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Quality Assurance Engineer

Actalent

Cicero · On-site Full-time Mid Level $72k – $77k/yr Today

About the role

Job Title

Quality Assurance Engineer

Job Description

The Quality Assurance Engineer is responsible for supporting the Quality organization in conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance.

Responsibilities

  • Identify and implement corrective actions and investigate exceptions (deviations).
  • Generate or review change controls for batch records, standard operating procedures, standard test methods, specifications, and data sheets.
  • Employ quality tools such as FMEA, Fishbone, 5 Why, and risk analysis to support investigations and special projects.
  • Perform data analysis to support investigations, cost savings, and continuous improvement initiatives.
  • Work with radioactive materials.
  • Ensure a safe and quality working environment through training, awareness, and compliance with safety and quality guidelines and SOPs.
  • Maintain current knowledge of US and international quality regulations.
  • Author or perform peer reviews of annual product quality reviews.
  • Provide support for regulatory agency on‑site audits as required.
  • Maintain operational compliance with US and international regulatory agencies and guidelines such as FDA, EU, HC, TGA, PIC/S, USP, NRC, and cGMP.

Essential Skills

  • Bachelor of Science degree or equivalent work experience in lieu of a degree.
  • 3‑7 of relevant experience in the pharmaceutical industry.
  • Strong investigations experience.

Additional Skills & Qualifications

  • Ability to resolve problems, handle conflict, and make effective decisions under pressure.
  • Ability to perform simple to complex math calculations and analyze data.
  • Hands‑on, analytical, and problem‑solving skills.
  • High level of energy and consistent attendance.

Work Environment

This is an onsite position.

Job Type & Location

This is a Permanent position based out of Noblesville, IN.

Pay and Benefits

The pay range for this position is $72,000.00 – $77,000.00/yr.

  • Medical Insurance
  • Dental & Vision coverage
  • 401(k) retirement Plan
  • Paid time off and holidays

Workplace Type

This is a fully onsite position in Noblesville, IN.

Application Deadline

This position is anticipated to close on Mar 31, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self‑reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Requirements

  • Bachelor of Science degree or equivalent work experience in lieu of a degree
  • 3-7 of relevant experience in the pharmaceutical industry
  • Strong investigations experience
  • Additional Skills & Qualifications
  • Ability to resolve problems, handle conflict, and make effective decisions under pressure
  • Ability to perform simple to complex math calculations and analyze data
  • Hands-on, analytical, and problem-solving skills
  • High level of energy and consistent attendance

Responsibilities

  • The Quality Assurance Engineer is responsible for supporting the Quality organization in conducting investigations, change management, identifying and implementing continuous improvement opportunities, and maintaining GMP compliance
  • Identify and implement corrective actions and investigate exceptions (deviations)
  • Generate or review change controls for batch records, standard operating procedures, standard test methods, specifications, and data sheets
  • Employ quality tools such as FMEA, Fishbone, 5 Why, and risk analysis to support investigations and special projects
  • Perform data analysis to support investigations, cost savings, and continuous improvement initiatives
  • Work with radioactive materials
  • Ensure a safe and quality working environment through training, awareness, and compliance with safety and quality guidelines and SOPs
  • Maintain current knowledge of US and international quality regulations
  • Author or perform peer reviews of annual product quality reviews
  • Provide support for regulatory agency on-site audits as required
  • Maintain operational compliance with US and international regulatory agencies and guidelines such as FDA, EU, HC, TGA, PIC/S, USP, NRC, and cGMP
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes

Benefits

Pay and BenefitsThe pay range for this position is $72000.00 - $77000.00/yrmedical Insurance - Dental & Vision coverage - 401 (k) retirment Plan - Paid time off and holidaysEnsuring growth opportunities for our people

Skills

FMEAFishbone5 Why

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