Artech Information System LLC
Quality Sr. Scientist (Quality Assurance)
Artech Information System LLC, Sanford, North Carolina, United States, 27330
Quality Sr. Scientist (Quality Assurance)
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Responsibilities may include:Providing Quality Review/Oversight of site GMP documentation related to the operation of a vaccine manufacturing facility to ensure compliance with global regulatory agencies and Pharmaceutical quality standards.Performing testing including, but not limited to clinical and/or commercial product, raw materials, and validation samples.Displaying strong investigative or technological orientation with independence for design of projects/studies.Organizing and providing written and/or oral presentations of work with minimal input.Analyzing and interpreting results, making decisions regarding the accuracy, completeness, and compliance.Responsible for final authorization/approval/release of documentation/equipment/processes.Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility.Planning and leading projects to ensure their timely completion.Providing guidance/coaching to junior colleagues.WORK EXPERIENCE/SKILLS:MINIMUM:
5 - 8 years of manufacturing, quality, or engineering experience in the biotech or pharmaceutical industry.DESIRABLE: EDUCATIONAL BACKGROUND:MINIMUM:
BS/BA Degree in Science/related field or other appropriate education/experience in biotech or pharmaceutical industry.DESIRABLE:University Degree in the field of Engineering, Microbiology, Chemistry, Biotechnology, Biochemistry, or Pharmacy or other appropriate education and experience in biotech or pharmaceutical industry is preferred.
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Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.Responsibilities may include:Providing Quality Review/Oversight of site GMP documentation related to the operation of a vaccine manufacturing facility to ensure compliance with global regulatory agencies and Pharmaceutical quality standards.Performing testing including, but not limited to clinical and/or commercial product, raw materials, and validation samples.Displaying strong investigative or technological orientation with independence for design of projects/studies.Organizing and providing written and/or oral presentations of work with minimal input.Analyzing and interpreting results, making decisions regarding the accuracy, completeness, and compliance.Responsible for final authorization/approval/release of documentation/equipment/processes.Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility.Planning and leading projects to ensure their timely completion.Providing guidance/coaching to junior colleagues.WORK EXPERIENCE/SKILLS:MINIMUM:
5 - 8 years of manufacturing, quality, or engineering experience in the biotech or pharmaceutical industry.DESIRABLE: EDUCATIONAL BACKGROUND:MINIMUM:
BS/BA Degree in Science/related field or other appropriate education/experience in biotech or pharmaceutical industry.DESIRABLE:University Degree in the field of Engineering, Microbiology, Chemistry, Biotechnology, Biochemistry, or Pharmacy or other appropriate education and experience in biotech or pharmaceutical industry is preferred.
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