Under the supervision of the Center Quality Assurance Manager and Center Director, perform Quality Assurance functions as a member of the Quality Assurance Unit (QAU) to ensure compliance with all applicable state, federal, customer, and European regulations and ImmunoTek requirements. This role does not perform operational tasks.
ESSENTIAL JOB FUNCTIONS:
1.Maintains current knowledge of FDA, EU, and applicable state regulations in addition to customer specifications.
2.Ensure all product shipments comply with all federal, state, customer, and ImmunoTek requirements.
3.Ensure sample shipments are accurately labeled and shipped to testing laboratory.
4.Ensure donor center records are complete and accurate.
5.Ensure that supplies and materials meet requirements.
6.Ensure compliance with SOPs and that SOP revisions are implemented correctly. Including system process assessments to make the systems more efficient and effective.
7.Assist center Quality Assurance Manager and Center Management to develop Corrective Actions for inspection findings; ensure they are implemented and effective.
8.Ensure that equipment is maintained and calibrated properly.
9.Ensure that proficiency test surveys and employee training are documented properly.
10. Ensure deviation investigations are handled appropriately. Respond to QA Tracking and Trending errors, external audit findings, and internal audit findings.
a. Recommend Corrective and Preventative Action Plans (CAPA) to Operations for implementation.
b. Monitor and evaluate adequacy of Corrective and Preventative Actions, completeness of reports, assist in root cause analysis.
c. Investigate and propose additional corrective actions as required.
11. Ensure compliance with SOPs and that SOP revisions are implemented correctly.
12. Train center staff, as required, on new SOPs, SOP revisions, corrective and preventive actions.
13. Train other designated staff in performing the functions of the QAS position.
14. Perform other duties as assigned.
1.Undergraduate degree in science or minimum of 2 years plasma center experience required. Previous work experience demonstrating decision making ability, ability to effectively communicate with and positively influence people, familiarity with fiscal operations, supervisory responsibility, conflict resolution, and customer service.
2.Excellent communication skills and ability to conduct oral presentations.
3.Excellent people skills which extends to a diverse group of individuals and demographics.
4.Three to five years of working experience in a biomedical field preferred.
5.Ability to speak read and write in English. Professional appearance and demeanor.
6.Ability to operate computer software including DMS (with training), eQue and Microsoft Office.
1.Ability to sit or stand for up to four (4) hours at a time.
2.Ability to tug, lift, and pull up to fifty (50) pounds.
3.Be able to bend, stoop or kneel and climb stairs and/or ladder.
4.Occupational exposure to blood-borne pathogens.
5.Able to travel by plane and drive car.
6.While performing the duties of this job, the employee is regularly required to stand; use hands to handle or feel objects, tools or controls.
The usual work environment is in all areas of an operating plasma center and requires reasonable level of mobility and adaptability. The employee may be exposed to blood borne pathogens or freezing temperatures for short periods of time.