Quality Sr. Scientist (Quality Assurance)

• 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 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.

• 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.

Additional Skills:

• 5 - 8 years quality experience.

• GMP required

• Minimum BS/BA required

For more information, Please contact

Best Regards,

Atul Soni

(973) 295-4554 Ext.4554

Morristown, NJ 07960