Quality Control Scientist

2 weeks ago

Livingston, New Jersey, United States CooperCompanies Full time
About CooperCompanies

CooperCompanies is a leading provider of innovative solutions for the healthcare industry, dedicated to delivering high-quality products and services that enhance the lives of patients and healthcare professionals.

Job Summary

We are seeking a highly skilled Quality Control Scientist to join our team at CooperCompanies. As a Quality Control Scientist, you will be responsible for establishing, developing, implementing, maintaining, and improving laboratory processes and QC programs to ensure the highest level of quality and performance.

Key Responsibilities
  • Design, develop, and implement visualization tools to define statistical quality control metrics and ensure resulting confidence and performance consistency.
  • Partner with stakeholders to improve the quality of laboratory processes and output of data.
  • Analyze and interpret processing data, generating insights for operational partners.
  • Facilitate meetings to review processing data and interpretation, and provide support in the day-to-day processing and investigations for Deviations, Nonconformances, and CAPAs.
  • Implement, test, maintain, and customize available/known informatics resources and scientific software/data sources in multiple programming languages/platforms for research support.
  • Investigate, customize, and prototype new bioinformatics resources and scientific software for biomedical data processing.
  • Design, develop, and deploy Quality Control data metrics models to ensure the performance and output of laboratory processes are maintained within specification.
  • Collaborate with laboratory scientists, laboratory data management team, and other subject matter experts to provide statistical support for clinical laboratory processing and research projects involving laboratory data.
  • Generate written summaries for use in customized statistical lab reports.
  • Maintain functional understanding of standard policies and procedures and complete required training in a timely manner.
  • Contribute to the development and maintenance of standard procedures and related quality control laboratory documents ensuring the accuracy and reliability of results.
  • Contribute to and review study documents, including protocol drafts, statistical analysis plans, and other documents as required.
  • Facilitate meetings, provide data from tracking and trending, lead quality and continuous improvements, and prepare reports for internal and external communication of results.
  • Develop and implement tools for custom sets of NGS data, including alignment, barcoding, and analysis/quantification.
  • Work closely with the software engineering team in development and deployment of both automated production systems and scientist-driven data analysis platforms.
  • Provide guidance on experimental protocol design geared toward powering data insights, including scale and quality thresholds.
  • Develop novel computational methods for analyses of multi-omics data, identify gaps in existing methods/tools, and develop novel solutions to bridge them.
  • Identify new proactive computational data metrics that can aid in process and product improvement opportunities.
  • Build and implement computational biology capabilities to translate biological data into insights.
Requirements
  • Master's Degree in Bioinformatics/Computer Science/Bioengineering/Computational Biology or related field.
  • Six Sigma Certification a plus.
  • Over 4 years of experience working as a biostatistician in the pharmaceutical, biotechnology, or medical device industry.
  • Solid grounding in molecular biology, genetics, and statistical methods.
  • Experience in non-clinical statistics, laboratory testing, and/or manufacturing process control.
  • Demonstrated ability to understand and implement computational algorithms, statistical analysis methods, custom data analysis software.
  • Demonstrated proficiency in software development in multiple programming languages, such as Python/Java, and derivatives.
  • Demonstrated proficiency in software engineering processes, such as version control, backup, documentation, testing, validation.
  • Demonstrated proficiency in downloading/learning/applying software and database resources for custom analysis and building workflows.
  • Demonstrated proficiency with scientific computing and data visualization tools and understanding of basic statistics.
  • Demonstrated familiarity with large-scale data analysis and utilization of high-performance computing systems, parallel programming.
  • Demonstrated proficiency with NGS workflow processes and languages.
  • Excellent verbal and written communication skills.
  • Collaborative personality with strong interpersonal skills.
  • Ability to work effectively in a cross-functional, team environment that includes computational biologists, statistical geneticists, bioinformaticians, engineers, and program managers.

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