The Quality Assurance Specialist, under the supervision of the Quality Assurance Manager will assist in all daily quality responsibilities of the donor center, ensuring compliance with all applicable state, federal, customer, European regulations, and ImmunoTek requirements. The Quality Assurance Specialist responsibilities include reviewing daily manufacturing records and donor records. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If you need an accommodation, please notify your immediate supervisor to begin the interactive process.
Essential Job Functions
Review daily manufacturing records and donor record files.
Perform equipment quality control review.
Review donor deferrals.
Verification and release of plasma sample shipments.
Inspection and release of daily supplies.
Quality release of plasma for shipment.
Conduct employee performance observations.
Review the documentation related to test results and the disposition of the associated units.
Participate in internal leadership meetings as part of the Quality Assurance Team as needed.
The Quality Specialist may also be asked to:
Document, investigate, and perform root cause analysis for deviations.
Review equipment records.
Waste shipment review.
Review product quality information.
Review Donor Incident Reports.
Provide product lookback information.
Initiate investigations that have not met quality specifications within the center.
Education & Experience
High school diploma or GED required.
Undergraduate degree in Science preferred.
Minimum of 2 years plasma center experience preferred.
In order for an incumbent to successfully perform the essential functions of this job, they should be able to demonstrate the following:
Good oral and written communication skills
Provide a good customer service experience
Ability to read and interpret directions and instructions
Accurate data entry
Perform basic math calculations
Reasoning ability to identify, interpret and apply appropriate information
Physical Requirements of the Job
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to:
Use hands to handle or feel objects, tools, or controls; reach with hands and arms; and talk or hear.
Frequently required to stand; walk, climb or balance; and stoop, kneel, or crouch.
Ability to stand for extended periods of time for up to four (4) hours at a time.
Ability to lift, tug, pull up to fifty (50) pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
Noise level are usually moderate. Moderate is described as average.
May be exposed to freezing temperatures for short periods of time.
Occupational exposure to bloodborne pathogens.
Every organization is solidified by the sturdiness of its foundation. At ImmunoTek Bio Centers, LLC, our Core Values are our guide to everyday work and interactions that we have with each other, our donors and our customers. By aligning our words and actions in accordance with the Core Values, this allows the #plasmapeople to breed authenticity. As PLASMA PEOPLE, we demonstrate:
Passion for people through our relationships with Employees, Donors, and Patient Recipients.
Leadership at all levels of the organization by maintaining integrity in all of our interactions.
Accountability by proactively taking ownership of our work.
Service Excellence through our collective effort to deliver positive experience to our donors, customers, vendors, and partners.