Quality Control Analyst

3 days ago

Durham NC, United States Pacer Group Full time

Associate Specialist, QC Duration: 23 Months
Shift: Monday – Friday 10:00 AM to 6:00 PM EST

Education/Experience Requirements
• Associate's degree in Biology, Microbiology, Biochemistry, or related field plus 1-2 years of relevant laboratory/pharmaceutical experience
• Bachelor's degree in Biology, Microbiology, Biochemistry, or related field

Understanding and application of Good Laboratory Practices and cGMPs
• Performance of environmental and water systems monitoring
• Experience with LIMS, SAP or other laboratory/production software systems

Reports to Quality Control manager
• Our Quality group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The main function of the Associate Specialist, Quality Control is to assist in the assurance of the quality of product through the performance of microbiological, chemical and analytical sampling and assays as well as interacting with Production, Quality Assurance, Validation and Facilities, and external resources, as necessary to support Manufacturing.

Conducts release testing in support of finished product
• Conducts microbiological testing; evaluation of environmental microbiological samples
• Conducts environmental monitoring sampling to include active air and surface sampling and water sampling
• Evaluates data, conducts trouble shooting, process improvements, report writing, involvement in interdepartmental committees and projects
• Maintains lab materials and reagents
Conducting In-Process and Release testing
• Conducting Environmental Monitoring of processes and on a routine basis

o Accountable for own performance

o Makes decisions – guided by policies and procedures – on the shop floor
o Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes

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