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Quality Lab Associate I

1 month ago

Marion, United States IMS People Full time
Job DescriptionJob Description

Job Title: Quality Lab Associate I
Location: Marion NC USA 28752
Duration: 06 Months
 
Description:
 
Quality Lab Associate I- EM – Water Sampling/Investigations Protocol Support (Contractor)

This is where you save and sustain lives
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

This is where your creativity addresses challenges
Supports the environmental monitoring program by performing testing such as water testing, surface testing, viable air monitoring, and air total particle counts. Responsible for conducting routine risk assessments and HEPA filter inspections in clean-rooms.

Within Quality, every role makes a difference. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

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.
 

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