Process Validation Specialist

Our Process Validation 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 providing hands on support in the development and execution of products, programs and processes designed to support QuVa Pharma product introduction and continued robustness as necessary to meet cGMP and DEA regulatory and company compliance requirements. This role will be the primary liaison between Quality Compliance, Analytical Chemistry, Operations, and logistics with direct responsibilities for process introduction, transfer, and improvement. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

What the Process Validation Specialist Does Each Day:

• 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

• Serve as a 'Train the Trainer' when implementing new processes targeted to support commercial operations or semi-automated systems newly designed for process efficiency

• Engage with Pharmacy Services, Quality, Operations, Automation, and Engineering in all areas required to meet Marketed Product commitments related to portfolio expansion and process improvement

• Generate and oversee the completion of 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

• Investigate process trends and complex deviations directing the execution of risk-based solutions deemed necessary to address business operational and compliance challenges. 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

• Traveling to other QuVa Pharma facilities as necessary to support scheduled process validation activities

Our Most Successful Process Validation Specialists:

• Have strong problem-solving skills including training in the scientific method

• Demonstrate interpersonal communication skills

• Motivate cross functional teams to meet aggressive timelines

• Are proficient in technical writing and current computer usage (Word, Excel, PowerPoint)

• Are able to make decisions in a constantly changing environment

Minimum Requirements for this Role:

• BS or Associates Degree in Life Sciences or Engineering related discipline

• Minimum 3 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

• Minimum of 2 years' experience in design and execution of Process Validation

• 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:

• Relevant certifications including Gowning Qualification, Aseptic Operator Simulation Certification, PTCB Certification (CPhT), and ACPE Sterile Certification

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."