US_Operations Quality Partner I_CO

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The Fountain Group is currently seeking a Quality Operations Specialist for a prominent client of ours. This position is located at Indianapolis, IN. Details for the position are as follows:
 
Title: Quality Operations Specialist
Location: Indianapolis, IN
Duration: 12 months (With Possible Extension/Hire)
Pay : $34.00 - $36.00/ hours

Key Responsibilities:

• Support Quality and Regulatory (Q&R) goals and objectives with minimal supervision.

• Independently manage daily quality activities and identify opportunities for process improvements.

• Author, review, and maintain quality documentation, including technical documents and change-related records.

• Perform technical reviews and support quality documentation requirements.

• Prepare and maintain documentation for internal and external audits.

• Identify, communicate, and escalate significant quality or regulatory issues that may impact product quality or compliance.

• Coach, train, and mentor quality professionals and business partners.

• Initiate and implement process improvements to enhance productivity, reduce costs, and mitigate compliance risks.

• Collaborate with internal and external stakeholders across departments and global quality organizations.

• Support cross-functional and global projects, contributing to quality initiatives and business objectives.

• Promote a culture of quality, compliance, collaboration, and continuous improvement.

• Support the implementation of risk-based quality processes and innovative ways of working.

• Complete all required organizational and compliance training.

Required Qualifications:

• At least 1 year of relevant experience.

• Bachelor's or Master's degree in Life Sciences, Data Science, or a related discipline, or equivalent experience.

• Completed training or qualification as a technician or laboratory technician, or equivalent qualification relevant to the assigned responsibilities.

• Understanding of quality and regulatory requirements.

• Ability to manage daily activities independently with limited supervision.

• Strong documentation, communication, problem-solving, and organizational skills.

• Ability to collaborate effectively with cross-functional teams and stakeholders.

Preferred Experience:

• Quality Assurance or Quality Control experience.

• Experience with quality documentation, technical reviews, and audit preparation.

• Familiarity with regulatory compliance and risk-based quality processes.

• Experience supporting process improvements and continuous improvement initiatives.

• Experience coaching, training, or mentoring team members.

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