QA Associate, Weekend Day or Night Shift

About the Role

The QA Associate will work closely with the Quality Manager to ensure site compliance with regulations, ISO standards, and organizational SOPs. This role supports the development of a Quality Mindset and a culture of efficiency, attention to detail, and on-time delivery. The QA Associate will identify operational and quality gaps, foster productive relationships with colleagues and internal customers, and communicate complex issues clearly to diverse audiences. This position thrives in a team environment but also requires autonomy, strong self-management, and organizational skills. The role influences positive outcomes without direct reporting authority and values collaboration with 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 deviations, implementing corrective actions, or escalating issues to management.
• Provide cross-functional support in deviation investigations using root cause analysis tools, report writing, and risk mitigation strategies.
• Promote safety expectations, positive intervention, and adherence to SOPs, compliance requirements, and quality guidelines.
• Utilize paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software) to ensure data integrity for site policies and batch records.
• Apply technical skills and statistics to analyze deviations and identify sources of variability 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 in a GMP Manufacturing environment, either in Quality or as an Operator in Pharmaceutical Manufacturing.
• Moderate knowledge of regulations and quality systems, including 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 data analysis software (Word, Excel, Visio, JMP, Minitab).
• Visual acuity of 20/20 or better, with or without corrective lenses.

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 role supports weekend operations (Friday–Sunday) with two available shifts:

• Days: 7:00 AM – 7:30 PM
• Nights: 7:00 PM – 7:30 AM

Candidates must demonstrate availability and flexibility for occasional support outside of their standard shift hours.

About the Company

INCOG BioPharma Services is a world-class CDMO specializing in parenteral injectable drugs. The company prioritizes a service-culture mindset, technical excellence, and collaboration. Positions are based in Fishers, IN, and the campus is smoke-free. INCOG BioPharma is an Equal Opportunity Employer, and all employment decisions are based on business needs, job requirements, and individual qualifications.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide sponsorship for work authorization or visas for this role.