Quality Assurance Specialist

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!

Purpose

The purpose of this position is to promote quality standards within the center and
ensure that center personnel follow quality policies and procedures. The QA
Supervisor escalates any non-compliance that affects plasma quality and has the
authority to stop plasma shipment release based on risk and discretion. Operates
within the scope of EU Guidance on Good Manufacturing Practices and FDA
cGMP 21CFR.

Key Accountabilities

1. Reviews plasma collection activities and donation records to determine if
records are in compliance with SOP and regulatory requirements and takes appropriate corrective actions.
2. Supervises work and output of other Quality staff in collaboration with Quality Management to train and develop in job-related duties.
3. Performs final QA review and release for all product shipments and associated documents to ensure shipments meet customer specifications.
4. Communicates with the Quality Management and Operations management regarding daily quality assurance/quality control issues affecting donor
suitability and/or product quality; develops and implements corrective actions when necessary.
5. Makes decisions about quality in the absence of the CQM and provides
support and guidance to other quality staff. Acts as deputy for CQM in their absence.
6. Ensures data integrity across all areas by auditing the plasma relevant
processes and documents to ensure attributability, completeness, consistency, and accuracy of records and documents within the quality system.
7. Prepares center and host customer, regulatory, and corporate audits of the center. In conjunction with the CQM, completes audit responses, including
corrective/preventive action, and ensures that responses are submitted in a timely manner.
8. Works as a team with quality and operations management to support and
assist center with non-conformance prevention, compliance and performance improvement of Key Performance Indicators.
9. Performs ongoing self-inspections and observations to ensure employees
correctly perform procedures; identifies deficiencies and works closely with training staff to correct any issues noted.
10. Assists with training and communicating SOP and regulatory changes to involved staff and ensures documentation of training is complete.

11. Analyzes tracking and trending data and determines appropriate actions to decrease center errors.
12. Reviews incoming softgoods and medical supplies to ensure accurate receipt and suitability for use.
13. Other job-related responsibilities as required.

Qualifications

1. Bachelor's degree in life science or related field, preferred.
2. Two years' experience in biologics, biotechnology or pharmaceutical industry with increasing quality responsibilities; or equivalent combination of education and experience.
3. Demonstrated knowledge of FDA and EU regulations and standards.
4. Strong written and verbal communication skills.
5. Plasma industry experience, preferred.
6. Eagerness to advance into leadership roles within the organization.

Physical and Mental Working Conditions
1. Occasionally required to travel overnight.
2. Frequently performs work while walking or standing.
3. Frequently exposed to bloodborne pathogens and may be required to wear personal protective equipment.
4. Occasionally required to be in work environment > - 30o C and appropriate personal protective equipment.
5. May be required to work flexible work schedule, including weekends and holidays.
6. Occasionally required to lift, push and pull up to 25 pounds.
7. Required to communicate and interact with employees, donors and regulatory
agencies.