Quality Assurance Associate

About the Role

As a Quality Assurance (QA) Associate at INCOG BioPharma Services located in Fishers, IN, you will work directly with the QA Supervisor to ensure that our site remains compliant with regulatory and ISO standards, as well as company SOPs. Your efforts will help foster a quality-focused mindset and a culture centered around efficiency, precision, and timeliness. You'll be integral in identifying gaps in operations and quality systems.

Key Responsibilities

• Maintain active QA oversight on the manufacturing floor to confirm process adherence.
• Review and approve various quality documentation including batch records, logbooks, work orders, and procedures.
• Partner with Manufacturing and Operations teams to lead or assist in investigations addressing equipment or process deviations.
• Assist other QA staff with batch record evaluations and material release processes.
• Effectively balance production schedules with quality assurance priorities.
• Make swift preliminary assessments regarding deviations, product segregation needs, and corrective measures or escalate as necessary.
• Support cross-functional teams in deviation root cause analyses, reporting, and risk mitigation strategies.
• Promote safety by enforcing SOP compliance and best practices, including proactive safety interventions.
• Utilize both paper-based and automated systems (e.g., Veeva, SCADA, BMS, CMMS, LIMS) to uphold data integrity aligned with site policies and standards.
• Apply technical and statistical analyses to monitor deviations and pinpoint variability sources within processes.
• Manage multiple projects efficiently in a dynamic and fast-paced environment.

Position Details

• This role primarily covers first-shift hours (7:00 AM to 4:00 PM) with occasional weekend support based on operational needs.
• Bachelor’s degree or equivalent is required, preferably in a scientific discipline such as Chemistry, Biology, Biochemistry, or Microbiology.
• Visual acuity of 20/20 (with or without correction) is mandatory.
• A minimum of two years’ experience in Quality within a GMP manufacturing setting or operational Pharmaceutical Manufacturing experience is necessary.
• Familiarity with regulations and quality systems including deviation management, Non-Conformance, and CAPA processes is expected.
• Comprehensive understanding of Good Documentation Practices (GDP) and their critical role in compliance.
• Strong verbal and written communication skills to clearly articulate complex topics.
• General computer proficiency including use of computerized operations equipment (such as SCADA) and software tools like Word, Excel, Visio, JMP, and Minitab.

Preferred Qualifications

• Practical experience in aseptic manufacturing, inspection of finished goods, and understanding of Acceptable Quality Limits (AQL).
• Background or training in continuous improvement methodologies such as Six Sigma and Lean principles.

About INCOG BioPharma Services

INCOG BioPharma is a specialized Contract Development and Manufacturing Organization (CDMO) focused on parenteral injectable drugs. We prioritize long-term customer value through technical excellence, teamwork, and customer-driven service culture. Our work environment supports creating novel systems and continuous improvement to benefit clients by ensuring exceptional quality and faster market readiness. All roles are based at our Fishers, Indiana location, which is a smoke-free campus.

Equal Opportunity and Legal Notice

INCOG BioPharma is an Equal Opportunity Employer committed to a discrimination- and harassment-free workplace. Employment decisions are strictly based on business requirements and qualifications without regard to race, color, religion, gender, age, disability, sexual orientation, familial status, or any other legally protected characteristic. Applicants must be authorized to work in the U.S. full-time without visa sponsorship or authorization support from the company.

Candidate Declaration

Applicants affirm that the information provided in their application is truthful and accurate.