Job Description

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists

Rashi |

630 847 1027

Meghna |

224 369 4230

Location: Marion, NC

Duration: 6 months

The position is for water sampling and investigation support. This is a day shift Monday to Friday 8-5, 100% onsite.

Description
Your Role at Client

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.

Your Team at Client

• Within Quality, every role makes a difference.
• Products that the 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 the 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.

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
• 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 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 the required timeframes
• Validation Protocol coordination with the Technical Services and Microbiology Group
• Sustain a clean and safe work environment by 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 is 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 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

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.
• Looking for a candidate with GMP or lab experience with knowledge of aseptic techniques, investigation experience is a plus not required.
• They will help with real-time assessments and coordinate with other departments like quality operations, manufacturing, validation, etc, and the ability to collect samples (water samples), and process samples.
• This person can be a college graduate, 0-2 years exp, preferred in 1 year of experience in lab or pharma exp.(internship or college experience is also considerable)
• Good communication skills, and basic MS Office experience.
• Lifting ability up to 25 pounds.
• Tools or technology exp or knowledge not required but nice to have exp or understanding in LIMS and knowledge of MS Office, and computer software.
• Interview process- Teams call with a team and the manager- 1 round.
• Education- preferred in science/ microbiology/ biology/ chemistry/environmental/biochemistry.

About us:

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

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