Regulatory & Clinical Affairs Specialist

Our Regulatory & Clinical Affairs Specialist plays a vital role within our organization. Once you complete our training your responsibilities will include the creation of and updates to Quva labels Quva Bill of Materials (BOMs) at a corporate level (for all sites) maintenance of records with respect to product formulation and label information and third-party submissions to external databases. At Quva you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality affordable medication and data insights while promoting a culture of innovation collaboration and continuous improvement. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety efficacy and quality providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

What the Regulatory & Clinical Affairs Specialist Does Each Day:

• Organize create and update labels including finished goods and intermediate bulks
• Organize create and update product formulations and Bill of Materials
• Complete product formulations and labels in Master Control and Infor
• Update the LPL-picklist
• Prepare data and maintain records to ensure alignment with related systems and information
• Routinely evaluate FDA NDCs listing from Orange Book against approved products
• Prepare FDA Risk Evaluation and Mitigation Strategies
• Monitor for updates to FDA labeling requirements 503B labeling standards and other relevant organization updates such as ISMP USP 7 and ASTM
• Manage submissions to 3rd party databases (First Data Bank Cerner Medi-Span Merative)
• Support investigations for Pharmacy Services-related deviations and CAPAs and initiate Pharmacy Services labels and formulations-related Change Requests
• Screen 503B facilities for FDA 483s on labeling issues
• Resolve discrepancies related to labels and or other tasks assigned. Delegate risk management issues with team
• Provide backup for the Pharmacy Services Labels and Formulations team for planned and unplanned tasks as needed

Our Most Successful Regulatory & Clinical Affairs Specialist:

• Has a sense of urgency accountability and resourcefulness (e.g. work in changing environment)
• Is a self-starter and independent learner
• Promotes active listening with team members; Contributes appropriately to conversations; Has strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
• Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform

Minimum Requirements for this Role:

• Bachelors degree in science
• 2 years in an FDA cGMP environment
• Desire Quality or Pharmacy experience
• Efficiency with MS Office suite Excel PowerPoint
• 18 years of age
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Any of the Following Will Give You an Edge:

• College Major in Pharmacy or Chemistry
• Pharmacy certification/license

Benefits of Working at Quva:

• Set full-time consistent work schedule
• Comprehensive health and wellness benefits including medical dental and vision
• 401k retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• National industry-leading high growth company with future career advancement opportunities

About Quva:

Quva provides industry-leading health-system pharmacy services and solutions including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of Pharmas multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStreampartners with health systems to aggregate normalize and analyze large amounts of complex data across their sites of care and through proprietary machine learning transforms data into actionable insights supporting revenue optimization script capture inventory management drug shortage control and more. Quvas overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.

Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quvas Equal Opportunity Policy prohibits harassment or discrimination due to age ancestry color disability gender gender expression gender identity genetic information marital status medical condition military or veteran status national origin race religious creed sex (including pregnancy childbirth breastfeeding and any related medical conditions) sexual orientation and any other characteristic or classification protected by applicable laws. All employment with Quva is at will.

Required Experience:

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