Quality Assurance Data Review Specialist

Quality Assurance Data Review Specialist

INCOG Biopharma Services in Indianapolis, IN is hiring a Quality Assurance Data Review Specialist to join their 2nd shift. 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 QA Data Review Specialist is responsible for reviewing and approving QC documentation. This documentation includes all QC Chemistry, QC Microbiology and Incoming QC data. The Data Review Specialist will work in coordination with the QA Technical Manager to perform periodic walkthroughs of the QC 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 INCOG’s clients.

Job Functions:

• This is a 2nd shift position: 3pm - 11:30pm Monday to Friday.
• 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 identify sources of variability and error in QC processes.

Candidate Requirements:

• Bachelor’s Degree required in Science (Chemistry, Biology, Microbiology or Biochemistry).
• At least 3 years’ experience of GMP biopharma industry experience, with at least 1 year experience with isolator-based aseptic manufacturing environments preferred.
• Experience as a technical data reviewer in a GMP regulated industry.
• High level of understanding and oversight of Quality Control testing processes in both QC Chemistry and QC Microbiology for aseptic manufacturing.
• Thrives in a team environment but can work autonomously with strong self management and organizational skills.
• Ability to handle a variety of tasks in a timely fashion.

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