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Quality Assurance Manager

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Job Details
Job Order Number
JC146362283
Company Name
Kedrion Biopharma, Inc.
Physical Address

Mobile, AL 36607
Job Description

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

DUTIES AND RESPONSIBILITIES:

1. QAM is responsible for oversight of all activities relating to product quality.

2. QAM should work in collaboration with Center Manager to assure product quality.

3. The QAM should coordinate, monitor, and facilitate all QA activities.

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

5. 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.

6. 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.

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

8. 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.

9. Reviewing and ensuring written approval of all DCOPs prior to implementation and confirming that DCOP comply with all applicable statutory and regulatory requirements. Additionally, prior to the implementation of each DCOP, the QAM ensures:

a. Identification of personnel responsible for performing each procedure

Procedures for training are in place and certifying individuals identified.

c. Responsibilities of supervisors for oversight of the performance of all procedures are in place;

d. Methods for periodic proficiency testing

e. Methods for periodic competency evaluation of the individuals performing each procedure;

f. Methods for evaluating the performance of each procedure during QA audits;

g. Instructions for records maintenance consistent with requirements for recordkeeping.

10. Participate in updating Donor Center Operating Procedures (DCOPs) and validating processes.

11. Review quality issues with Center Manager periodically and as needed.

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

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

14. 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.

15. Oversee and review tasks of Quality Assurance Specialists (QAS). This may include evaluation and counseling of the QAS with Center Manager.

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

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

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

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

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

21. Encourage and participate in continuous quality improvement process.

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

23. Ensure that all staff is trained and maintain their competency to perform all assigned tasks; the QAM should implement a formal regular competency evaluation program. A competency evaluation program should evaluate theoretical and practical knowledge of procedures including, but not limited to, 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;

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.

24. 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 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.


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