Senior Technical Operations Support Specialist

Our Senior Technical Operations Support Specialist plays a vital role within our organization. Once you complete our training your responsibilities will include driving continuous process improvement in sterile-to-sterile compounding operations. 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 Title Does Each Day:

• Report directly to the Director Technical Operations with minimal supervision supporting daily production operations at the Sugar Land facility to minimize impact of routine schedule changes on weekly customer commitments
• Serve as the subject matter expert in the flow of production materials components and equipment to streamline production operations on a weekly basis
• Evaluate product codes and various process types to identify opportunities for campaign manufacturing that would help absorb impact of routine changes in production dynamics
• Provide compounder training support to Operations department
• Engage with Pharmacy Services Quality and Operations to develop batch record templates and BOMs for routine production
• Generate change control documentation as necessary to support introduction of new products or process improvements
• Support the development and update of Standard Operating Procedures required to implement new products or process and/or process improvements
• Develop knowledge transfer plans and training strategies for new processes or process improvements from Technical Operations to routine production personnel and oversee the lifecycle of these changes
• Develop and implement production support programs that help ensure compliance to industry standards while at the same time streamline process efficiencies such as balance and weight calibrations
• Represent the operations function in investigation and documentation of process related Notice of Events (NOEs) and Variances as required
• Provide experienced input for continued process improvement initiatives
• Provide Quality Partners Commercial Operations and Executive Management visibility of shop floor concerns related to routine production performance concerns
• Other duties as assigned

Our Most Successful Title:

• Strong problem-solving skills including use of the scientific method
• Strong analytical skills
• Ability to make decisions in a constantly changing environment
• Demonstrated interpersonal communication skills
• Proficient in technical writing
• Microsoft office including Word Excel PowerPoint
• Ability to motivate cross functional teams to meet aggressive timelines

Minimum Requirements for this Role:

• Legally authorized to work in the job posting country
• Minimum of a Bachelors Degree
• Relevant certifications including Gowning Qualification Aseptic Operator Simulation Certification PTCB Certification (CPhT) and ACPE Sterile Certification
• Minimum 5 years experience in sterile-to-sterile compounding operations and distribution of sterile pharmaceutical products
• Experience in the supervision of daily compounding operations and an in-depth knowledge of the intricacies specific to various product codes and process types
• Incumbent must possess extensive knowledge of cGMPs and aseptic techniques
• Good working knowledge of regulatory guidance as it pertains to sterile-to-sterile compounding operations
• Experience in Aseptic Operator Qualification and Process Simulation
• Personnel and material flow patterns required for sterile environments
• Ability to sit and/or stand 8 hours or more per day if needed
• Ability to manipulate necessary office equipment computer software hardware & equipment
• Ability to perform the following physical activities: stooping reaching standing grasping walking feeling talking and hearing

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.

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Required Experience:

Senior IC