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Quality Assurance Laboratory Associate I

2 months ago

Marion, North Carolina, United States Adecco USA Full time

Adecco is currently supporting a prominent American healthcare organization in the search for a Quality Lab Associate in the Marion area.

Work Schedule: 40 hours per week

Compensation: The hourly wage for this role is $25.50, which may vary based on experience, education, geographic location, and other relevant factors.

This position plays a crucial role in the environmental monitoring program by conducting various tests, including water analysis, surface assessments, viable air monitoring, and total particle counts in the air. The associate will be responsible for performing routine risk evaluations and HEPA filter inspections within controlled environments.

Key Responsibilities:

  • Collect environmental monitoring samples throughout the facility according to established Standard Operating Procedures on a scheduled basis.
  • Gather water samples from various locations within the facility on a daily, weekly, or monthly basis.
  • Process water samples to test for Microbial Total Count and Coliform.
  • Utilize ladders or scaffolding as necessary for water sampling tasks.
  • Conduct weekly Real Time Risk Assessments (RTRA) to identify potential contamination risks in controlled environments.
  • Review Environmental Events/Deviations to ensure thorough documentation and testing prior to approval submission.
  • Collaborate with Quality Operations, Manufacturing, and Engineering teams to initiate corrective actions and work orders when issues arise.
  • Lead investigations into microbial out-of-limit occurrences, determining root causes and defining effective corrective and preventive measures.
  • Engage with Quality, Operations, Engineering, Maintenance, and Supply Chain teams to ensure timely and accurate determination of scope, product impact, root cause, and CAPAs.
  • Communicate effectively with all levels of staff, providing updates on investigation progress.
  • Foster collaborative relationships focused on high-quality investigations, effective corrective actions, and minimizing out-of-limit occurrences.
  • Ensure timely closure of investigations to meet business and compliance requirements.
  • Work independently to drive investigations to completion.
  • Manage multiple investigations simultaneously.
  • Complete testing within designated timeframes.
  • Coordinate Validation Protocols with Technical Services and Microbiology Groups.
  • Maintain a clean and safe work environment by applying 6S principles.

Qualifications:

  • B.S. degree in Microbiology, Biology, or a related scientific field.
  • 0-2 years of relevant experience; at least 1 year in the Pharmaceutical or Medical Device industry is preferred.
  • Experience in conducting root cause investigations within the pharmaceutical or medical products sector is advantageous.
  • Strong communication and project management skills are essential.
  • Knowledge of core manufacturing and support systems is required.
  • Proficiency in Microsoft Office applications (Word, Excel) is necessary.
  • Excellent interpersonal skills and the ability to work effectively in a team-oriented environment.
  • Experience in aseptic handling of media plates and swabs for environmental monitoring sampling.
  • Self-motivated individual who requires minimal supervision.
  • Attention to detail and strong organizational capabilities are crucial.
  • Basic understanding of laboratory instrumentation is necessary.
  • Good documentation skills and familiarity with Good Documentation Practices (GDPs).
  • Able to manage multiple tasks and priorities efficiently.
  • Knowledge of aseptic techniques and microbiological testing in accordance with FDA, cGMP, GLPs, and USP methodologies.
  • Familiarity with LIMS or equivalent systems and TrackWise is preferred.
  • Effective communication skills with supervisors and peers are essential.
  • Understanding of FDA quality system regulations is a plus.

Benefits: Adecco offers a comprehensive benefits package that includes medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an Employee Assistance Program (EAP), commuter benefits, and a 401K plan. Our benefits allow employees to select coverage that meets their individual needs. Paid leave options may include Paid Sick Leave as required by law, along with any other paid leave mandated by Federal, State, or local regulations, as well as holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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