Quality Assurance Specialist

3 weeks ago

Duncanville, Texas, United States Kedrion Biopharma Inc. KEDPLASMA LLC. Full time
Job Overview

Kedrion Biopharma Inc. KEDPLASMA LLC. is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our plasma center operations.

Key Responsibilities
  1. Regulatory Compliance: Ensure that all applicable state, federal regulations, industry, and corporate policies are understood and implemented.
  2. Quality Control: 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. Product Release: Ensure that plasma release and shipments meet specifications and requirements as defined by customers and in DCOPs. When necessary, have the authority to stop production and/or release of product.
  4. Deviation Investigation: Review and investigate final shipment release deviations including accurate labeling and documentation of shipments.
  5. Procedure Development: Determine 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. Process Validation: Participate in review of Donor Center Operating Procedures (DCOPs) and validating processes.
  7. Quality Issue Review: Review quality issues with QAM and Center Manager periodically and as needed.
  8. Compliance Review: Review compliance issues with appropriate staff and their supervisions.
  9. Reporting: Provide accurate reports of the facility's compliance to QAM, Regional Manager and/or VP of QA/RA.
  10. Corrective Action: 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. Audit Participation: Participate in comprehensive internal and external audits of the facility.
  12. Documentation: Ensure correct documentation and computer use and archiving or backup including donor files.
  13. Supply Management: Ensure that supplies and equipment are received, maintained, stored and documented to meet quality regulations.
  14. Equipment Maintenance: Review qualification, calibration and maintenance, repair and operation of equipment and documentation of use.
  15. Quality Control Checks: Ensure QC checks are performed on all units and cases of products stored and shipped by the center.
  16. Training and Development: Ensure that all staff is trained and maintain their competency to perform all assigned tasks; Helps QAM to evaluate the following:
  17. Performance Evaluation: Direct observations of performance of routine and quality control procedures including, as applicable, donor suitability, sample handling, processing, testing, labeling, and instrument preventive maintenance;
  18. Record Review: 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);
  19. Written Tests: Written tests to assess problem solving skills, knowledge of DCOPs, and theory; and
  20. Competency Evaluation: 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.

Additional Responsibilities

  1. CLIA Proficiency Testing: Ensure that CLIA proficiency testing, complaint investigations and staff training and certifications are properly performed and documented.

Requirements

  1. Education: 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. Communication Skills: Excellent communication skills and ability to conduct oral presentations.
  3. People Skills: Excellent people skills which extends to a diverse group of individuals and demographics.
  4. Experience: Three to five years of working experience in a biomedical field preferred.
  5. Language Skills: Ability to speak read and write in English. Professional appearance and demeanor.
  6. Computer Skills: Ability to operate computer software including DMS (with training), eQue and Microsoft Office.

Physical Requirements

  1. Physical Ability: Ability to sit or stand for extended periods of time.
  2. Lifting: Ability to tug, lift, and pull up to fifty (50) pounds.
  3. Mobility: Be able to bend, stoop or kneel and climb stairs and/or ladder.
  4. Occupational Exposure: Occupational exposure to blood-borne pathogens.
  5. Travel: Able to travel by plane and drive car.
  6. Work Environment: While performing the duties of this job, the employee is regularly required to stand; use hands to handle or feel objects, tools or controls

  • Quality Assurance Specialist

    3 weeks ago

    Duncanville, Texas, United States Kedrion Biopharma Inc. KEDPLASMA LLC. Full time

    Job OverviewKedrion Biopharma Inc. KEDPLASMA LLC. is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our plasma collection operations.Key ResponsibilitiesRegulatory Compliance: Ensure that all applicable state, federal...

  • Data Management Specialist

    1 week ago

    Duncanville, Texas, United States Heidelberg Materials US, Inc. Full time

    Job Title: Manager of Data ManagementHeidelberg Materials US, Inc. is seeking a highly skilled Data Management Specialist to lead our Data Management Services team in Irving, Texas.The successful candidate will be responsible for developing and overseeing the organization's data management strategy, ensuring the effective collection, storage, and utilization...

  • Insurance Verification Specialist

    3 weeks ago

    Duncanville, Texas, United States Baylor Scott & White Health Full time

    Job SummaryThe Insurance Verification Specialist 2 plays a critical role in ensuring timely verification of insurance benefits and financial clearance, which has a direct impact on the organization's reimbursement from payers for patient accounts. This position requires strong communication and problem-solving skills to address complex issues and manage...

  • Dialysis Registered Dietitian

    1 month ago

    Duncanville, Texas, United States U.S. Renal Care Full time

    Job SummaryAs a Dietitian at U.S. Renal Care, you will play a vital role in the care of patients with kidney disease. You will work collaboratively with a cross-functional team to ensure patients receive the best possible care.Key ResponsibilitiesConduct patient assessments and develop care plans in consultation with physicians.Recommend therapeutic diets...

  • Dialysis Registered Dietitian

    4 weeks ago

    Duncanville, Texas, United States U.S. Renal Care Full time

    Job Title: Dialysis Registered DietitianAbout the RoleAs a Dialysis Registered Dietitian at U.S. Renal Care, you will be part of a dynamic team dedicated to providing exceptional care to patients with kidney disease. Your expertise in nutrition will play a vital role in ensuring our patients receive the best possible care.Key ResponsibilitiesConduct patient...

  • Emergency Medical Technician

    3 weeks ago

    Duncanville, Texas, United States AMR Corp. Full time

    Job Description:We are seeking a skilled Paramedic to join our team at AMR Corp. in Arlington, TX. As a Paramedic, you will be responsible for providing high-quality patient care and delivering compassionate service to our customers.Responsibilities:Assess each call situation to determine the best course of action while working with progressive Paramedic...

  • Culinary Specialist

    4 weeks ago

    Duncanville, Texas, United States Red Lobster Full time

    Red Lobster - 603 N. Cockrell Hill Road **Job Summary:**As a Cook at Red Lobster, you will be responsible for ensuring the highest quality of food preparation and presentation.**Key Responsibilities:*** Set up and stock prep and line stations to ensure efficient food preparation and service* Clean, sanitize, and organize the kitchen area, equipment, and...

  • Housekeeping Specialist

    3 weeks ago

    Duncanville, Texas, United States Healthcare Services Group, Inc. Full time

    About UsHealthcare Services Group, Inc. is a leading provider of housekeeping, laundry, dining, and nutritional services within the healthcare market. With over 45 years of experience, we have established ourselves as a trusted partner for thousands of healthcare communities across the country.Our Purpose and ValuesWe are committed to fostering fulfillment...

  • Radiologic Technologist Position

    4 weeks ago

    Duncanville, Texas, United States MLee Healthcare Staffing and Recruiting, Inc Full time

    Diagnostic Imaging SpecialistMLee Healthcare Staffing and Recruiting, Inc is seeking a skilled and ARRT-certified Radiologic Technologist (Rad Tech) to join our esteemed healthcare team near Dallas, TX.Key Responsibilities:Schedule: Mon-Fri 3pm-11pm, Mon-Thu 7:30pm-6am or Sat-Mon 7am-7:30pmPerform a variety of diagnostic imaging procedures, including X-rays,...

  • Dental Hygiene Specialist

    4 weeks ago

    Duncanville, Texas, United States KAD Full time

    Job Opportunity at KAD**Job Summary**KAD is seeking a highly skilled and dedicated Registered Dental Hygienist to join our team in Duncanville. As a key member of our pediatric practice, you will play a vital role in providing exceptional patient care and contributing to the success of our team.**Responsibilities**• Provide high-quality dental hygiene...

  • Radiation Therapist

    1 month ago

    Duncanville, Texas, United States Baylor Scott & White Health Full time

    Job SummaryThe Radiation Therapist, under the general supervision of a Radiation Oncologist, performs radiation therapy procedures on ambulatory and hospital patients as requested by a physician or other licensed provider for the diagnosis of disease and injury in accordance with established protocols.Key ResponsibilitiesPerforms high-quality radiation...

  • Commercial Relationship Specialist

    4 weeks ago

    Duncanville, Texas, United States Frost Bank Full time

    About the RoleFrost Bank is seeking a skilled Relationship Manager II to join our team. As a key member of our commercial banking team, you will be responsible for building and maintaining strong relationships with our commercial customers, providing exceptional customer service, and driving business growth.Key ResponsibilitiesDevelop and maintain a...

  • Radiation Therapist

    3 weeks ago

    Duncanville, Texas, United States Baylor Scott & White Health Full time

    About the RoleWe are seeking a skilled Radiation Therapist to join our team at Baylor Scott & White Health. As a Radiation Therapist, you will play a critical role in delivering high-quality patient care and contributing to the success of our cancer treatment programs.Key ResponsibilitiesPerform radiation therapy procedures on ambulatory and hospital...

  • Probate Litigation Support Specialist

    7 days ago

    Duncanville, Texas, United States Gpac Full time

    Probate Litigation Legal AssistantOur client, a renowned law firm, is seeking a detail-oriented and organized Probate Litigation Legal Assistant to support their trust and probate litigation practice in Dallas. This is an exceptional opportunity for an experienced professional to work in a collaborative and professional environment, providing top-tier legal...

  • Radiologic Technologist

    1 month ago

    Duncanville, Texas, United States MLee Healthcare Staffing and Recruiting, Inc Full time

    Job SummaryMLee Healthcare Staffing and Recruiting, Inc is seeking a skilled and ARRT-certified Radiologic Technologist to join our esteemed healthcare team.Key Responsibilities:Schedule: Mon-Fri 3pm-11pm, Mon-Thu 7:30pm-6am or Sat-Mon 7am-7:30pmPerform Diagnostic Imaging Procedures: Conduct a variety of diagnostic imaging procedures, including X-rays,...

  • Physical Therapist

    4 weeks ago

    Duncanville, Texas, United States Enhabit Home Health & Hospice Full time

    Physical Therapist Job Description Overview At Enhabit Home Health & Hospice, we're committed to delivering exceptional patient care in the comfort of their own homes. As a Physical Therapist, you'll play a vital role in helping our patients regain mobility and independence. Responsibilities As a Physical Therapist, you'll be responsible for: *...

  • Physical Therapist

    4 weeks ago

    Duncanville, Texas, United States PARS Therapy Full time

    About the RoleWe are seeking a skilled Physical Therapist to join our team at PARS Therapy in Duncanville, TX. As a PRN Physical Therapist, you will play a vital role in providing high-quality patient care and promoting optimal mobility and function.Key ResponsibilitiesDevelop and implement personalized treatment plans to meet patients' unique needs and...

  • Physical Therapist

    1 month ago

    Duncanville, Texas, United States Enhabit Home Health & Hospice Full time

    {"Job OverviewAt Enhabit Home Health & Hospice, we're dedicated to providing exceptional care to our patients in the comfort of their own homes. As a Physical Therapist, you'll play a vital role in helping our patients regain their independence and improve their quality of life.We're committed to fostering a collaborative and innovative work environment that...

  • Physical Therapist

    4 weeks ago

    Duncanville, Texas, United States PARS Therapy Full time

    About the RoleWe are seeking a skilled Physical Therapist to join our team at PARS Therapy in Duncanville, TX. As a PRN Physical Therapist, you will play a vital role in providing high-quality patient care and promoting optimal mobility and function.Key ResponsibilitiesDevelop and implement personalized treatment plans to meet patients' unique needs and...

  • Pediatric Physical Therapist

    4 weeks ago

    Duncanville, Texas, United States Aveanna Full time

    Pediatric Physical Therapist Job DescriptionAveanna is seeking a compassionate and skilled Pediatric Physical Therapist to join our team in providing high-quality care to our pediatric patients in the comfort of their own homes.Job Summary:We are looking for a dedicated and experienced Physical Therapist to work with our pediatric patients in a home health...