Quality Sr. Scientist (Quality Assurance)
Artech Information System LLC
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. Job Overview The correct title for this position is Quality Sr. Scientist (Quality Assurance). Primarily focused on laboratory testing in a GMP area, with a focus on execution of test methods in support of assay validation. Responsibilities 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. Performs testing including, but not limited to clinical and/or commercial product, raw materials and validation samples. Displays strong investigative or technological orientation with independence for design of projects/studies. Organizes and provides written and/or oral presentations of work with minimal input. Analyzes and interprets results, makes 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. Plans and leads projects to ensure their timely completion. Provide 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. #J-18808-Ljbffr Artech Information System LLC
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