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Process Manager

2 months ago

Alpharetta, United States CorDx Full time
Job DescriptionJob Description

Who is CorDx？

CorDx, a multi-national biotech organization, focused on pushing the limits of innovation and supply in global health. With over 2000 employees across the world serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drug abuse, biomarkers and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Type: Full time

Job Title: Process Manager - Chromatographic Products

Location: Onsite - Atlanta Office

Job responsibilities:

  • Responsible for production management and process optimization of chromatographic products
  • Responsible for product quality control and new product trial production
  • Responsible for product process analysis, continuous improvement and optimization of process parameters, and improvement of product quality and production efficiency
  • Standardization of product processes
  • Responsible for the development and promotion of new product processes
  • Work closely with research and development teams to innovate and improve existing products based on market demands and technological advancements
  • Collaborate with production teams to troubleshoot issues, streamline workflows, and implement best practices
  • Conduct regular audits and inspections of production facilities to monitor adherence to quality standards and identify areas for improvement
  • Investigate and resolve product quality issues, non-conformities, and customer complaints related to chromatographic products
  • Ensure compliance with regulatory requirements and standards applicable to chromatographic products, such as , FDA regulations
  • Stay informed about regulatory changes and updates that impact the production, distribution, and use of chromatographic products
  • Monitor project timelines, budgets, and resource allocation to ensure projects are completed on schedule
  • Collaborate with the Chinese team to translate internal standard operating processes and policies
  • Effectively communicate in Mandarin with the team in China to ensure smooth implementation and update the progress on a regular basis

Requirements

  • Bachelor's degree or above major in biology, chemistry or pharmacy
  • 3+ years of experience in the research and development and production process management of chromatographic products
  • Familiarity with the production process of colloidal gold and latex microspheres
  • Have the ability to analyze and solve problems
  • Proven ability to manage complex projects involving product development, manufacturing processes, and quality assurance
  • Experience in implementing and maintaining quality control procedures to ensure compliance
  • Bilingual in Chinese and English

Benefits

  • Health Care Plan (Medical)
  • 401K
  • Paid Time-Off
  • Training & Development

We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.