QA Data Review Specialist, 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 Quality Assurance Data Review Specialist is responsible for reviewing and approving Quality Control documentation. This documentation includes all Quality Control Chemistry, Quality Control Microbiology and Incoming Quality Control 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.  This is a 2nd Shift Position.  Essential 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 identify sources of variability and error in QC processes.  

Special Job Requirements:

• Bachelor’s Degree required in Science (Chemistry, Biology, Microbiology or Biochemistry).  
• Minimum of 3 years’ experience of GMP biopharma industry experience, with at least 1 year experience with isolator-based aseptic manufacturing environments required. 
• 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.   
• Exemplifies excellent interpersonal skills and can develop productive working relationships with colleagues, customers, suppliers, and partners. Demonstrated ability to influence positive outcomes without direct reporting authority. 
• Demonstrates excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. 
• Commits to a culture of quality with skills including attention to detail, on time delivery, and efficiency. 
• Upholds customer-centric mindset. 

Additional Preferences:

• 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. 
  

Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.   If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.  INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.  By submitting your resume and details, you are declaring that the information is correct and accurate.