Quality Scientist II

Position Summary:

This Quality Scientist II position is responsible for executing department specific tasks in accordance with all applicable cGMPs and compliant with Corporate/site procedures, regulations, and policies.  This role will be 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. 

Position Responsibilities:

• 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:

BS/BA (science background preferred) and/or AA plus 3 years’ experience.

• Knowledge of cGMP/GLP requirements.

Technical Requirements:

• Proficient in Microsoft Word, Excel, and PowerPoint, with the ability to leverage advanced features for data analysis, reporting, and presentation development.
• 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.
• Proactively seeks out opportunities for improvements and acts with minimal direction.
• Applies problem solving skills in a team environment.
• High level of understanding of multiple technologies and/or assays within the workgroup.
• Proficiency of 70% of the testing within the workgroup.
• Project work that may have unit impact.

Physical Requirements:

• Must be able to walk, sit, or stand for long periods of time.
• Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
• Must be able to work scheduled 40 hours with the ability to work overtime as needed.
• Must be able to work weekends as needed.
• Frequent lifting and carrying of 5 to 25 lbs.
• Regular reaching, bending, stooping, and twisting.
• Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
• Ability to grasp and manipulate objects like pipettors, flasks, and bottles.
• Flexibility to cover rotating weekend duties.