Quality Assurance Specialist
Company: Kedrion Biopharma, Inc.
Location: Las Vegas
Posted on: May 14, 2022
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.
Duties and Responsibilities:
- Ensure general understanding of all applicable state, federal
regulations, industry and corporate policies.
- Ensure that production personnel follows compliance of all
Center activities with cGMP, Kedplasma DCOPs (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.
- 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.
- Review and investigate final shipment release deviations
including accurate labeling and documentation of
shipments.
- Determining that DCOPs 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.
- Participate in review of Donor Center Operating Procedures
(DCOPs) and validating processes.
- Review quality issues with QAM and Center Manager periodically
and as needed.
- Review compliance issues with appropriate staff and their
supervisions.
- Provide accurate reports of the facilitys compliance to QAM,
Regional Manager and/or VP of QA/RA.
- 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.
- Participate in comprehensive internal and external audits of
the facility
- Ensure correct documentation and computer use and archiving or
backup including donor files.
- Ensure that supplies and equipment are received, maintained,
stored and documented to meet quality regulations.
- Review qualification, calibration and maintenance, repair and
operation of equipment and documentation of use.
- Ensure QC checks are performed on all units and cases of
products stored and shipped by the center.
- Ensure QC checks are performed as required and in acceptable
ranges for controls and test reagents.
- Encourage and participate in continuous quality improvement
process.
- Monitor, prepare and submit epidemiological data for PPTA or in
corporate required format(s).
- 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.
- Ensure that CLIA proficiency testing, complaint investigations
and staff training and certifications are properly performed and
documented.
JOB SPECIFICATIONS:
- Bachelors 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.
- Excellent communication skills and ability to conduct oral
presentations.
- Excellent people skills which extends to a diverse group of
individuals and demographics.
- Three to five years of working experience in a biomedical field
preferred.
- Ability to speak read and write in English. Professional
appearance and demeanor.
- Ability to operate computer software including DMS (with
training), eQue and Microsoft Office.
PHYSICAL REQUIREMENTS:
- Ability to sit or stand for up to four (4) hours at a
time.
- Ability to tug, lift, and pull up to fifty (50)
pounds.
- Be able to bend, stoop or kneel and climb stairs and/or
ladder.
- Occupational exposure to blood-borne pathogens.
- Able to travel by plane and drive car.
- While performing the duties of this job, the employee is
regularly required to stand; use hands to handle or feel objects,
tools or controls.
Keywords: Kedrion Biopharma, Inc., Las Vegas , Quality Assurance Specialist, Other , Las Vegas, Nevada
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