QUALITY LAB ASSOCIATE I - DivIHN Integration : Job Details

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: Meenakshi at 630 ### #### Hema at 630 ### ####

Title: Quality Lab Associate I Location: Marion, NC Duration: 6 Months

Job Description :

• This is where you save and sustain lives
• At Client, we are deeply connected by our mission.
• No matter your role at Client, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
• Client's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
• 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.

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 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.

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.

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.