QA Associate - IDAP, 3rd Shift

About the Role

Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, and organizational SOPs. This role supports the development of the organization’s Quality Mindset, fostering a culture of efficiency, attention to detail, and on-time delivery. The QA Associate will identify operational and quality gaps, exemplify excellent interpersonal skills, and build productive, customer-centric relationships with colleagues and partners. Strong written and oral communication skills are essential for articulating complex issues to diverse audiences. The role requires thriving in a team environment while also working autonomously with strong self-management and organizational skills. The QA Associate will influence positive outcomes without direct reporting authority and value process owners and subject matter experts.

Responsibilities

• Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor.
• Review and approve documentation for Quality approval, including batch records, logbooks, work orders, and procedures.
• Collaborate with the Manufacturing/Operations team to lead or support investigations into equipment and process-related deviations.
• Support other QA personnel with batch record reviews and material release.
• Prioritize and balance production timelines with product quality assurances.
• Exercise rapid decision-making in evaluating the scope and impact of deviations, product segregation requirements, and implementation of initial corrective actions or escalate issues to management.
• Provide cross-functional support in deviation investigative processes using root cause analysis tools, report writing, and mitigation development with risk analysis tools.
• Exemplify and enforce safety expectations, positive intervention, and best practices aligned with SOPs, compliance requirements, and site goals.
• Utilize paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software) to ensure data integrity for site policies, procedures, and batch records.
• Apply technical skills and statistics to analyze and track deviations and identify sources of variability and error in site processes.
• Manage multiple projects in a fast-paced environment.

Requirements

• Bachelor’s Degree required (preferred in Science: Chemistry, Biology, Biochemistry, Microbiology, or related field).
• Minimum of 2 years of experience working in Quality in a GMP Manufacturing environment and/or as an Operator within a Pharmaceutical Manufacturing environment.
• Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.
• Understanding of Good Documentation Practices (GDPs) and their criticality.
• Visual acuity of 20/20 or better, with or without corrective lenses, and color vision.
• Excellent written and verbal communication skills.
• General computer skills, including hands-on experience with computerized Operations equipment (SCADA) and reporting/data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).

Preferred Qualifications

• Hands-on experience with aseptic manufacturing, inspecting finished products, and Acceptable Quality Limits (AQLs).
• Experience with Continuous Improvement, Six Sigma, and/or Lean principles.

Schedule

This position primarily supports third shift (11:00 PM – 7:30 AM) with occasional weekend support, dependent on operational needs.

About the Company

At INCOG BioPharma Services, we have built a world-class CDMO for parenteral injectable drugs. Our culture prioritizes long-term value for customers through a service-oriented mindset, technical excellence, and a collaborative, team-centered approach. We are committed to ensuring quality outcomes and accelerating our customers' route to market. All positions are based in Fishers, IN, and our campus is smoke-free.