Technical Operations Support Specialist

Quva Pharma • Bloomsbury, NJ

110d • $49,000 - $68,000

About The Position

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 hands on support in the generation and execution of Technical Operations deliverables to include, but not limited to, process development/proof of concept studies, execution of process validation studies, new product transfers and 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. This position requires knowledge of existing processes and a comprehensive acquaintance with generation and approval of cGMP documentation to include Master Batch Records and Validations. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

Requirements

• Minimum High School Diploma.
• 3+ years' 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.
• 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.

Nice To Haves

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

Responsibilities

• 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 execute 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.
• 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 processes 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.
• Support the development and update of Standard Operating Procedures required to implement new products or processes and/or process improvements.
• Provide Quality Partners, Commercial Operations, and Executive Management visibility of shop floor concerns related to scheduled technical operations lots or routine production performance concerns.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Management of Companies and Enterprises
• Education Level: High school or GED