QA Associate - IDAP, 2nd 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, internal customers, and partners.

The QA Associate will demonstrate strong written and oral communication skills, thriving in a team environment while also working autonomously with self-management and organizational skills. The role requires influencing positive outcomes without direct reporting authority and valuing 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 escalation 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, quality guidelines, and site goals.
• Utilize paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records.
• Use technical skills and applied 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 or equivalent; degree preferred in Science (Chemistry, Biology, Biochemistry, Microbiology, etc.).
• 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.
• 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.).
• Visual acuity of 20/20 or better, with or without corrective lenses, as well as color vision.

Schedule

This position primarily supports second shift (3 pm to 11:30 pm) with occasional weekend support, dependent on operations’ needs.

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.

About the company

At INCOG BioPharma, we have built a world-class CDMO for parenteral injectable drugs. Our culture prioritizes long-term value for customers through a service-culture 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 our Fishers, IN offices. Our campus is smoke-free.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.