Quality Assurance Specialist Ii - Onsite In Etna, Oh

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together. 

Optum is seeking a dynamic and motivated individual to fill the role of Quality Assurance Specialist for Optum Specialty Distribution (OSD). The Quality Assurance Specialist will be assisting the team of an exciting new specialty distribution business serving patients with specialty and rare disease pharmaceutical manufacturers and healthcare providers by distributing and servicing therapies, at the frontier of healthcare.  
   

The successful candidate will be responsible for activities related to Quality Assurance, including conducting comprehensive quality checks, while monitoring compliance with all relevant regulatory requirements. This role will support supplier audits, investigations related to quality issues that arise, quality-related trainings and educational sessions, and the development of risk mitigation strategies. This candidate must be committed to continuous improvement to ensure quality control procedures and operational processes are optimized.

As a new Optum business, we are building on our strengths but also challenging the status quo. We are creating a business that is designed to specifically serve the unique needs of patient populations using Specialty Pharmacies and supports the opportunity for expansion into additional therapies, which require enhanced services and new capabilities over traditional specialty distributors.

This is a local ONSITE position that will report to 8940 Global Way, Etna, OH 43062, Monday - Friday 8am-5pm

Primary Responsibilities: 

• Assist with development and implementation of quality programs, including development of processes, policies and SOPs intended to ensure compliance with applicable quality regulations and practices (e.g., cGxP, DSCSA and other applicable DEA and FDA regulations - 21 CFR 200-299 and 1300-end requirements) within the pharmaceutical wholesale distribution industry
• Conduct comprehensive quality checks on pharmaceutical products and materials, adhering to established protocols and industry standards
• Monitor and verify compliance with all relevant regulatory requirements, including DEA, FDA, GMP, and ISO standards
• Evaluate and maintain accurate records of quality control processes, test results, and inspection reports
• Investigate and identify the root causes of quality issues or discrepancies, proposing effective corrective and preventive actions
• Collaborate with cross-functional teams to continuously improve quality control procedures and operational processes
• Provide training to staff on quality-related topics and best practices to enhance their understanding of quality management principles
• Assess potential risks to product quality, supply chain, and distribution, and develop risk mitigation strategies
• Track and manage non-conforming products, initiating appropriate corrective actions and assisting with product recalls if necessary
• Prepare and present regular quality performance reports to management, highlighting key findings and recommendations
• Promote a culture of Quality throughout all facets of daily operations
• Maintains effective working relationships with regulatory and client / customer quality organizations
• Assists in root cause analysis investigation
• Champions continuous improvement efforts
  
• Other duties as assigned

You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in. 

Required Qualifications: 

• 5 years of analytical and problem-solving abilities to investigate quality issues and implement effective solutions
• 1 years of experience in Quality Assurance within the pharmaceutical industry, with knowledge of distribution processes and compliance standards
• Experience working within the pharmaceutical wholesale distribution industry and familiar with USP 1079 (GDP).
• Experience in conducting audits that meet corporate and regulatory requirements
• Experience with quality systems and QA operations in an FDA/ DEA-regulated environment
• Experience using Quality Management Systems and Data Analysis Tools (ex: Archer, Nexus, Atlas)
• Familiar with DEA & FDA regulations, cGMP guidelines, ISO standards, and other relevant regulatory requirements
• Proficient in using Microsoft Office Suite 

Preferred Requirements:

• CQA or Six Sigma certification
• Technical writing experience
• Experience effectively managing time, resources and tasks to achieve strategic objectives
• SAP experience
• Experience working in a people centric environment, developing collaborative relationships
• Experience taking initiative, being a self-starter & embracing change
• Proficient in maintaining and reviewing documentation related to Quality Assurance process, including batch records, audits, and SOP's
• Proven effective written and verbal communication for interacting with cross-functional teams, regulators, and stakeholders
• Proven effective presentation and training skills

At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.    

Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity/Affirmative Action employers and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law. 

UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment