AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.
The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)– Amplify’s Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) – Amplify’s Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) – Amplify’s Manufacturing Enablement Center.
About ASET West Jefferson, OH: AmplifyBio’s safety, efficacy, and toxicology unit (ASET) was launched as a preclinical CRO that spun out of Battelle in 2021 to address the changing needs of commercial organizations developing modern therapeutics. AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes. Among the investments that AmplifyBio has made to empower preclinical assessments of advanced therapies is building a new state-of-the-art analytical laboratory to include molecular and immunological assays that assess critical safety and efficacy indicators for cell and gene therapies during preclinical studies
AmplifyBio 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, AmplifyBio 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 AmplifyBio facilities and corresponding documentation to assure compliance to requirements. Issues recommended actions and assesses 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 GxP 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 AmplifyBio, 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.
AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don’t discriminate based on race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual 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.
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 with state-of-the-art equipment 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 AmplifyBio!
- Competitive Compensation Package
- We take work-life balance seriously and we back it up with a FLEXIBLE PTO policy!
- Generous paid parental leave
- Wellness and Self-Care Programs
- 401(k) match
- Tuition Reimbursement
- EAP/work-life support system
- A fun work environment where everyone’s voice matters!
- An Opportunity to Change the World!!!
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. The future for AmplifyBio 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.