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Quality Manager (Quality Assurance of GMP Facility)
Rutgers University in New Brunswick, New Jersey
 
 
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Date Posted 05/11/2022
Category
Admin-Facilities Management
Employment Type
Application Deadline Open until filled
 
 
 
 
 

Position Details
Position Information


Recruitment/Posting Title Quality Manager (Quality Assurance of GMP Facility)
Job Category Staff & Executive - Healthcare - Other
Department CINJ-OHRS Quality Assurance
Overview
Our vision is to be a statewide, national and world leader of scientific discovery, transdisciplinary engagement, translation, patient care and education that improves outcomes for cancer patients and populations.
We will accomplish this by conducting innovative basic, clinical and population research and cutting-edge patient-centered care that expands our understanding of the etiology and biology of cancer; facilitates the rapid translation of laboratory-based discoveries into human studies; develops new approaches and interventions for cancer prevention that decrease cancer incidence and mortality; and develops new and better therapies to decrease suffering and mortality from cancer.
Curiosity and Discovery, Integrity, Collaboration, Respect and Caring, Perseverance.
Posting Summary
Rutgers, The State University of New Jersey is seeking a Quality Manager (Quality Assurance of GMP Facility) in Clinical Research Enterprise at Rutgers Cancer Institute of New Jersey.
The Manager, Quality Assurance Unit is responsible for ensuring the quality and safety of engineered T cell therapy and other products and services provided by GMP Facility by applying expert knowledge of quality principles and practices to the design, implementation, control, monitoring, assessment, and continuous improvement of GMP work processes. This role is responsible for overseeing and approving the design, development, implementation, and management of the quality management system for the GMP Facility. The QA Manager will lead QA related projects and serve as an expert resource, providing quality oversight and ensuring regulatory and accreditation compliance for cellular therapy products manufacturing and distribution, laboratory services, and general support functions such as information systems, facilities and safety related to the Cell Therapy Program. The QA Manager will personally participate in execution of QA/QC activities for the GMP Facility as needed.
Among the key duties of this position are the following:
  • Develops Quality Management Program for Cell Therapy Program at CINJ.
  • Develops and maintains all of GMP required documentation (including SOPs, controlled forms for manufacturing, personnel training, GMP facility use and maintenance, equipment maintenance, reagents validation, deviations, CAPAs etc).
  • Approves the design and oversees the implementation of GMP Facility quality management system, including development, improvement and review of related SOPs, processes, IT solutions, and quality tools.
  • Monitors and arranges timely equipment preventive maintenance, services, calibration, certification.
  • Monitors and arranges timely facility cleaning.
  • Creates, maintains and revises all controlled documents for GMP Facility as required.
  • Monitors all systems in the Facility for their performance status.
  • Ascertains proper structure and function of all elements of GMP suite.
  • Assists with development and validation of the Quality Control Tests for in-process and final product testing as well as for demonstration of the proper functioning of the equipment.
Position Status Full Time
Hours Per Week
Daily Work Shift
FLSA Exempt
Grade 30S
Position Salary
Annual Minimum Salary 91501.000
Annual Mid Range Salary 115747.000
Annual Maximum Salary 139995.000
Standard Hours 37.50
Union Description Non-Union
Payroll Designation PeopleSoft
Benefits
Rutgers offers a comprehensive benefit program to eligible employees. For details, please go to http://uhr.rutgers.edu/benefits/benefits-overview .
Rutgers also offers a benefit program to eligible full-time postdoctoral fellow students. For details, please go to https://finance.rutgers.edu/healthcare-risk/insurance/postdoctoral-health-insurance.
COVID-19 Immunization Requirement

Rutgers University requires all new employees to provide proof that they are fully vaccinated and have received a booster (where eligible) against COVID-19 prior to commencement of employment, unless the University has granted the employee a medical or religious exemption. Employees who are not eligible for a booster at the time of an offer of employment provide proof they have received a booster upon eligibility and upload proof of same. Based on current guidance, individuals are considered fully vaccinated against COVID-19 two weeks after receiving the final dose of a vaccine approved or authorized for emergency use in the United States or a vaccine that has been listed for emergency use by the World Health Organization. Eligibility for a booster against COVID-19 varies and is explained on the University’s web site located at https://coronavirus.rutgers.edu/covid-19-vaccine . Failure to provide proof of primary vaccination and booster will result in rescission of a candidate’s offer of employment or disciplinary action up to and including termination.

Seniority Unit
Terms of Appointment Staff - 12 month
Position Pension Eligibility ABP

Qualifications


Minimum Education and Experience
  • Bachelor’s degree in life sciences, pharmaceutical, biotech or biologics manufacturing, or quality management.
  • Equivalent experience, education and/or training may be substituted for the education requirements.
  • Minimum seven years specialized experience (includes performing activities of a quality professional in a healthcare or drugs/biologics/medical devices GMP manufacturing setting or as an auditor of the regulatory agencies such as FDA, FACT etc.).
  • Minimum ten years total relevant experience (includes any combination of: 1) specialized experience described above, and 2) clinical or technical work performed in a healthcare, laboratory, or drugs/biologics/medical devices GMP manufacturing setting).
  • Minimum five years management experience (includes supervision of Quality Assurance activities) or oversight, management or consulting services for the new development and implementation of the GMP units.
Certifications/Licenses
Required Knowledge, Skills, and Abilities
  • Broad knowledge of quality assurance methods, principles, and practices, including basic statistical analysis and sampling techniques, auditing, process control, validation, and process improvement methodologies.
  • Expert knowledge of regulations and accreditation standards applicable to cGMP facility and cell therapy program.
  • Strong work knowledges of quality system and regulatory requirements (21 CRF Part 11/210/211, 21 CFR 1271, ICH 8, ICH 9, ICH 10) in both U.S. and E.U. id.
  • Effective oral and communication skills.
  • Expert ability to apply knowledge of, and interpret applicable Federal, State, Local and international regulations and standards, technical specifications, and other guidelines to evaluate compliance.
  • Expert ability to analyze and interpret observational, operational, and quality data to monitor process performance and to determine if products and services are performing within defined specifications.
  • Expert ability to conduct studies and investigations for problem analysis, and risk assessments to assist with development of logical and well-documented recommendations for process improvement and corrective actions.
  • Highly proficient at preparing and delivering clear, concise, and effective written and oral communications.
  • Highly proficient at establishing effective interpersonal relationships to meet the goals of the organization.
  • Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint.
Preferred Qualifications
  • Familiarity with FACT (Foundation for the Accreditation of Cellular Therapy) Accreditation Standards.
Equipment Utilized
Physical Demands and Work Environment
PHYSICAL DEMANDS: Standing, sitting, walking, talking and hearing. No special vision requirements. Lifting up to 25 lbs. 
WORK ENVIRONMENT: Laboratory environment. Exposure to blood or other body fluids. Exposure to hazardous chemicals. Moderate noise.
Special Conditions

Posting Details


Posting Number 22ST0016
Posting Open Date
Special Instructions to Applicants
Regional Campus Rutgers Biomedical and Health Sciences (RBHS)
Home Location Campus Downtown New Brunswick
Location Details
New Brunswick, New Jersey

Pre-employment Screenings


All offers of employment are contingent upon successful completion of all pre-employment screenings.



Infection Control and Safety


This position is subject to all Rutgers University policies, including TB surveillance and other infection control and safety policies. Please review the Tuberculosis Surveillance Policy for additional information.



Affirmative Action/Equal Employment Opportunity Statement


It is university policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, affectional or sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As an institution, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. For additional information please see the Non-Discrimination Statement at the following web address: http://uhr.rutgers.edu/non-discrimination-statement



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