Quality Assurance Coordinator (Entry Senior Level) Clinical Immunology
Quality Assurance Coordinator (Entry Senior Level) Clinical Immunology Description University of Colorado Anschutz Medical Campus Department of Medicine Division of Clinical Immunology Official Title:
Research Services Clinical Science Professional (Open Rank:
Entry - Senior) Working Title:
Quality Assurance Coordinator (Open Rank:
Entry - Senior Level) - Clinical Immunology Position:
#00803267 - Requisition:
#29238 Job
Summary:
This is a full time (100% FTE), University Staff (non-classified) Quality Assurance Coordinator position available at ClinImmune Cell & Gene Therapy within the Division of Allergy and Clinical Immunology at the University of Colorado Anschutz Medical Campus.
ClinImmune provides umbilical cord blood and tissue banking, clinical testing for human stem cell and organ transplants, stem cell product processing and infusion services, and histocompatibility and immunogenetics testing for human stem cell & organ transplantation.
ClinImmune is also very involved with gene therapy research and development and flow cytometric testing.
This position is responsible for supporting high level quality and regulatory operations, including research support to the ClinImmune faculty and staff in the areas of training, quality improvement/control, process development and regulatory compliance.
Key Responsibilities Entry Level:
Assist with review, completion, and submission of accreditation application documentation for appropriate regulatory agencies, including FDA (GMP and GTP), ASHI, CAP, AABB, AATB, and FACT.
Assist with submission of annual documentation of facility accreditation.
Must maintain knowledge of current standards, work independently, and with quality manager, to educate and train staff on compliance with all standards.
Assist with organization and review of quality systems including document control, internal and external audits, validations and verifications, IRB applications and continuing review, CAPA documentation and resolution, proficiency testing, and quality improvement.
Participate in audit process for both internal and external entities, including the design and performance of internal audits, scheduling, and coordinating audits, and providing resolution for deficiencies.
Summarize and present audit results at quality review meetings.
Participate in upkeep of document control system, including Master and Archived files.
In addition, review the staff training, annual continuing education requirements, competency, and SOP Reviews.
Perform quality assessment and review of occurrences (CAPA).
Utilize various recording and tracking systems (such as internal databases) to analyze events and determine appropriate resolution with guidance of management.
Provide any necessary follow-up and/or documentation for process change requests and resolution.
Review master batch records, coordinate medical director review of product files, and approve stem cell products for banking and release with guidance from management.
Intermediate Level, all the above and:
Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies that ClinImmune has taken on to assist clinical trials being performed by other University departments or is performing themselves.
Independently perform study related quality processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies.
Assist Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives Act as a Primary Coordinator on multiple projects as assigned by management.
Assist and train junior team members.
Review, complete, and submit accreditation application documentation for appropriate regulatory agencies, including FDA (GMP and GTP), ASHI, CAP, AABB, AATB, and FACT.
Approve and submit annual documentation of facility accreditation.
Must maintain knowledge of current standards, work independently, and with quality manager, to educate and train staff on compliance with all standards.
Organize and review quality systems including document control, internal and external audits, validations and verifications, IRB applications and continuing review, CAPA documentation and resolution, proficiency testing, and quality improvement.
Maintain document control system, including Master and Archived files.
In addition, review the staff training, annual continuing education requirements, competency, and SOP Reviews.
Review master batch records, coordinate medical director review of product files, and approve cell therapy products for infusion.
Senior Level, all the above and:
Assess updates to FDA regulations on human cells, tissues and cellular and tissue-based product (HCT/Ps).
Oversee master clinical trial materials, including but not limited to, protocols, administration manuals, informed consent, communication with sponsors and hospital coordinators, and all other essential study documents for assigned studies.
Create, review, and maintain ClinImmune procedures to align with the current version of all materials.
Develop protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs).
Identify issues related to operational efficiency and shares results with leadership.
Manage audit process for both internal and external audits, including scheduling, coordinating, and providing resolution for deficiencies.
Summarize and present audit results at quality review meetings.
Perform quality assessment and review of occurrences (CAPA).
Verify effectiveness of any corrective and preventative actions.
Determine when an occurrence needs to be reported to the FDA as 3500a or 3486 BPDR.
Why Join Us:
Knowing that, on a daily basis the work performed at ClinImmune not only saves lives, improves the quality of patient's lives and includes highly involved creative thinking to discover and develop cutting edge patient treatments to improve care makes working at ClinImmune highly rewarding.
The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more.
To see what benefits are available, please visit:
https:
//www.
cu.
edu/employee-services/benefits-wellness (https:
//apptrkr.
com/get_redirect.
php?id=4166440&targetURL=https:
//www.
cu.
edu/employee-services/benefits-wellness) Diversity and Equity:
The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty, and administrative staff.
The university strives to promote a culture of inclusiveness, respect, communication and understanding.
We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ
community and all veterans.
The University of Colorado is committed to diversity and equality in education and employment.
Qualifications:
Minimum QualificationsEntry Level:
Bachelor's degree in a science or health-related field.
Intermediate Level:
Bachelor's degree in a science or health-related field.
One (1) year of clinical quality assurance or related experienceSenior Level:
Bachelor's degree in a science or health-related field.
Two (2) years of clinical quality assurance or related experienceA combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
Applicants must meet minimum qualifications at the time of hire.
Preferred QualificationsAll Levels:
One (1) to three (3) years of clinical research or related experience.
Laboratory certification ABHI and/or ASCP (MT or SBB).
Experience with software validations.
Quality Certification.
One (1) year of experience in HLA testing.
Knowledge, Skills, and Abilities Knowledge and understanding of federal regulations on biologics including GTP, GMP, BLA, and IND.
Knowledge and understanding of accrediting agency standards.
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Demonstrated commitment and leadership ability to advance diversity and inclusion.
Knowledge of basic medical terminology.
Ability to interpret and master complex protocols and guidance.
Proficient with Microsoft Excel, Word, and PowerPoint.
Familiar with electronic document control and quality management systems.
How to Apply:
For full consideration, please submit the following document(s):
1.
A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position.
2.
Curriculum vitae / Resume3.
Three to five professional references including name, address, phone number (mobile number if appropriate), and email address.
Questions should be directed to:
Sandra Fradenburg:
email protected (https:
//apptrkr.
com/get_redirect.
php?id=4166440& email protected ) Screening of Applications Begins:
Screening of applications begins immediately and continues until position is filled.
Anticipated Pay Range:
The starting salary range (or hiring range) for this position has been established at the following:
Entry Level:
$44,403 - $56,481Intermediate Level:
$48,321 - $61,464Senior Level:
$52,239 - $66,448The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
This position may be eligible for overtime compensation depending on the level.
Your total compensation goes beyond the number on your paycheck.
The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator:
http:
//www.
cu.
edu@node/153125 (https:
//apptrkr.
com/get_redirect.
php?id=4166440&targetURL=http:
// email protected /153125) ADA Statement:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process.
To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at email protected (https:
//apptrkr.
com/get_redirect.
php?id=4166440& email protected ).
Background Check Statement:
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors.
To assist in achieving that goal, we conduct background investigations for all prospective employees.
Vaccination Statement:
The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date.
Information regarding this requirement, and exemptions can be found at:
Anschutz:
https:
//www.
ucdenver.
edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.
pdf?sfvrsn=4e9df3ba_2 Unit-Specific Exemptions:
Anschutz Campus - Accommodations may be granted for medical or religious reasons.
The University of Colorado seeks individuals with demonstrated commitment to creating an inclusive learning and working environment.
We value the ability to engage effectively with students, faculty, and staff of diverse backgrounds.
Application Materials Required:
Cover Letter, Resume/CV, List of References Job Category:
Research Services Primary Location:
Aurora Department:
U0001 -- DENVER & ANSCHUTZ MED CAMPUS - 20174 - SOM-MED-Clinical Immunology Schedule:
Full-time Posting Date:
Mar 13, 2023 Unposting Date:
Ongoing Posting Contact Name:
Sandra Fradenburg Posting ContactEmail:
email protected (https:
//apptrkr.
com/get_redirect.
php?id=4166440& email protected ) Position Number:
00803267Copyright 2022 Jobelephant.
com Inc.
All rights reserved.
Posted by the FREE value-added recruitment advertising agency (https:
//www.
jobelephant.
com/) jeid-95b5f890f3aaeb459b97a6bbbb367037 Recommended Skills Administration Assessments Auditing Biopharmaceuticals Business Efficiency Cell Therapy Estimated Salary: $20 to $28 per hour based on qualifications.
Research Services Clinical Science Professional (Open Rank:
Entry - Senior) Working Title:
Quality Assurance Coordinator (Open Rank:
Entry - Senior Level) - Clinical Immunology Position:
#00803267 - Requisition:
#29238 Job
Summary:
This is a full time (100% FTE), University Staff (non-classified) Quality Assurance Coordinator position available at ClinImmune Cell & Gene Therapy within the Division of Allergy and Clinical Immunology at the University of Colorado Anschutz Medical Campus.
ClinImmune provides umbilical cord blood and tissue banking, clinical testing for human stem cell and organ transplants, stem cell product processing and infusion services, and histocompatibility and immunogenetics testing for human stem cell & organ transplantation.
ClinImmune is also very involved with gene therapy research and development and flow cytometric testing.
This position is responsible for supporting high level quality and regulatory operations, including research support to the ClinImmune faculty and staff in the areas of training, quality improvement/control, process development and regulatory compliance.
Key Responsibilities Entry Level:
Assist with review, completion, and submission of accreditation application documentation for appropriate regulatory agencies, including FDA (GMP and GTP), ASHI, CAP, AABB, AATB, and FACT.
Assist with submission of annual documentation of facility accreditation.
Must maintain knowledge of current standards, work independently, and with quality manager, to educate and train staff on compliance with all standards.
Assist with organization and review of quality systems including document control, internal and external audits, validations and verifications, IRB applications and continuing review, CAPA documentation and resolution, proficiency testing, and quality improvement.
Participate in audit process for both internal and external entities, including the design and performance of internal audits, scheduling, and coordinating audits, and providing resolution for deficiencies.
Summarize and present audit results at quality review meetings.
Participate in upkeep of document control system, including Master and Archived files.
In addition, review the staff training, annual continuing education requirements, competency, and SOP Reviews.
Perform quality assessment and review of occurrences (CAPA).
Utilize various recording and tracking systems (such as internal databases) to analyze events and determine appropriate resolution with guidance of management.
Provide any necessary follow-up and/or documentation for process change requests and resolution.
Review master batch records, coordinate medical director review of product files, and approve stem cell products for banking and release with guidance from management.
Intermediate Level, all the above and:
Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies that ClinImmune has taken on to assist clinical trials being performed by other University departments or is performing themselves.
Independently perform study related quality processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies.
Assist Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives Act as a Primary Coordinator on multiple projects as assigned by management.
Assist and train junior team members.
Review, complete, and submit accreditation application documentation for appropriate regulatory agencies, including FDA (GMP and GTP), ASHI, CAP, AABB, AATB, and FACT.
Approve and submit annual documentation of facility accreditation.
Must maintain knowledge of current standards, work independently, and with quality manager, to educate and train staff on compliance with all standards.
Organize and review quality systems including document control, internal and external audits, validations and verifications, IRB applications and continuing review, CAPA documentation and resolution, proficiency testing, and quality improvement.
Maintain document control system, including Master and Archived files.
In addition, review the staff training, annual continuing education requirements, competency, and SOP Reviews.
Review master batch records, coordinate medical director review of product files, and approve cell therapy products for infusion.
Senior Level, all the above and:
Assess updates to FDA regulations on human cells, tissues and cellular and tissue-based product (HCT/Ps).
Oversee master clinical trial materials, including but not limited to, protocols, administration manuals, informed consent, communication with sponsors and hospital coordinators, and all other essential study documents for assigned studies.
Create, review, and maintain ClinImmune procedures to align with the current version of all materials.
Develop protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs).
Identify issues related to operational efficiency and shares results with leadership.
Manage audit process for both internal and external audits, including scheduling, coordinating, and providing resolution for deficiencies.
Summarize and present audit results at quality review meetings.
Perform quality assessment and review of occurrences (CAPA).
Verify effectiveness of any corrective and preventative actions.
Determine when an occurrence needs to be reported to the FDA as 3500a or 3486 BPDR.
Why Join Us:
Knowing that, on a daily basis the work performed at ClinImmune not only saves lives, improves the quality of patient's lives and includes highly involved creative thinking to discover and develop cutting edge patient treatments to improve care makes working at ClinImmune highly rewarding.
The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more.
To see what benefits are available, please visit:
https:
//www.
cu.
edu/employee-services/benefits-wellness (https:
//apptrkr.
com/get_redirect.
php?id=4166440&targetURL=https:
//www.
cu.
edu/employee-services/benefits-wellness) Diversity and Equity:
The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty, and administrative staff.
The university strives to promote a culture of inclusiveness, respect, communication and understanding.
We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ
community and all veterans.
The University of Colorado is committed to diversity and equality in education and employment.
Qualifications:
Minimum QualificationsEntry Level:
Bachelor's degree in a science or health-related field.
Intermediate Level:
Bachelor's degree in a science or health-related field.
One (1) year of clinical quality assurance or related experienceSenior Level:
Bachelor's degree in a science or health-related field.
Two (2) years of clinical quality assurance or related experienceA combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
Applicants must meet minimum qualifications at the time of hire.
Preferred QualificationsAll Levels:
One (1) to three (3) years of clinical research or related experience.
Laboratory certification ABHI and/or ASCP (MT or SBB).
Experience with software validations.
Quality Certification.
One (1) year of experience in HLA testing.
Knowledge, Skills, and Abilities Knowledge and understanding of federal regulations on biologics including GTP, GMP, BLA, and IND.
Knowledge and understanding of accrediting agency standards.
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Demonstrated commitment and leadership ability to advance diversity and inclusion.
Knowledge of basic medical terminology.
Ability to interpret and master complex protocols and guidance.
Proficient with Microsoft Excel, Word, and PowerPoint.
Familiar with electronic document control and quality management systems.
How to Apply:
For full consideration, please submit the following document(s):
1.
A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position.
2.
Curriculum vitae / Resume3.
Three to five professional references including name, address, phone number (mobile number if appropriate), and email address.
Questions should be directed to:
Sandra Fradenburg:
email protected (https:
//apptrkr.
com/get_redirect.
php?id=4166440& email protected ) Screening of Applications Begins:
Screening of applications begins immediately and continues until position is filled.
Anticipated Pay Range:
The starting salary range (or hiring range) for this position has been established at the following:
Entry Level:
$44,403 - $56,481Intermediate Level:
$48,321 - $61,464Senior Level:
$52,239 - $66,448The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
This position may be eligible for overtime compensation depending on the level.
Your total compensation goes beyond the number on your paycheck.
The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator:
http:
//www.
cu.
edu@node/153125 (https:
//apptrkr.
com/get_redirect.
php?id=4166440&targetURL=http:
// email protected /153125) ADA Statement:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process.
To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at email protected (https:
//apptrkr.
com/get_redirect.
php?id=4166440& email protected ).
Background Check Statement:
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors.
To assist in achieving that goal, we conduct background investigations for all prospective employees.
Vaccination Statement:
The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date.
Information regarding this requirement, and exemptions can be found at:
Anschutz:
https:
//www.
ucdenver.
edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.
pdf?sfvrsn=4e9df3ba_2 Unit-Specific Exemptions:
Anschutz Campus - Accommodations may be granted for medical or religious reasons.
The University of Colorado seeks individuals with demonstrated commitment to creating an inclusive learning and working environment.
We value the ability to engage effectively with students, faculty, and staff of diverse backgrounds.
Application Materials Required:
Cover Letter, Resume/CV, List of References Job Category:
Research Services Primary Location:
Aurora Department:
U0001 -- DENVER & ANSCHUTZ MED CAMPUS - 20174 - SOM-MED-Clinical Immunology Schedule:
Full-time Posting Date:
Mar 13, 2023 Unposting Date:
Ongoing Posting Contact Name:
Sandra Fradenburg Posting ContactEmail:
email protected (https:
//apptrkr.
com/get_redirect.
php?id=4166440& email protected ) Position Number:
00803267Copyright 2022 Jobelephant.
com Inc.
All rights reserved.
Posted by the FREE value-added recruitment advertising agency (https:
//www.
jobelephant.
com/) jeid-95b5f890f3aaeb459b97a6bbbb367037 Recommended Skills Administration Assessments Auditing Biopharmaceuticals Business Efficiency Cell Therapy Estimated Salary: $20 to $28 per hour based on qualifications.
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