Quality Lab Associate Entry level Science Graduates

2 weeks ago

Marion, United States ML OUTSOURCING SERVICES PRIVATE LIMITED Full time

Job Title: Quality Lab Associate

Job Location: Marion, NC

Duration: 12+ months


Entry level college grads will be considered


Job Description:

What you'll be doing

• 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 prior to submitting for approval

• Develops 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 in a timely manner to meet business and compliance needs

• Works with minimal supervision to drive investigations to closure

• Manages several investigations at a time

• Complete testing within required timeframes

• Validation Protocol coordination with the Technical Services and Microbiology Group

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

What you'll bring

• 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 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 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

• Able to communicate optimally with supervisors and peers

• Knowledge of FDA quality system regulations is preferred

We understand compensation is an important factor as you consider the next step in your career. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Other Duties as Assigned

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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