Gardner Resources Consulting, LLC

Support and drive quality outcomes and operational excellence in GLP studies through collaboration, audit participation, document review, and training. | Bachelor's degree in a scientific field, strong GLP experience, pharmaceutical or CRO background, with preferred RQAP-GLP certification. | GLP Operational Quality Manager Key Responsibilities: · Support the GLP Operational Quality team and business partners in driving quality outcomes and operational excellence. · Maximize the value, impact, and delivery of quality oversight activities to ensure compliance and excellence in quality. · Collaborate with the Quality Analytics team to develop meaningful quality indicators for ongoing evaluation of process and quality system health, as well as risk identification. · Work closely with other R&D Quality members to support scalable quality approaches and ensure consistency in execution across products and programs. · Participate in regulatory document reviews, identifying potential risks or gaps in Investigator Brochures, INDs, BLAs, and NDA's. · Provide input in the development of audit scope and focus for vendor audits. · Contribute to pro-active inspection readiness activities by conducting quality assessments of GLP studies either on-site or remotely. · Collaborate with preclinical stakeholders and quality partners to develop appropriate metrics related to GLP activities. · Participate in creating and presenting content for annual GLP refresher training. Perform other duties as assigned. Requirements: · Bachelor's degree or equivalent in a related scientific field. · Strong experience in GLP (Good Laboratory Practices) and reviewing data and documents supporting GLP studies and submissions. · Experience in Pharmaceuticals or Contract Research Organization (CRO) · RQAP-GLP certification is preferred, but not mandatory. · Ability to work independently and meet timelines in a fast-paced environment. Excellent communication and collaboration skills. Travel Requirements: This role may require up to 20% travel.

Provide expertise in Epic Beaker CP for clinical pathology laboratory informatics, focusing on microbiology workflows during a 3-month contract. | Must have Epic Beaker CP certification, bachelor's degree, 5+ years relevant experience, and microbiology expertise. | We are seeking an Epic Beaker CP / Laboratory Informaticist for a 3-month contract with likely extension (Remote) • Epic Beaker CP (Clinical Pathology) certification required (online certification verification required) • Bachelor's degree required • Needs to be experienced with Microbiology • 5+ years of relevant experience required

Manage multiple complex UX projects in a cross-functional product environment using agile methodologies and UX tools. | 7+ years in UX program/project management with expertise in UX tools and methodologies, strong communication, and stakeholder management skills. | Sr UX Producer Qualifications • 7+ years of experience in UX program or project management, preferably in a cross-functional product environment. • Expertise in tools such as JIRA, JPD, Smartsheet, Confluence • Deep understanding of UX disciplines including design, research, human factors, content strategy, and instructional design. • Proven ability to manage multiple complex projects with competing priorities. • Strong communication, facilitation, and stakeholder management skills. • Experience with agile methodologies, design thinking, and UX tooling (e.g., Figma, Miro, Jira, Confluence). • Experience in Med device is a plus. • Background in UX design or User Research is a plus.