Senior Specialist QA - I

WorkLlama, Inc.; Durham (NC); On-site; USD 52,000 - 75,000; Full time

Job summary

WorkLlama, Inc. is seeking an Associate Specialist in Quality Control to join a global biopharmaceutical supply network. You will assist in microbiological, chemical, and analytical sampling and work with Production, QA, Validation, and Facilities teams to ensure product quality.

The role emphasizes environmental monitoring, release testing, and cross-functional collaboration, with a first-shift schedule and multiple weekly options offered.

Qualifications

• GLP and cGMPs knowledge required
• Experience with environmental monitoring and testing
• Aseptic technique proficiency
• Strong written and verbal communication

Responsibilities

• Conduct environmental monitoring sampling, including active air, surface, and water.
• Perform release testing for finished products, including sterility testing and moisture detection.
• Execute microbiological testing and evaluate environmental samples.
• In-process environmental monitoring testing in support of manufacturing operations.
• Evaluate laboratory data, troubleshoot, and contribute to report writing and interdepartmental committees.
• Identify and resolve technical or operational shop-floor problems under guidance from department heads while adhering to established policies and procedures.
• Interact cross-functionally with internal departments and external resources to maintain seamless manufacturing support.

Skills

GLP & cGMPs

Aseptic technique

Lab data analysis

Communication skills

LIMS/SAP familiarity

Education

Associate's degree in Biology/Microbiology

Bachelor's degree in Biology/Microbiology

Tools

LIMS

SAP

Job description

Summary Join a globally trusted manufacturing network dedicated to delivering high-quality, reliable biopharmaceutical supplies to patients worldwide. As an Associate Specialist in Quality Control, you will join a Quality group that ensures every material inside our products meets stringent regulatory standards and quality requirements. Working in a collaborative team environment, you will assist in product quality assurance by conducting microbiological, chemical, and analytical sampling, while partnering closely with Production, Quality Assurance, Validation, and Facilities teams.

Responsibilities

• Conduct environmental monitoring sampling, including active air, surface, and water sampling across facilities.
• Perform release testing for finished products, including sterility testing, residual moisture detection, and average cell dry weight testing.
• Execute microbiological testing and evaluate environmental microbiological samples.
• Conduct in-process and routine environmental monitoring testing in support of manufacturing operations.
• Evaluate laboratory data, conduct troubleshooting, participate in process improvements, and contribute to report writing and interdepartmental committees.
• Identify and resolve technical or operational shop-floor problems under guidance from department heads while adhering to established policies and procedures.
• Interact cross-functionally with internal departments and external resources to maintain seamless manufacturing support.

Education

• Associate's or Bachelor's degree in Biology, Microbiology, Biochemistry, or a related scientific field.

Experience

• Associate's degree holders require 1-2 years of relevant laboratory or pharmaceutical experience (Bachelor's degree requires equivalent academic/foundational background).
• Demonstrated understanding and application of Good Laboratory Practices (GLP) and cGMPs.
• Hands-on proficiency in aseptic technique and performance of environmental and water systems monitoring.
• Strong written and verbal communication skills, with preferred experience using LIMS, SAP, or other laboratory/production software systems.

Additional Information

• Position Type & Quantity: 2 openings available.
• Shift Structure: 1st Shift Days (8:30 AM - 5:00 PM with flexibility for earlier or later start times based on environmental monitoring needs). Includes an 8-hour shift with a 30-minute lunch break.
• Weekend Work Required: Schedules available are Sunday - Thursday OR Tuesday - Saturday.