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Lab Associate

3 months ago

Marion, United States IMS People Full time $26
Job DescriptionJob Description

Job description for your reference,
Title: Quality Lab Associate I- EM – Water Sampling/Investigations Protocol Support (Contractor)
Location: Marion (North Cove), NC. ONSITE.
Duration: 6 months with the possibility of extension/conversion

Your Role

  • 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.


Your Team

  • Within Quality, every role makes a difference. Products that client makes are shipped worldwide for patients in need.
  • 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.
  • The mission of client is to save and sustain lives. 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.

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 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

Experience
• 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