Technical Operations Support Specialist

Our Technical Operations Support Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include product transfer gap assessments (based on sending site information), process development/proof of concept studies, Bloomsbury Product Introduction Forms, process validation studies, API Conversions, process investigations, and process improvement initiatives.  

This individual will also provide support in the detection and resolution of difficult to detect process errors and frequently interact with individuals from other functions within the company.  Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US. 

What the Technical Operations Support Specialist Does Each Day: 

• Report directly to the Manager, Technical Operations with minimal supervision in the execution of assigned deliverables required to fulfill Tech Ops commitments
• Generate technical information, often in the form of process data, required to fulfill assigned deliverables without the support of established procedures
• Generate and execution of development, validation, and engineering documentation necessary to formally capture product introductions, process investigations, and process improvements
• Generate Knowledge Transfer and Training Plans to support the transition of knowledge from the Tech Ops community into routine production environment
• Provide compounder and formulator training with respect to new products or processes as necessary to fulfill planned knowledge transfer requirements
• Engage with Pharmacy Services, Quality, Operations, and R&D to support development and approval of Master Batch Records and associated labels for new products being introduced at the site
• Complete training curricula and any Competency Assessment requirements to perform routine product formulation process steps to ensure new products and/or processes are designed in accordance with current standard operating procedures
• Routinely communicate with Tech Ops individuals at other QuVa Pharma sites to leverage process knowledge to ensure similar process are aligned and consistent with best practices and company standards
• Generate change control documentation as necessary to support introduction of new products or process improvements
• Provide experienced input for continued process improvement initiatives designed to support efficiency
• Provide experienced input with Root Cause Investigations related to process variances or customer complaints and lead the execution of Root Cause Analysis cross functional teams as assigned. Once completed, summarize the root cause investigational activity in the form of cGMP investigation report

Our Most Successful Technical Operations Support Specialists: 

• Have strong problem-solving skills, including use of the scientific method
• Have strong analytical skills
• Make decisions in a constantly changing environment
• Demonstrate interpersonal communication skills
• Are proficient in technical writing
• Motivate cross functional teams to meet aggressive timelines

Minimum Requirements for this Role: 

• 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 
• Minimum High School Diploma
• Minimum three (3) years of relevant experience in the manufacture and distribution of sterile Pharmaceutical/Biological products
• Experience in site-based manufacturing, quality operations, and/or research and development roles
• Execution of product transfer and validation of formulation, manufacture, and distribution of sterile Pharmaceutical/Biological products
• Extensive knowledge of cGMPs
• Good working knowledge of regulatory guidance as it pertains to APIs and injectable drug products
• Experience in Aseptic Operator Qualification and Process Simulation programs
• Experience with personnel and material flow patterns required for sterile environments
• Proficient in Microsoft office including Word, Excel, PowerPoint

Any of the Following Will Give You an Edge: 

• Experience with product and/or process validation concepts
• Experience at multiple sites and across multiple functions

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
• National, industry-leading high growth company with future career advancement opportunities

About QuVa: 

QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide. As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality. 

As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery. 

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. QuVa's 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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