Posting Details

Posting Details

Reference Number 40-27184
School Name Perelman School of Medicine
Org PA-Pathology Bioresource
Posted to the Web 03/23/2018
Posted Job/Salary Grade 023
Employment Type Non-Exempt
Hours 40.00
Position Type Full Time
Position Schedule 8-5pm
Months 12
Position Length Contingent Upon Funding
Position End Date
University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

School/Center Overview

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education.


The Quality Assurance Records Management Associate will work within the Quality Assurance function if the Clinical Cell and Vaccine Production Facility (CVPF) to support clinical trials in HIV and oncology. The individual’s primary responsibilities are the management and coordination of key Records Management/QA activities such as

* Maintain updated Master Batch Records and Issue Batch Production Records (daily)
* Scan released product binders to shared drive; maintain updated tracker (daily)
* Copy and file reviewed records and assay results; scan reviewed documents to inter-departmental teams as needed
* Coordinate Records Management activities by identifying and collecting documents that can be stored off-site; pack, assign box numbers, creates lists, update tracker and coordinate pick-up
* Maintain updated records of documents stored onsite and offsite locations
* Serve as a back-up contact for controlled document management and training records
* Support the Training Program by being able to create, assign, monitor, and manage training items and metrics
* Support the QA Ops team by issuing Harvest Labels, when needed.


A High School diploma and 1-3 years of related experience, or an equivalent combination of education and experience, in a controlled document organization are required. Ability to multi-task. Detailed-oriented with strong Microsoft Office and Customer Service skills. Excellent time management and organizational skills in combination with the ability to prioritize task and meet deadlines are required to excel in this position. Demonstrated ability to interact professionally with individuals of varying levels of education, experience, and job duties is required. Willingness to work extended hours/schedules as needed.

Preferred: Prior training and experience with HIPAA, GLP or GMP strongly preferred. Background in medical or scientific terminology is preferred.

Affirmative Action Statement

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements
Quick Link

Posting Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * How did you hear about this employment opportunity?
    • Jobs@Penn
    • Contacted by a Penn Recruiter
    • Referred by a Penn Employee
    • Referred by a friend or family member
    • Higher Education Recruitment Consortium (HERC)
    • Inside Higher Ed
    • Other Internet Advertisement
    • Linkedin
    • Twitter
    • Other Social Media Site
    • Professional Affiliation/Trade Website
    • Diversity Association/Publication Website
    • Heard about it at a conference or career fair
    • Apple One
    • Recruitment and/or staffing agency
  2. * What is your highest level of education completed?
    • Less than high school education
    • High School Diploma or GED
    • Vocational or Technical School
    • Associate's Degree or Two Year College
    • Bachelor's Degree
    • Master's Degree
    • PHD/MD/JD or equivalent doctoral degree
  3. * How many years of experience do you have related to this position?
    • 0 to 1 Year
    • 1 to 2 Years
    • 2 to 3 Years
    • 3 to 5 Years
    • 5 to 7 Years
    • 7 to 10 Years
    • Over 10 Years
  4. * Are you willing to work extended hours/schedules as needed?
    • Yes
    • No
  5. * Please describe your experience handling controlled records (manufacturing batch records, SOPs, etc.) with minimal supervision. This includes identifying priorities and time management. Select the one that best applies to you.
    • Novice (I have little or no previous experience – My related experience is between 0-1 years)
    • Somewhat Experienced (I can do the job somewhat independently – My related experience is between 1-3 years)
    • Expert (I can manage the Records Management program with little or no supervision. I can also identify areas of improvement and execute
  6. * As it pertains to Records Management, have you worked writing SOPs/forms and other type of controlled documents? Select the one that best applies to you.
    • Novice (I have little or no previous experience – My related experience is between 0-1 years)
    • Somewhat Experienced (if assigned to write and SOP I can do the job independently – My related experience is between 1-3 years)
    • Expert (I can write SOPs including the change control, putting together the action plan, writing the final report, etc - My related experience is between 3-5 years or above)
  7. * What is you level of expertise using Microsoft Suite (Excel, Word, and Power Point?) This includes using Access database. Select the one that best applies to you.
    • Novice (I have little or no previous experience. I don’t know how to work with Excel spreadsheets but I can learn quickly)
    • Somewhat Experienced (I have basic knowledge and experience using Microsoft applications to create and edit documents. My related experience is between 1-3 years.)
    • Expert (I have training, vast knowledge and experience using Microsoft applications to create, edit, reformat, filter and protect documents.)
  8. * What is your level of expertise in terms of HIPAA, GLP and cGMPs and working in a GMP environment? Select the one that best applies to you.
    • None (I no expertise. I have not worked in a GMP environment before)
    • Novice (My summed up experience working in a GMP environment is between 0-1 years. I have basic knowledge of HIPAA, GLP, and cGMPs).
    • Somewhat Experienced (My summed up experience working in a GMP environment is between 1-3 years).
    • Expert (My summed up experience working in a GMP environment is between 3-5 years or above. I could help with Continuous Improvement initiatives).

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter