Specialist, Quality Assurance - 1st

Position Overview:

The Specialist is expected to support FSQA. The role serves as a primary backup to the QA SUpervisor. The qualified

individual should have previous experience of working in a laboratory environment and should have a good understanding of

the manufacturing process and of QA requirements. Good attention to detail and analytical skills are necessary.

Essential Duties and Responsibilities:

· Provide wide-ranging support for FSQA activities.

· Administer environmental program monitoring and corrective actions.

· Support and serve as a primary backup to the QA Supervisor.

· Assist with the management of Quality Assurance equipment.

· Develop and maintain the shelf-life study program.

· Perform other duties as assigned.

Competencies and Skills: Physical Demands:

· Understanding of QA principles and analysis methods.

· Knowledge of microbiological Sampling Methods and aseptic techniques.

· Proficiency in using a variety of computer software.

· Ability to learn new monitoring and sampling methods and techniques and teach them to others.

· Good analytical skills and the ability to detect trends.

· Strong attention to detail and the ability to work with precision.

- Good organizational and time management skills.

Physical Demands:

· Ability to sit for prolonged periods of time in front of a computer.

· Ability to stand and move about the laboratory for prolonged periods.

· Ability to perform physical activities, such as lifting items of up to 50 lbs. unassisted, bending, standing, climbing, or walking.

· Visual and hearing acuity.

Education and Experience:

Works in a manufacturing plant and in a general office environment.

Will be required to wear suitable Personal Protective Equipment as needed.

May occasionally be exposed to wet, humid conditions, inclement weather, and extreme temperatures.

May, on rare occasions, be exposed to oils, airborne particles, vibration, and the risk of electric shock.

May, on rare occasions, be required to work near moving mechanical parts and in a highly dangerous place.