Quality Assurance Specialist

6 days ago

Marion, North Carolina, United States Rose International Full time
Job Summary

We are seeking a highly skilled Quality Lab Associate to support our environmental monitoring program in a cleanroom or pharmaceutical/medical device setting. The ideal candidate will have a strong background in microbiology and experience in conducting environmental and water testing, risk assessments, and leading investigations into contamination issues.

Key Responsibilities
  • Collect environmental monitoring samples throughout the facility following Standard Operating Procedures on a defined frequency
  • Collect water samples throughout the facility on a daily/weekly/monthly basis
  • Process water samples for testing of Microbial Total Count and Coliform
  • Perform weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in clean rooms
  • Review Environmental Events/Deviations to ensure documentation and testing is complete before submitting for approval
  • Develop joint relationships with Quality Operations/ Manufacturing/Engineering to initiate corrective actions/work orders when issues are identified on the floor
  • Lead the investigation of microbial out-of-limits that occur in operations and is responsible for conducting the investigation, determining root cause, and defining effective corrective and/or preventive actions to prevent recurrence
  • Partner with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause, and CAPAs
  • Interact with all levels of staff and provide timely updates on investigation status
  • Closure of investigations promptly to meet business and compliance needs
  • Manage several investigations at a time
  • Complete testing within the required timeframes
  • Validation Protocol coordination with the Technical Services and Microbiology Group
Requirements
  • B.S. degree in Microbiology, Biology, or related science
  • 0-2 years of experience; minimum 1 year experience in Pharmaceutical/Medical Device industry preferred
  • Experience in conducting root cause investigations in the pharmaceutical/medical products industry preferred
  • Strong communication and project management skills
  • Possess knowledge of core manufacturing and support systems
  • Computer literate/knowledge of Microsoft Office applications (Word, Excel)
  • Good interpersonal skills and ability to work optimally and efficiently in a team-based environment
  • Proficient in the aseptic use and handling of media plates and swabs for EM sampling
  • Basic understanding of laboratory instrumentation
  • Good documentation skills and knowledge of GDPs (Good Documentation Practices)
  • Able to manage multiple tasks/priorities promptly
  • Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs, and USP testing methodology
  • Familiarity with LIMS (or equivalent system) and TrackWise
Benefits

For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify).

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