Quality Lab Associate

3 weeks ago

Marion, United States Rose International Full time

The client seeks a candidate to support their environmental monitoring program in a cleanroom or pharmaceutical/medical device setting. The role involves conducting environmental and water testing, risk assessments, and leading investigations into contamination issues. The candidate will collaborate with cross-functional teams, ensure compliance with FDA/cGMP standards, and manage corrective actions. Strong documentation, project management, and aseptic technique skills are essential, as well as knowledge of industry regulations. Familiarity with LIMS and TrackWise is preferred.

Must-Have:

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)

Must have good interpersonal skills and be able 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

Must be a dedicated individual who requires minimal direction

Attention to detail and strong organizational skills

Must have a 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

Able to communicate optimally with supervisors and peers

Knowledge of FDA quality system regulations is preferred

Job 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

Be able to climb ladders/scaffolding for water sampling purposes

Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in clean rooms

Reviews 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

Leads 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

Partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause, and CAPAs

Interacts with all levels of staff and provides timely updates on investigation status

Fosters collaborative relationships focused on high-quality and timely investigations, effective corrective actions, and the reduction of out-of-limit generation rate

Closes investigations promptly to meet business and compliance needs

Works with minimal supervision to drive investigations to closure

Manages several investigations at a time

Complete testing within the required timeframes

Validation Protocol coordination with the Technical Services and Microbiology Group

Sustain a clean and safe work environment by applying 6S principles

  • **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

  • **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

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.

California Pay Equity:

For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

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). (Posting required by OCGA 13/10-91.).

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