QA Associate

About the role

The QA Associate will play a crucial role in ensuring site compliance with Regulations, ISO Standards, and organization SOPs. They will champion and develop a quality mindset and culture of efficiency, attention to detail, and on-time delivery.

Responsibilities

• Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor.
• Review and approve documentation for Quality approval, including batch record review, logbooks, work orders, procedures, etc.
• Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations.
• Support other QA personnel with batch record reviews, material release, etc.
• Prioritize and coordinate time in balancing production timelines with product quality assurance.
• Exercise rapid decision-making in evaluating the scope and impact of deviating events, requirements for product segregation, and implementing initial corrective actions or escalating issues to Manager for resolution.
• Provide support in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools.
• Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align 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 and track deviations and identify sources of variability and errors 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 with experience working as 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 its criticality.
• 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.).

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.

Special Job Requirements

• This position will support primarily first shift (6 am to 2:30pm) with occasional weekend support, dependent on operations’ needs.

Additional Preferences

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

Benefits

INCOG BioPharma Services offers a competitive benefits package including health insurance, retirement plans, paid time off, and more. We are committed to fostering a supportive and inclusive workplace culture.

Schedule

This position supports primarily first shift (6 am to 2:30pm) with occasional weekend support, dependent on operations' needs.

Pay

Competitive compensation package is offered based on experience and qualifications.

Company Info

At INCOG BioPharma, we are a CDMO for parenteral injectable drugs. Our culture and priorities are designed to build long-term value for our customers, focusing on a service-culture mindset, technical excellence, and a collaborative approach to business. We are an Equal Opportunity Employer and prohibit discrimination and harassment of any kind. Qualified applicants must be authorized to work in the United States on a full-time basis.