Quality Assurance Specialist

7 days ago


Marion, North Carolina, United States DivIHN Integration Inc Full time
Job Overview

We are seeking a highly skilled and detail-oriented Quality Lab Associate I to join our team at DivIHN Integration Inc. As a Quality Lab Associate I, you will play a critical role in ensuring the quality and safety of our products.

Key Responsibilities
  • Collect and process environmental monitoring samples throughout the facility, following Standard Operating Procedures on a defined frequency.
  • Conduct 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 prior to submitting for approval.
  • Develop and implement corrective actions/work orders in collaboration with Quality Operations, Manufacturing, and Engineering teams.
  • Investigate microbial out-of-limits issues, determine root cause, and define effective corrective and/or preventive actions to prevent recurrence.
  • Partner with Quality, Operations, Engineering, Maintenance, and Supply Chain teams to ensure timely determination of scope, product impact, root cause, and CAPAs.
Requirements
  • Bachelor's degree in Microbiology, Biology, or related science.
  • 0-2 years of experience in the Pharmaceutical/Medical Device industry, with a minimum of 1 year of experience in a related role.
  • Strong communication and project management skills.
  • Knowledge of core manufacturing and support systems.
  • Computer literate with knowledge of Microsoft Office applications (Word, Excel).
  • Ability to work optimally and efficiently in a team-based environment.
  • Proficient in aseptic use and handling of media plates and swabs for EM sampling.
  • Ability to manage multiple tasks/priorities in a timely manner.
  • Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs, and USP testing methodology.
  • Familiarity with LIMS (or equivalent system) and TrackWise.
About Us

DivIHN Integration Inc is an equal opportunity employer. We are committed to creating a diverse and inclusive work environment that values and respects all employees and applicants.



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