Quality Associate III

Job Description:
The Quality Associate provides frontline data analysis and reporting for the Quality Control Environmental Assurance Laboratories.
The incumbent should be able to make decisions within their assigned areas and must have strong oral and written communication skills with the ability to effectively communicate ideas to people with varying degrees of technical understanding.
Strong computer skills are essential and a working knowledge of statistical data analysis is beneficial. A firm understanding of Excel is required.
Experience with SAP preferred.

Key Job responsibilities include:

• Identify and process deviation records for microbial excursions and trends.
• Perform cause investigations and product impact assessments for identified deviations. Analyze trend and summarize the environmental monitoring data in a variety of reports and review specific reports with affected business units.
• Demonstrate strong technical expertise and ability to answer questions related to assigned tasks/areas. Communicate effectively and promptly with all levels of the organization supporting department objectives and management decisions.
• Know and demonstrate the requirements for Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Perform nonroutine duties housekeeping duties etc. as assigned.

Educational Requirements:

• QA II MS degree in a relevant discipline (i.e. Biology Microbiology etc.) with minimal experience or a BA/BS degree in a relevant discipline and a minimum of 2 years of related experience or equivalent combination of education and experience.
• QA III MS degree in a relevant discipline (i.e. Biology Microbiology etc.) with a minimum of 2 years of related experience or a BA/BS degree in a relevant discipline and a minimum of 4 years of related experience or equivalent combination of education and experience.
• Depending on the area of assignment directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements
• Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office and laboratory equipment.
• Personal protective equipment required such as protective eyewear garments and gloves.
• Work is performed sitting or standing for 24 hours per day.
• Frequent hand movement of both hands with the ability to make fast simple movements of the fingers hands and wrists.
• Ability to make precise coordinated movements of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying objects with a maximum lift of 35lbs.
• Occasionally walks bends and twists neck and waist may reach above or below shoulder height.
• Frequent foot movements.
• This job description is intended to present the general content and requirements for the performance of this job.
• The description is not to be construed as an exhaustive statement of duties responsibilities or requirements. Managers and supervisors may assign other duties as needed
• This role is mostly an office job working with Quality paperwork and investigations. Contract employees will go into lab areas to gather paperwork and information but will not be performing lab tests.
• This role involves a lot of Excel work so candidates should be very strong in their Excel skills. SAP experience is a plus but not required.