Quality Assurance Specialist

Job Description

Job Description

KEDPLASMA provides a friendly and rewarding working environment with frequent opportunities for cross-training and advancement.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.

Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.

S. For more information on E-verify, please contact the Dept. of Homeland Security.

Kedrion Biopharma & KEDPLASMA offer a number of benefits to qualifying employees, including :

• Medical, vision and dental insurance
• Life and AD&D insurance
• Paid holidays
• PTO accrual
• and much more!

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

Please note that salary ranges are calculated based off levels of : relevant experience, education and certifications.

Duties and Responsibilities :

1. Ensure general understanding of all applicable state, federal regulations, industry and corporate policies.

2. Ensure that production personnel follows compliance of all Center activities with cGMP, Kedplasma DCOP’s (Donor Center Operating Procedures) and other Company standards and protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required.

3. Ensure plasma release and shipments meet specifications and requirements as defined by customers and in DCOPs. When necessary, should have the authority to stop production and / or release of product.

4. Review and investigate final shipment release deviations including accurate labeling and documentation of shipments.

5. Determining that DCOP’s exist for all manufacturing procedures including, but not limited to, testing, and that DCOPs accurately describe and define the procedure, including a statement of what the procedure is intended to accomplish.

6. Participate in review of Donor Center Operating Procedures (DCOPs) and validating processes.

7. Review quality issues with QAM and Center Manager periodically and as needed.

8. Review compliance issues with appropriate staff and their supervisions.

9. Provide accurate reports of the facility’s compliance to QAM, Regional Manager and / or VP of QA / RA.

10. Investigate, track / trend and follow up on corrective actions and preventative measures for center non-conformances and E&A, as well as provide analysis of preventive action on all incidents / errors as required.

11. Participate in comprehensive internal and external audits of the facility

12. Ensure correct documentation and computer use and archiving or backup including donor files.

13. Ensure that supplies and equipment are received, maintained, stored and documented to meet quality regulations.

14. Review qualification, calibration and maintenance, repair and operation of equipment and documentation of use.

15. Ensure QC checks are performed on all units and cases of products stored and shipped by the center.

16. Ensure QC checks are performed as required and in acceptable ranges for controls and test reagents.

17. Encourage and participate in continuous quality improvement process.

18. Monitor, prepare and submit epidemiological data for PPTA or in corporate required format(s).

19. Ensure that all staff is trained and maintain their competency to perform all assigned tasks; Helps QAM to evaluate the following : a.

• Direct observations of performance of routine and quality control procedures including, as applicable, donor suitability, sample handling, processing, testing, labeling, and instrument preventive maintenance;
• b. Monitoring the recording and reporting of test results by reviewing work sheets, quality control records ,preventive maintenance records, and other records and entries (both manual and automated);

c. Written tests to assess problem solving skills, knowledge of DCOPs, and theory; and

d. Assessment of performance using internal blind specimens and external proficiency test specimens.

Minimum acceptable scores, performance, and remedial measures to correct inadequate performance on competency evaluations should be documented and retained in personnel records.

Evaluation summaries provide useful information to correct individual or group performance problems.

20. Ensure that CLIA proficiency testing, complaint investigations and staff training and certifications are properly performed and documented.

JOB SPECIFICATIONS :

1. Bachelor’s 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.

PHYSICAL REQUIREMENTS :

1. Ability to sit or stand for extended periods of 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.