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Microbial Testing Specialist

2 months ago

Indianapolis, Indiana, United States Randstad Life Sciences US Full time

Job Title: Quality Lab Associate I

Duration: 6 Months

Location: Marion, NC

Max PR: $25.21/hr

Role Overview

As a key player in our Quality team, you will engage in vital environmental monitoring activities, ensuring the integrity of our processes and products. Your contributions will be instrumental in maintaining the high standards that our organization is known for.

Key Responsibilities

  • Conduct environmental monitoring by collecting samples across various locations in the facility in accordance with established protocols.
  • Perform routine water sampling on a defined schedule to ensure compliance with quality standards.
  • Process and analyze water samples for microbial testing, including Total Count and Coliform assessments.
  • Utilize ladders and scaffolding safely to facilitate water sampling.
  • Execute weekly Real Time Risk Assessments (RTRA) to proactively identify contamination risks in controlled environments.
  • Review and validate Environmental Events/Deviations documentation to ensure completeness prior to submission for approval.
  • Collaborate with Quality Operations, Manufacturing, and Engineering teams to address identified issues and implement corrective actions.
  • Lead investigations into microbial deviations, determining root causes and establishing effective corrective and preventive measures.
  • Work closely with cross-functional teams to ensure timely resolution of issues impacting product quality.
  • Maintain open communication with staff at all levels regarding investigation progress and outcomes.
  • Foster a collaborative environment focused on quality improvement and timely resolution of issues.
  • Ensure investigations are completed promptly to meet both business and compliance requirements.
  • Manage multiple investigations simultaneously while adhering to strict timelines.
  • Coordinate validation protocols with Technical Services and Microbiology teams.
  • Uphold a clean and safe work environment by applying 6S principles.

Qualifications

  • B.S. degree in Microbiology, Biology, or a related scientific discipline.
  • 0-2 years of relevant experience; at least 1 year in the Pharmaceutical or Medical Device sector is preferred.
  • Experience in conducting root cause analyses within the pharmaceutical or medical products industry is advantageous.
  • Strong communication and project management abilities.
  • Proficient in Microsoft Office applications (Word, Excel).
  • Excellent interpersonal skills with the ability to work effectively in a team-oriented environment.
  • Knowledgeable in aseptic techniques and microbiological sampling methods.
  • Detail-oriented with strong organizational capabilities.
  • Familiarity with laboratory instrumentation and Good Documentation Practices (GDPs).
  • Able to prioritize and manage multiple tasks efficiently.
  • Understanding of FDA, cGMP, GLPs, and USP testing methodologies.
  • Experience with LIMS or similar systems is a plus.
  • Knowledge of FDA quality system regulations is preferred.