BaltimoreRecruiter Since 2001
the smart solution for Baltimore jobs

Quality Control Data Reviewer

Company: Paragon BioServices, Inc.
Location: Baltimore
Posted on: June 15, 2019

Job Description:

Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Key Responsibilities include but are not limited to:

  • Receive Batch Records from other departments
  • Receive and organize completed test results
  • Perform detailed data review for test results on assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC, Capillary Electrophoresis, Bioburden, endotoxin, TOC, and membrane filtration testing, generated by QC department for compliance with cGMP, internal SOPs and Specifications to support production, stability studies and lab operation
  • Review release and stability data, trend charts of reference standards, lab equipment calibration records and log-books and other review function as needed
  • Perform detailed data review for analytical test results generated by contract testing labs to assure their correctness and accuracy
  • Work with analysts to complete any corrections to data notebooks
  • Compile data results in accordance to SOPs and QC best practices
  • Maintain and update relevant SOPs for data review and reporting as needed
  • Ensure that suitable written records and work undertaken are kept in accord with cGMP and company procedures
  • Receive and organize completed Test Records
  • Pairing of completed Test Records with Batch Records
  • Respond to other department inquiries regarding status of results Experience & Education:
    • Associates degree required; Bachelor degree preferred with 2 or more years of experience reviewing Quality Control data for cGMP compliance.
    • Prior experience running cell based/protein analytical assays in a cGMP Quality Control lab required
    • Strong attention to detail and strong organizational skills Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1

Keywords: Paragon BioServices, Inc., Baltimore , Quality Control Data Reviewer, Other , Baltimore, Maryland

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Work From Home!
Description: We are looking for people that enjoy working with other people. If you have an upbeat personality and like to help people, you will have tremendous success with our company.
Company: Garcia Healthcare
Location: Chantilly
Posted on: 06/27/2019

Systems Engineer (Mid) - TS/SCI w/ Poly Required
Description: Job Description: br br The successful candidate will work as an Engineer in a collaborative team-focused environment. The candidate will be responsible in the evaluation and integration of commercial (more...)
Company: Leidos
Location: Chantilly
Posted on: 06/27/2019

Network and IT System Engineer
Description: Job Description: br br The Leidos Defense Intelligence Group has a current opening for a Network and IT System Engineer supporting the U.S. Government in a challenging, dynamic setting located (more...)
Company: Leidos
Location: Chantilly
Posted on: 06/27/2019


Truck Driver - Home Weekly - Average $75k+/Year - No Touch Freight - Lancaster
Description: Miller is Now Hiring Local Dedicated CDL-A DriversAverage 75k per Year - No-Touch FreightMiller Dedicated
Company: Miller - Leesport, PA
Location: Lancaster
Posted on: 06/27/2019

Solutions Architect / Systems Engineer - TS/SCI w/ Poly Required
Description: Job Description: br br Seeking a Systems Engineer. The candidate will assist the PMO with administrative tasks, help with developing innovative concepts and solutions across the program, and work (more...)
Company: Leidos
Location: Chantilly
Posted on: 06/27/2019

Travel Nurse - Step Down RN - Leesburg, VA
Description: Want to spend summer 45 minutes from Bush Gardens in Williamsburg VA, Step Down Registered Nurse RN needed in Leesburg VA br Start your next travel opportunity with this great Registered Nurse RN (more...)
Company: General Healthcare Resources - Travel Nursing
Location: Leesburg
Posted on: 06/27/2019

Watch Administrator
Description: Job Description:This position is for a 12 hour shift 6 AM to 6 PM OR 6PM to 6AM, 3/4 days per week, including weekends and holidays . This position will provide technical support to mission-targeted (more...)
Company: Leidos
Location: Chantilly
Posted on: 06/27/2019

Peoplesoft HCM
Description: Peoplesoft HCM Location Chantilly,
Company: Accuro Group
Location: Chantilly
Posted on: 06/27/2019

SIGINT/GIS- TS/SCI w/ Polygraph
Description: Job Description: br br The Intelligence Group at Leidos is currently seeking an All-Source Targeter/Analyst for an Intelligence Community customer. The successful candidate will work as a member (more...)
Company: Leidos
Location: Chantilly
Posted on: 06/27/2019

CLEANER
Description: ABM, a leading provider of integrated facility solutions, is looking for a Cleaner. The Cleaner provides the
Company: ABM Industries
Location: Lancaster
Posted on: 06/27/2019

Log In or Create An Account

Get the latest Maryland jobs by following @recnetMD on Twitter!

Baltimore RSS job feeds