Senior Quality Assurance Specialist

2 days ago


Indianapolis, Indiana, United States INCOG BioPharma Services Full time
Senior Quality Assurance Specialist

INCOG BioPharma Services is seeking a highly skilled Senior Quality Assurance Specialist to join our team in Indianapolis, IN. As a key member of our Technical Operations team, you will be responsible for ensuring the quality and integrity of our products.

Key Responsibilities:
  • Review and approve documentation for Quality approval, including Technical Transfer risk assessments and summaries, Master Batch Records, Process Performance Qualification protocols and summaries, etc.
  • Collaborate with Manufacturing Sciences & Technology (MSAT) and Manufacturing to ensure product technical transfers and Master Batch Records align with INCOG's manufacturing processes and standards.
  • Represent INCOG Quality Assurance with direct interaction with clients, including weekly project meetings, Technical and QA discussions, reviewing client-provided documents, escorting clients during onsite manufacturing activities as needed, etc.
  • Exercise 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 or escalate the issue to Manager for resolution.
  • Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.
Requirements:
  • Bachelor's Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology, etc.)
  • Minimum of 8 years of experience working in a GMP manufacturing environment
  • Minimum of 4 years experience of QA oversight for GMP manufacturing
  • Experience as performer or reviewer in Quality Management Systems, DMS, Deviation/CAPA, and Change Control required
  • Extensive knowledge of regulations and quality processes involving product disposition
  • Excellent written and verbal communication skills
  • General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.)
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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