality Technician II

Job Title: Quality Technician II

Location: Durham, NC 27712

Bill Rate: 34.43

Duration: 365 days

Note: -2–3 years of experience required. Please ensure that all submitted candidates have investigation experince in in pharma environment.

Summary Of Job

The purpose of this position is to conduct standard laboratory tests and routine experiments requiring the use of well-established procedures, with some understanding of related principles. These tests may be in support of product release, equipment qualification or validation, change control, CAPAs, deviations, process improvements, product transfers or other site initiatives. Prepares reports and recommends solutions to technical problems as required. Works on assignments that are moderately complex in nature where judgment is required in resolving problem and making routine decisions. Standard work is conducted with no supervision; new assignments are conducted with general instructions. This position interacts with all functional groups within manufacturing and sterilization, and with other CLS sites, vendors and contract test laboratories.

Must-have/Required Skills

• 2-3 years of experience
• Pharma/investigation experience
• Bachelor’s degree in Biology, Microbiology, Chemistry, or related field
• Environmental Monitoring experience
• Quality Control Testing experience
• Experience performing TOC, Gram staining, Growth promotion, Particulate count, bioburden, sterility, endotoxin testing, cell-based assays, and other biological and chemistry testing
• Sample Management experience
• Inventory Management experience
• Data Entry and Record-Keeping skills
• Laboratory Maintenance experience
• Ability to perform assay validations and equipment qualifications
• Ability to implement and revise standard operating procedures
• Ability to identify workflow or procedure inefficiencies and propose solutions
• Ability to coordinate laboratory testing assignments and duties
• Ability to train new personnel as per established procedures
  
  

Nice-to-have Skills

• Experience supporting product release, equipment qualification or validation, change control, CAPAs, deviations, process improvements, and product transfers
• Experience interacting with manufacturing and sterilization teams, vendors, and contract test laboratories
  
  

Key Responsibilities And Duties

• Conduct routine assessments of water, air, and surface quality to identify and mitigate potential contamination risks
• Perform specified testing of components and finished goods submitted to the laboratory for analysis in a timely manner following the required testing schedule
• Review test data to ensure results meet all specifications and input data
• Perform TOC, Gram staining, Growth promotion, Particulate count, bioburden, sterility, endotoxin testing, cell-based assays and other biological and chemistry testing to verify compliance with quality standards
• Complete investigations and corrective actions as deemed necessary
• Manage the sample distribution process, ensuring meticulous tracking and documentation throughout the process
• Oversee the inventory of laboratory supplies and reagents, including ordering and restocking to support testing activities
• Enter test results, observations, and laboratory activities into data management systems accurately and in a timely manner
• Maintain cleanliness and organization in laboratory spaces through routine cleaning procedures, including autoclaving and glassware washing
• Perform assay validations, equipment qualifications or special assignments under general supervision
• Implement and revise standard operating procedures
• Identify areas of workflow or procedure inefficiencies and propose solutions to increase efficiency
• Work closely with the Laboratory Supervisor to review technical problems, suggest solutions and anticipate major problems to key operations
• Use discretion to direct workflow by coordinating laboratory testing assignments and duties
• Train new personnel as per established procedures
• Perform other tasks as assigned