Quality Assurance Associate

The US Operations Quality Partner plays a critical role in ensuring high-quality products and services throughout their lifecycle. This position serves as a strategic business partner across internal and external organizations, breaking down silos to support safe, compliant, and customer-focused diagnostic solutions. You apply smart, risk-based approaches to quality and regulatory processes, drive continuous improvement, and help build a culture where quality is seen as both a competitive advantage and a shared responsibility.

Responsibilities

• Perform quality and regulatory activities required to meet Quality and Regulatory (Q&R) goals and objectives with minimal collaboration and guidance.
• Identify opportunities for process improvement and implement solutions in collaboration with stakeholders to increase productivity, reduce costs, and mitigate compliance risks.
• Author, review, and approve quality-related documentation to support changes, including performing technical reviews and collaborating with leadership on complex technical topics when needed.
• Prepare documentation and evidence to support internal and external audits and inspections.
• Complete all required training in designated learning systems and maintain up-to-date knowledge of applicable quality and regulatory requirements.
• Train, coach, and mentor other quality professionals, managers, and business partners in a professional manner to ensure business needs are met and quality standards are upheld.
• Identify, escalate, and help resolve quality and regulatory issues as they arise, providing practical and compliant solutions.
• Communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance to executive leadership in a timely and transparent manner.
• Work independently day-to-day with minimal supervision to correctly complete scheduled and unscheduled activities, making decisions within your scope of responsibility without unnecessary delay.
• Develop solutions to quality and compliance challenges and present both issues and proposed resolutions to management.
• Initiate, facilitate, participate in, and implement process improvements to meet site and global business needs, linking responsibilities to both local and global Quality and Regulatory functions.
• Drive innovation within your area of influence by enabling and implementing smart, risk-based, compliant processes that support quick and efficient innovation.
• Participate in large, cross-functional, or global squads and, when appropriate, take a leading role in cross-chapter or cross-functional initiatives.
• Build and maintain strong partnerships with colleagues and business partners to ensure alignment on strategic projects and day-to-day activities and to support mutually successful working relationships.
• Champion and advocate for an engrained quality mindset at the site, promoting quality as a core value and shared responsibility.
• Foster and sustain a culture of continuous improvement in processes, systems, and behaviors.
• Act as a role model for agile leadership behaviors and the organization's culture, mindset, and behaviors as defined in the operating principles.
• Support the organization's transformation to more agile ways of working, including new decision-making and governance practices and enhanced collaboration.
• Ensure that your work contributes directly to long-term strategic ambitions such as expanding patient access to high-medical-value diagnostic solutions, building a leading insights business, and improving patient outcomes through integrated ecosystem approaches.
• Demonstrate and follow operating principles, core competencies, and leadership commitments, and remain accountable for meeting agreed commitments.
• Manage shifting priorities effectively, balancing commitments and daily work requirements with minimal direction from your manager.
• Seek candid feedback on performance, act on that feedback, and recognize the contributions of teammates and peers.
• Establish strong collaborative relationships across departments and leverage these connections to achieve key results.
• Identify personal career goals and actively manage your development in collaboration with your manager.

Requirements

• At least 1 year of experience in a quality-related, laboratory, or regulated operations environment.
• Bachelor's or Master's degree in Life Science, Data Science, or a related discipline, or equivalent experience.
• Completed training as a technician or laboratory technician, or an equivalent qualification appropriate for the tasks.
• Hands-on experience in quality assurance practices within a cGMP or GMP-regulated environment.
• Ability to perform accurate data entry and maintain complete and reliable quality records.
• Experience with documentation management, including authoring, reviewing, and maintaining controlled documents.
• Familiarity with standard operating procedures (SOPs) and the ability to adhere to and improve them.
• Experience handling deviations, investigating issues, and documenting corrective actions in compliance with quality standards.
• Knowledge of batch records and their role in product release and traceability.
• Ability to prepare and maintain GMP-compliant quality records and documentation.
• Strong analytical and problem-solving skills applied to quality and regulatory challenges.
• Ability to work independently with minimal supervision while making sound, timely decisions within scope.
• Strong communication skills for clearly conveying quality and regulatory issues and risks to stakeholders, including leadership.
• Capability to coach and train less experienced quality professionals and business partners.
• Broad understanding of related disciplines that interface with quality, such as laboratory operations, manufacturing, or data management.
• Experience participating in cross-functional or global project teams or squads.
• Demonstrated ability to drive process improvements and support continuous improvement initiatives.
• Comfort with agile ways of working, including iterative decision-making and collaborative governance practices.
• Ability to build and sustain strong partnerships across departments and with business partners.
• Experience preparing documentation for audits and responding to auditor requests.
• Proven ability to advocate for a quality-focused culture and engrained quality practices at a site or within a team.
• Interest in and commitment to personal career development and continuous learning in quality and regulatory fields.

Work Environment

This is an onsite role based in a professional diagnostic and laboratory operations environment. The position follows a first-shift schedule, Monday through Friday, typically from 8:00 a.m. to 5:00 p.m. You work closely with cross-functional teams such as laboratory staff, operations, and regulatory colleagues, using standard quality systems, documentation tools, and GMP/cGMP-compliant processes. The environment emphasizes safety, compliance, and accuracy, with a strong focus on collaboration, continuous improvement, and agile ways of working. Attire is consistent with a professional and laboratory/operations setting, aligning with site safety and dress guidelines.

Pay and Benefits

The pay range for this position is $36.00/hr. Individual compensation offered within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan (Pre-tax and Roth post-tax contributions available)
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Contract position based in Indianapolis, IN. Fully onsite. Anticipated closing date: November 11, 2026.