QA Auditor I

🔍 Middleton, Wisconsin, United States

📁: Quality Assurance and Complian

📅   : Oct 03, 2019 Post Date

📅   : 2384 Total Views

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Education and Experience:

•Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree

•Previous QA or analytical lab experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years) or equivalent combination of education, training, & experience.

• Preferred: Degree in Chemistry, Biology, or related field

Knowledge, Skills and Abilities:

• Familiar with applicable GMP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelines)
• Thorough working knowledge of SOPs and WPDs
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Strong attention to detail
• Able to work independently or in a team environment
• Good problem-solving abilities
• Good organizational and time management skills
•Basic computer skills and ability to learn and become proficient with appropriate software
•Proven flexibility and adaptability

Working Conditions and Environment:

•Work is performed in an office/ laboratory and/or a clinical environment.
•Exposure to biological fluids with potential exposure to infectious organisms.
•Exposure to electrical office equipment.

•Personal protective equipment required such as protective eyewear, garments and gloves.

Physical Requirements:

•Ability to work in an upright and /or stationary position for 6-8 hours per day.
•Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
•Frequent mobility required.
•Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
•Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop
computer with a maximum lift of 15-20 lbs.
•Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
•Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
•Frequently interacts with others to obtain or relate information to diverse groups.
•Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
•Regular and consistent attendance.