QA Data Review Specialist, 2nd shift

INCOG BioPharma Services • Fishers, IN

1d • Onsite

About The Position

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.

Requirements

• Bachelor’s Degree required
• Minimum of 2+ years of biopharma industry experience
• At least 1 year of hands-on experience with isolator-based aseptic manufacturing Quality required
• 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.
• Thrives in a team environment but can work autonomously with strong self-management and organizational skills.
• Commits to a culture of quality with skills including attention to detail, on time delivery, and efficiency.
• Upholds customer-centric mindset.

Nice To Haves

• Degree preferred to be in Science (Chemistry, Biology, or Biochemistry)
• Advanced degree preferred

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level