Quality Lab Associate I

Southern Arkansas University; Marion (NC); On-site; USD 40,000 - 70,000; Full time

Job description

Job Title: Quality Lab Associate I
Duration: 6+ Months (Possible extensions)
Location: Marion, NC 28752

About the Role:
This position supports the environmental monitoring program by performing essential testing, including water sampling, surface testing, viable air monitoring, and air total particle counts. The role is also responsible for routine risk assessments and HEPA filter inspections in clean-room environments.

Key Responsibilities:

• Collect environmental monitoring samples throughout the facility following Standard Operating Procedures on a defined schedule.
• Collect water samples daily, weekly, and monthly from various locations within the facility.
• Process water samples to test for Microbial Total Count and Coliform levels.
• Perform weekly Real Time Risk Assessments (RTRA) to identify potential contamination risks in clean rooms.
• Review Environmental Events/Deviations to ensure documentation and testing are complete before submission for approval.
• Collaborate with Quality Operations, Manufacturing, and Engineering teams to initiate corrective actions and work orders as needed.
• Lead investigations of microbial out-of-limit incidents, determining root causes and implementing corrective or preventive actions to prevent recurrence.
• Work cross-functionally with teams in Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate handling of scope, product impact, root causes, and CAPAs (Corrective and Preventive Actions).
• Provide timely updates on investigation status and foster collaboration to ensure high-quality, timely investigations and corrective actions.
• Close investigations promptly to meet business and compliance needs.
• Manage multiple investigations simultaneously with minimal supervision.
• Ensure testing is completed within required timeframes.
• Coordinate validation protocols with Technical Services and the Microbiology Group.
• Maintain a clean and safe work environment, adhering to 6S principles.

Required Qualifications:

• Bachelor’s degree in Microbiology, Biology, or a related science field.
• 0-2 years of experience, with at least 1 year of experience in the pharmaceutical or medical device industry preferred.
• Experience in root cause investigations within the pharmaceutical or medical products industry is preferred.
• Strong communication and project management skills.
• Knowledge of core manufacturing and support systems.
• Proficient in Microsoft Office applications (Word, Excel).
• Ability to work effectively in a team environment with strong interpersonal skills.
• Proficient in aseptic handling and use of media plates and swabs for environmental monitoring sampling.
• Self-motivated with minimal supervision required.
• Strong attention to detail and organizational skills.
• Basic understanding of laboratory instrumentation.
• Good documentation skills and knowledge of Good Documentation Practices (GDP).
• Ability to manage multiple tasks and priorities effectively.
• Knowledge of aseptic techniques and microbiological testing according to FDA, cGMP, GLP, and USP methodologies.
• Familiarity with LIMS (Laboratory Information Management System) and TrackWise.
• Strong communication skills, with the ability to engage effectively with supervisors and peers.
• Knowledge of FDA quality system regulations is preferred.