• location: Durham, NC
  • type: Temp to Perm
  • salary: $30 - $36 per hour

job description


Manufacturing Scientist

Job Summary

The Manufacturing Scientist will be responsible for the manufacturing and testing of reagents and controls for an in vitro diagnostics Point of Care (POC) system in a highly regulated GMP/GLP setting under the direction of a Supervisor or Scientist. Additionally, this position will support development of new reagents, laboratory upkeep, and other duties as defined by the supervisor.

Job Responsibilities

  • Manufacture and test in vitro diagnostics reagents and controls following established procedures under the direction of a Supervisor or Scientist.
  • Conduct activities in compliance with laboratory safety, good laboratory practices, and design control requirements.
  • Manufacture and test reagents and controls following established procedures. Must be able to accurately and carefully maintain documentation as required under the regulated environment of design control.
  • Maintain and execute reagent and control stability studies.
  • Execute process validation and equipment validation studies.
  • Evaluate and troubleshoot performance of reagents and formulations.
  • Assist in executing process improvement studies to support formulations.
  • Provide support for special topics and problems that arise, as assigned and directed by the Supervisor or Scientist.
  • Support design changes and improvements under the direction of Supervisor or Scientist.
  • Assemble and analyze data, and summarize results, as directed.
  • Conduct protocol driven testing for process validation, equipment qualifications, and other improvement efforts.
  • Other programs as identified by the Supervisor.
Education & Qualifications

  • Bachelor's Degree in medical technology, or scientific, or engineering discipline required.
  • Minimum of 2 years' experience in medical device industry.
  • Experience in a manufacturing environment or Quality Control testing environment of in vitro diagnostics and/or coagulation laboratory products desirable.
  • Competence working with Microsoft Office, particularly Word and Excel.
  • Familiarity with statistical software desirable.
  • Training and education in a scientific field.
  • Must be able read and understand written instructions, and maintain detailed documentation.
  • Strong organizational skills and attention to detail are crucial for success in this position.
  • The ability to ask appropriate questions and follow direction to execute complex protocols for all studies.
  • Effective analytical, quantitative, and problem solving skills.
  • Strong written and verbal communication skills
  • The ability to work in a team driven environment
  • Training in laboratory safety practices: Bloodborne Pathogen, Hazardous Chemicals, PPE, Universal precautions, etc.

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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