Quality Sr. Scientist (Quality Assurance)

Artech Information System LLC; Sanford (NC); On-site; USD 85,000 - 115,000; Full time

Job summary

A leading IT staffing company is looking for a Quality Sr. Scientist specializing in quality assurance. The role focuses on laboratory testing within a GMP environment to ensure compliance with regulatory standards. Ideal candidates should have 5-8 years of experience in the biotech or pharmaceutical industry and a relevant degree. Responsibilities include overseeing GMP documentation, performing various tests, and leading quality improvement projects. This position offers an opportunity to contribute to the development of high-quality pharmaceutical products.

Qualifications

• 5 - 8 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
• Strong investigative or technological orientation.
• Experience with GMP documentation.

Responsibilities

• Providing Quality Review/Oversight of site GMP documentation.
• Perform testing including clinical and commercial products.
• Analyze and interpret results, making decisions regarding compliance.
• Plan and lead projects to ensure timely completion.

Skills

Quality Review/Oversight

Laboratory Testing

Analytical Skills

Project Management

Coaching

Education

BS/BA Degree in Science or related field

University Degree in Engineering, Microbiology, Chemistry, Biotechnology, Biochemistry, or Pharmacy

Job description

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.