You are viewing a preview of this job. Log in or register to view more details about this job.

Quality Scientist II JR00006938

This Virology Quality Scientist II position is responsible for executing department specific tasks in accordance with all applicable cGMPs and compliant with global/site procedures, regulations and policies. This role is responsible for the construct and testing of blended vaccines and antigen stocks using egg-based methodologies, with minimal direction from Team Leader, to ensure testing is complete. The successful incumbent is expected to perform analyses required for incoming, in-process and finished goods as required by specifications as well as all other quality control testing to support qualification/validation, transfers and other project related activities for biologic animal vaccines. In addition, this role will also participate in investigations and/or projects to increase productivity in the Quality Control Labs. 

  • Testing of samples from manufacturing to ensure Quality and compliance according to all applicable assays utilizing good aseptic practices.
  • Performed analyses which includes extraneous, sterility, stability, inactivation, and potency testing required for incoming, in-process and finished goods as required by specifications.
  • Maintain testing schedules with minimal direction and guidance
  • Execute and report validation studies
  • Write and revise Standard Operating Procedures and Standard Methods
  • Support Investigations when necessary utilizing Method 1 and the DMAIC process
  • Clean and maintain lab equipment, instrumentation and facilities
  • Properly navigate the QC software packages used during routine work
  • Preparation of media and reagents
  • Participate in Media Fill inspections
  • Responsible for monitoring of lab equipment
  • Solid understanding of several of the basic technologies for their specified workgroup and be able to work independently. 
  • Understand the basic functions of other parts of the organization.
  • The colleague may participate on simple projects or participate as part of a team on larger projects.
  • Maintain appropriate departmental cGMP documentation.
  • Execute all written procedures.
  • Effectively work in a team environment and communicate with multiple departments

Education and Experience:
4 Year Degree (science background preferred) and/or AA and 3 year of relevant experience

  • General knowledge of the following software programs: Word, Excel, and Powerpoint
  • Strong attention to detail, ability to work well independently and as a part of a team, and to work effectively with people at all levels within the organization.
  • Gain Proficiency in 70% of the testing in a specified area.
  • Able to follow detailed instructions with minimal coaching
  • Knowledge of Basic GLP requirements.
  • Strong Problem solving skills and should demonstrate troubleshooting ability.
  • Project work that may have unit impact.

Ability to lift approximately 20 pounds.
Flexibility to cover rotating weekend duties.
Ability to grasp and manipulate objects like pipettors, flasks, and bottles.