Quality Assurance Specialist
Company: Advanced Bioservices LLC
Location: Youngstown
Posted on: January 19, 2023
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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.
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! If you would like further details
regarding the benefits we offer please let us know, and we would be
glad to provide you with our full benefits guide, as well as
answering any questions you may have! 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.
Keywords: Advanced Bioservices LLC, Youngstown , Quality Assurance Specialist, Other , Youngstown, Ohio
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