QUALITY SYSTEMS ANALYST
Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply for this Job link/button.
If you would like to bookmark this position for later review, click on the Bookmark link. If you would like to print a copy of this position for your records, click on the Print Preview link.
Bookmark this Posting |
Print Preview |
Apply for this Job
Posted Job Title
QUALITY SYSTEMS ANALYST
Perelman School of Medicine
Posted to the Web
Posted Job/Salary Grade
8am to 5 pm
Contingent Upon Funding
Position End Date
The Quality Systems (QS) Analyst will support early phase I cell and gene therapy clinical trials in cancer and HIV, by ensuring Good Manufacturing Practice (GMP) compliance for all products manufactured at the Clinical Cell and Vaccine Production Facility (CVPF). The QS Analyst will work within the Quality Assurance function of the Clinical Cell and Vaccine Production Facility (CVPF) for the assurance of batch record quality and compliance. The individuals primary responsibility will be the coordination and review of manufacturing and testing records for designated clinical trials. Overall coordination and review includes but is not limited to the following tasks: (1) Review of all in process manufacturing records and other documentation by verifying calculations, unique identifiers, and ensuring that all Standard Operating Procedures were followed during the manufacturing process; (2) Preparation of final release documentation and preparation of final product labels; (3) Effectively communicate with Manufacturing staff to clarify/resolve discrepancies found during record review; (4) Ensure initiation of deviation investigations and proper documentation for deviations that occur during manufacturing and/or release testing; (5) coordinating the completion of batch record review for Director review and QA release. The QS Analyst will also assist in the electronic capture, mining and trending of manufacturing and quality control testing data and may also review usage logs, and environmental monitoring reports. The QS Analyst will be responsible for other duties as assigned. Weekend work may be required, due to the clinical manufacture schedule.
Required: A Bachelors degree in a science-related discipline and a minimum of three years of quality or analytical experience in an FDA regulated environment. A combination of education and related work experience will be considered. Demonstrated experience in product batch record review according to cGMP guidelines, writing/revising SOPs, addressing Corrective and Preventative Actions, HIPAA requirements. Individuals with sharp attention to detail with a strong background in medical terminology. Exceptional organizational skills and expertise in navigating Microsoft Excel. Friendly demeanor and ability get along and maintain productivity within cross-functional groups. Preferred: Demonstrated experience working under deadlines. Broad working knowledge of cellular therapy, working knowledge of immunology, including immune function and molecular biology release tests including ELISAs, flow cytometry, PCR-based assays, sterility testing. Knowledge of 21CFR Part 11
Affirmative Action Statement
Background Check Required
http://jobs. hr. upenn. edu/postings/7366
Posting Supplemental Questions
Required fields are indicated with an asterisk (*).
How did you hear about this employment opportunity?
+ 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
+ Indeed. com
+ Other Internet Advertisement
+ Other Social Media Site
+ Professional Affiliation/Trade Website
+ Diversity Association/Publication Website
+ Heard about it at a conference or career fair
What is your highest level of education?
+ 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
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
A background check may be required for this position. Do you agree to allow a background check to be performed as a condition of employment?
Do you have analytical experience in an FDA regulated environment?
Do you have experience with product batch record review according to cGMP guidelines?
Do you have experience writing/revising SOPs and addressing Corrective and Preventative Actions?
What is your experience level with Microsoft Excel?
Start Your Job Application
Free Email Job Alerts
Have the latest jobs
delivered to your Inbox.
Thank you for signing up for Email Job Alerts