Senior Quality Associate

2 days ago


Indianapolis, Indiana, United States Skills Alliance Full time

Position:
Senior Quality Associate

Location:
Indiana, USA

The Company:

A growing CDMO organization focused on the GMP production of biologics and advanced therapies. The site supports clinical and commercial manufacturing for global partners, ensuring high-quality products and strict adherence to regulatory requirements.

Position Overview:

The Senior Quality Associate will provide hands-on QA support for manufacturing operations, ensuring compliance with GMP standards and quality systems. This role is independent and operationally focused, supporting deviations, change controls, CAPAs, and media fill/qualification activities while maintaining rigorous oversight of the production environment.

Key Responsibilities:

  • Support GMP manufacturing operations from a QA perspective, ensuring compliance with internal and external standards.
  • Review and manage deviations, CAPAs, change controls, and other quality documentation.
  • Participate in media fill, qualification, and process verification activities.
  • Collaborate with manufacturing teams to ensure adherence to quality requirements and GMP practices.
  • Contribute to audits, inspections, and internal quality reviews.
  • Ensure accurate and timely documentation of QA activities in accordance with GMP.

Candidate Profile:

  • Bachelor's degree or higher in a scientific or technical discipline.
  • 6+ years of experience in a CDMO or Bio/Pharma environment.
  • Strong hands-on QA experience supporting GMP manufacturing operations.
  • Knowledge of deviations, CAPAs, change control, and media fill/qualification processes.
  • Strong attention to detail, organizational skills, and ability to work independently.
  • Onsite, full-time availability.

I look forward to receiving your application



  • Indianapolis, Indiana, United States CTI And Associates Inc. Full time

    Senior Construction Quality Assurance (CQA) ManagerCTI and Associates, Inc. – Indianapolis, INCTI and Associates, Inc. (CTI) provides geotechnical, environmental, and construction management services to federal, state, municipal, and commercial clients nationwide. For over forty years, CTI has earned a reputation for technical excellence, safety, and...


  • Indianapolis, Indiana, United States Eli Lilly and Company Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Indianapolis, Indiana, United States Versiti, Inc. Full time

    OverviewVersiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together...


  • Indianapolis, Indiana, United States Roche Full time

    At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...


  • Indianapolis, Indiana, United States Mortenson Full time

    SummaryMortenson is currently seeking an experiencedSenior Quality Managerto lead, manage, document, monitor, and analyze the quality system on one or more significant projects; and lead necessary corrective and preventive actions.ResponsibilitiesIncorporate and lead Mortenson's quality system on one or more significant projects:Lead planning, development,...


  • Indianapolis, Indiana, United States Azuria Water Solutions Full time

    Insituform Technologies, LLC is seeking an experienced Senior Quality Manager.Insituform Technologies, LLC, a subsidiary of Azuria Corporation, is a leading worldwide provider of highly specialized cured-in-place pipe (CIPP) and other technologies and services for the rehabilitation of pipeline systems. Insituform's businesses consist of sewer, drinking...


  • Indianapolis, Indiana, United States TempStaffing,Inc Full time

    Temp To Full-TimeAs a Quality Control Associate, you will play a crucial role in ensuring the high standards of our products/services through meticulous inspection and testing processes. You will collaborate with cross-functional teams to uphold quality assurance standards, identify areas for improvement, and contribute to the continuous enhancement of our


  • Indianapolis, Indiana, United States CVS Health Full time

    At CVS Health, we're building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care.As the nation's leading health solutions company, we reach millions of Americans through our local presence, digital channels and more than 300,000 purpose-driven colleagues – caring for...


  • Indianapolis, Indiana, United States DuCharme McMillen & Associates Full time

    As an employee-owned company, DMA prioritizes employees. Low turnover rates and tenured teams are living proof:  2025 Great Places to Work CertifiedEmployee stock ownership program eligibility begins on day one of employment (ESOP contribution is targeted at 6% of your annual compensation)Company paid parental leaveGenerous time off package Multiple...


  • Indianapolis, Indiana, United States KSM (Katz, Sapper & Miller) Full time $80,000 - $120,000 per year

    Job DescriptionWe're KSM, one of the top 50 largest independent advisory, tax, and audit firms in the United States. But more than our size, it's our people and culture that set us apart. We believe great things happen when people are supported, challenged, and given the freedom to do their very best work. That's why we've built a workplace where your career...