QA Associate, 2nd Shift

Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with regulations, ISO Standards, organization SOPs, as well as supporting 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.

The Quality Assurance Associate will exhibit excellent interpersonal skills and be capable of developing productive, customer‑centric working relationships with colleagues, internal customers, and partners. They will demonstrate excellent written and oral communication skills, articulating complex issues clearly to a range of audiences. They will thrive in a team environment while also working autonomously with strong self‑management and organizational skills. They will value process owners and subject matter experts and will influence positive outcomes without direct reporting authority.

• Maintain a QA presence and provide process confirmation on the manufacturing floor.
• Review and approve documentation for QA approval, including on‑floor batch record review, logbooks, work orders, procedures, etc.
• Collaborate with Manufacturing/Operations team and lead or support investigations to resolve equipment and process related deviations.
• Support other QA personnel with batch record reviews, material release, etc.
• Prioritize and coordinate time to balance production timelines with product quality assurances.
• Exercise rapid decision‑making in the preliminary evaluation of deviation scope and impact, requirements for product segregation, and implementation of initial corrective actions or escalation to Manager.
• Provide support in cross‑functional deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.
• Exemplify proactive safety practices, enforce best practices aligned to SOPs, compliance requirements, quality guidelines, and site goals.
• Utilize various 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 deviations and track sources of variability and error in site processes.
• Manage multiple projects in a fast‑paced environment.

• Position supports primarily second shift (3 p.m. to 11:30 p.m.) with occasional weekend support, dependent on operations’ needs.
• Bachelor’s degree required or equivalent; preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology, etc.).
• Minimum of 2 years of experience in a GMP manufacturing environment as Quality or as an Operator in 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 its criticality.
• Excellent written and verbal communication skills.
• General computer skills, including hands‑on work with computerized operations equipment (SCADA) and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).

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

INCOG Bio Pharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.

Discrimination or harassment based on these characteristics will not be tolerated.

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