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Quality Specialist (GMP Facility)
Rutgers University in New Brunswick, New Jersey
 
 
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Date Posted 05/26/2022
Category
Admin-Facilities Management
Employment Type
Application Deadline Open until filled
 
 
 
 
 

Position Details
Position Information


Recruitment/Posting Title Quality Specialist (GMP Facility)
Job Category Staff & Executive - Other
Department Cancer Institute of New Jersey
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 Specialist (GMP Facility) for the Office of Human Research Services within the Rutgers Cancer Institute of New Jersey. Under direction, the Quality Specialist will be responsible for overseeing all aspects of quality control system and in-house quality control procedures, staff training and critical production steps of the GMP Facility, and development of new procedures improving clinical production and proper documentation of manufacturing activities. The Quality Specialist participates in all activities required for proper maintenance of the quality assurance and quality control system. The Quality Specialist may be required to assist the GMP Manufacturing team with manufacturing activities, on an as needed basis.
Among the key duties of this position are the following:
  • Works closely with the QA Manager in the development, revision, implementation, and maintenance of standard operating procedures (SOPs) according to good manufacturing practices (GMP) and FDA approved guidelines for the GMP Facility.
  • Works closely with the QA Manager in preparing the GMP Facility for internal or external audits and inspections by any authorized agencies including FDA.
  • Oversees and assists with validation testing.
  • Oversees and assists with shipment of test samples to external testing sources and acquisition of test reports.
  • Oversees and assists with collection of the QC test documentation received from outside testing laboratories and collaborators that is used to certify and qualify the products received, stored, and generated by GMP Facility for clinical use.
  • Reviews batch records to ascertain timely data entries and accuracy of the procedures performed in accordance with the current SOPs approved for the GMP Facility activities.
Position Status Full Time
Hours Per Week
Daily Work Shift
FLSA Exempt
Grade 26S
Position Salary
Annual Minimum Salary 67982.000
Annual Mid Range Salary 81682.000
Annual Maximum Salary 97056.000
Standard Hours 37.50
Union Description HPAE, Local 5094
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

Under Policy 60.1.35 , Rutgers University requires all prospective 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 individual a medical or religious exemption. Prospective employees who are not eligible for a booster at the time of an offer of employment must provide proof they have received a booster within two weeks (14 calendar days) of eligibility . Based on current guidance, individuals are considered fully vaccinated against COVID-19 two weeks after receiving the final dose of any COVID-19 vaccine authorized or approved for use in the United States by the United States Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC). 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 prospective employee’s offer of employment and/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 a related field with five years of experience in cell therapies.
Certifications/Licenses
Required Knowledge, Skills, and Abilities
  • Effective oral and written communication skills.
  • Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access, and PowerPoint.
Preferred Qualifications
  • Master’s degree in a related field with three years of experience within a quality role.
Equipment Utilized
Physical Demands and Work Environment
  • Must meet minimum vision requirements.
  • Lifting up to 25 lbs.
Special Conditions

Posting Details


Posting Number 22ST0363
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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