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.