Location: West Jefferson, OH
Company: Amplifybio
created as a Battelle spin-off. Aligned with, and supported by leading life sciences-focused investors, we partner with our clients to provide preclinical CRO services from single study and through full IND enabling studies. We have a strong focus and commitment to helping accelerate the commercialization of advanced therapies such as cell and gene therapies and vaccines.
Moving forward we will combine continuous improvement and innovation to become the preferred preclinical CRO in the industry, by working in partnership with our clients, and leveraging state of the art technologies and platforms we will enable our customers to accelerate and improve the product development cycle, from
concept to commercial. When you join our team , you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians and specialists across a variety of disciplines.
Our chemists, biologists, veterinarians, data scientists, engineers, pathologists, and other experts collaborate to deliver new and exciting breakthroughs. The future for Amplify Bio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees. Amplify Bio is seeking to hire a SR. /GLP Quality Assurance
Auditor to join our growing team! The Sr. /GLP QA Auditor Conducts audits and performs inspections to assure compliance to federal regulations, Amplify Bio standards, client specifications, internal policies, and any other applicable guidelines.
What You'll Do Here: Audits protocols, raw data, documents, records, reports, and inspects work being performed to assure compliance to regulatory requirements, standards, specifications, internal policies, and any other applicable guidelines. Performs inspections of Amplify Bio facilities and corresponding documentation to assure compliance to requirements. Issues recommended actions and backsses corrective actions based on observation(s).
Reports audit findings to project leadership and management. Advises operations regarding issues observed during inspections to mitigate risk. May review project planning documents (technical protocols, project plans, test plans, etc. ) for compliance with stated requirements. Utilizes knowledge of specific instrumentation and equipment, laboratory techniques, and current FDA industry guidance to advise on compliant operations. Interprets and applies existing and new regulatory requirements and industry standards to operations methods and practices. Develops and executes Quality Assurance Audit Plans per project.
Proven leadership with mentoring responsibilities. Demonstrates initiative and accountability, with ownership of complex projects. Demonstrates ownership of assignments with accountability and instills trust in project team. Proven risk management skills including mitigation strategies. Established internally as a regulatory subject matter expert and amongst peers as a leader in the organization. Identifies compliance gaps and actively drives process/continuous improvement efforts to minimize risk to the organization. Drives change management through use of effective strategies and own skills in order to facilitate organizational change initiatives.
We Would Love to Hear from You If: Bachelor's Degree in a related field; 10 years of experience in a quality assurance program and proven communication skills; or an equivalent combination of education and/or experience in a related field. Experience in a Gx P environment. Desired But Not Required: Experience with System Validation and Method Qualification. Experience with electronic Quality Management Systems, Laboratory Information Management Systems and 21 CFR Part 11 compliance. Experience interacting with external audits and regulatory agencies.
At Amplify Bio , we're committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization. Research shows that oftentimes women and minority groups only apply to open roles if they meet 100% of the listed criteria. Amplify Bio encourages everyone - including women, people of color, individuals with disabilities and those in the LGBTQIA+ community - to apply for our available positions, even if they don't necessarily check every box on the job description.
Hire for attitude and train for aptitude creates unique opportunities to build strong teams of smart, motivated individuals who love what they do. Amplify Bio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), interactionual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.
Amplify Bio will not tolerate discrimination or harassment based on any of these characteristics. If you have a disability or special need that requires accommodation, please let us know during the recruiting process. We are committed to the safety and wellness of our employees and customers. Therefore, COVID vaccination is required. Why You Will Love Working Here: We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work.
From a wellness program (did we mention we have an onsite gym and ping pong table? ), to financial planning and legal assistance, we make sure to take care of our own. Health, Dental, and Vision insurance that starts on your first day at Amplify Bio Competitive Compensation Package We take work-life balance seriously and we back it up with a FLEXIBLE PTO policy! Life and AD&D insurance Supplemental insurance Live Health Online Smart Shopper (helps you shop for better medical care and earn cash rewards while you save) 4 weeks paid Parental Leave Wellness Program 401(k) match Tuition Reimbursement EAP/work-life support system A fun work environment where everyone's voice matters!
We are just getting started! More benefits on the way! An Opportunity to Change the World! PI61d PDN-9ad9dcfd-13c6-44a6-83ea-b285da3690b2
OH (Close proximity to Cleveland/Akron) Work Arrangements: Hybrid ~25% in office presence In this role you will: Works on and leads various project deliverables including but not limited to: Test plans, detailed test schedules, test environment plans Owns and facilitates the design, construction and execution of test cases/ test scenarios Collaborates with Business Analysts to ensure requirements are testable and well defined Analyzes system architecture and designs testing strategy as appropriate Creates functional design in collaboration with IT development teams Defines and publishes project testing metrics Leads testing efforts on PMO led projects: Defines test schedule through collaboration
with Project Manager Helps to inform revisions to overall plan with Project Manager Continues to revise plan and adapt to project changes with Project Manager Manages cross-functional testing efforts with complex dependencies Role models the use of standards and methodologies around testing management Effectively manages the test schedule in alignment with triple constraint: Budget, Time, Scope Develops and promotes testing best practices: Leverages and enhances standard testing deliverables Incorporates automated testing where appropriate to increase test coverage Leverages and develops key testing metrics and dashboards Proactively executes best practices regarding audit and security controls
Identifies potential risks to delivery, both inside and outside of own workstream, identifying and presenting possible solutions Advancement of QA Profession: Guides and mentors others to help advance quality assurance as a discipline, practice and profession Seeks opportunities to lead change and share knowledge The Right Place for You We are bold, kind, strive to do the right thing, we play to win, and we believe in a strong community that thrives together.
Our culture is rooted in our Basic Beliefs , and we believe in supporting every employee by meeting their physical, emotional, and financial needs. What we are looking for: Minimum Requirements:5+ years of relevant work experience Proficiency with Microsoft Project and HP Application Lifecycle Management (ALM)Proven ability to influence and shape outcomes through strong interpersonal and communication skills Demonstrated ability to think critically and conceptually Customer service mindset with a commitment to quality deliverables Additional skills and experience that we think would make someone successful in this role (not required): Experience leading project management activities with a strong understanding of project management methodology Learn more about working at Smucker: Our Total Rewards Benefits Program Our Thriving Together Philosophy Supporting All Impacted by Our Business Our Continued Progress on Inclusion, Diversity and Equity Follow us on Linked In #LI-CM1#LI-Hybrid
