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Quality Assurance Scientist II
2 months ago
The Quality Scientist II role is integral to the execution of department-specific functions, adhering to all relevant cGMP standards and aligning with corporate and site protocols, regulations, and policies. This position involves the coordination and processing of daily samples with minimal oversight from the Team Leader, ensuring the completion of testing. Additionally, the role encompasses participation in investigations and projects aimed at enhancing productivity within the Quality Control Laboratories.
Key Responsibilities
- Conduct testing on in-process samples, blended vaccines, and final containers for all relevant assays while employing good aseptic techniques with limited supervision.
- Understand the performance metrics and trends of the assays managed, maintaining all critical reagents with minimal guidance.
- Prepare media and reagents as required.
- Engage in Media Fill inspections.
- Maintain testing schedules with minimal direction.
- Complete documentation in accordance with cGMP standards.
- Draft, execute, and report on validation studies and investigational protocols.
- Write and update Standard Operating Procedures and Standard Methods.
- Document investigations as necessary, utilizing Method 1 and the DMAIC process.
- Clean and maintain laboratory equipment, instruments, and facilities.
- Provide minimal input for laboratory investigations (LIR) and support projects as needed.
- Familiarity with QC software packages utilized in routine operations.
- Perform pipetting tasks.
- Conduct pH and appearance testing.
- Execute egg drilling procedures.
- Participate in Media Fill inspections.
- Monitor equipment as required.
- Conduct Gram Stain work.
- Adhere to all Zoetis Quality Standards, Policies, and Procedures.
- BA/BS in a STEM field or an AA with 1-3 years of relevant experience.
- General proficiency in software applications such as Word, Excel, and PowerPoint.
- Willingness to adapt positively to change and flexibility in responding to shifting priorities.
- Strong attention to detail, capability to work independently and collaboratively, and ability to interact effectively with individuals at all organizational levels.
- Achieve proficiency in 50% of the testing within a designated area.
- Able to follow detailed instructions with guidance.
- Understanding of basic GLP requirements.
- Basic problem-solving skills and troubleshooting capabilities.
- Ability to walk, sit, or stand for extended periods.
- Capability to reach above shoulder level, bend, stoop, kneel, push, pull, and grip frequently.
- Willingness to work a standard 40-hour schedule with potential overtime as needed.
- Frequent lifting and carrying of items weighing between 5 to 25 lbs.
- Regular reaching, bending, stooping, and twisting motions.
- Repetitive motions involving substantial movement of wrists, hands, and fingers.
- Flexibility to cover rotating weekend duties.
- Ability to grasp and manipulate laboratory tools such as pipettors, flasks, and bottles.