Quality Assurance Data Review Specialist

2 weeks ago

Fishers, United States INCOG BioPharma Services Full time

Quality Assurance Data Review Specialist


INCOG Biopharma Services in Indianapolis, IN is hiring a Quality Assurance Data Review Specialist. They are seeking a highly motivated and detail-oriented individual who will review and approve Quality Control documentation, ensuring the highest quality products for their clients.


This role is a great opportunity to work with Quality Control personnel but within the realm of the Quality Assurance department. The candidate will have the opportunity to learn about the equipment used to perform testing as well as the different methods for performing each test. The ideal candidate will be able to communicate with the other data reviewers to ensure adherence to quality standards.


The Quality Assurance Data Review Specialist is responsible for reviewing and approving Quality Control documentation. This documentation includes all Quality Control Chemistry and Quality Control Microbiology data. The Data Review Specialist will work in coordination with the Quality Assurance Technical Manager to perform periodic walkthroughs of the Quality Control laboratories to ensure good laboratory practices are followed and the areas meet regulatory inspection readiness.


There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.


At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.


Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG’s clients.


Job Functions:


  • Perform laboratory data review processes for incoming materials, in-process, finished product, and stability testing from QC Chemistry and QC Microbiology.
  • Partner with Quality Control in the data analysis, and data review process.
  • Establish an ongoing state of readiness in the exercising of rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions.
  • In co-ordination with QC management, use knowledge of quality principles, cGMPs, and regulatory standards to maintain a state of constant inspection-readiness in the QC laboratories.
  • Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, etc.) to ensure data integrity for all Quality Assurance and Quality Control site policies, procedures, and testing records.
  • Use technical skills and applied statistics to analyze and track laboratory investigations and to identify sources of variability and error in QC processes. Use data trends to apply a systematic approach to resolve technical issues, prevent errors, identify improvement opportunities, and implement continuous improvement plans.


Candidate Requirements:


  • Bachelor’s Degree, preferred to be in Science (Chemistry, Biology, or Biochemistry); advanced degree preferred.
  • 2+ years of biopharma industry experience, with at least 1 year of hands-on experience with isolator-based aseptic manufacturing Quality required.
  • Demonstrated history of excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences.


Why INCOG?


  • Paid time off, based on tenure
  • 11 paid holidays
  • 401(k) plan with company match up, vested immediately
  • Choice of health & wellness plans
  • FSA and HSA options
  • Onsite wellness facility
  • Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

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