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Senior Quality Assurance Auditor

1 month ago

West Jefferson, United States AmplifyBio Full time
About the Role

We are seeking a highly skilled Senior Quality Assurance Auditor to join our team at AmplifyBio. As a key member of our quality assurance team, you will be responsible for conducting audits and inspections to ensure compliance with federal regulations, company standards, and client specifications.

Key Responsibilities
  • Conduct audits of protocols, raw data, documents, records, reports, and inspect work being performed to ensure compliance with regulatory requirements, company standards, and client specifications.
  • Perform inspections of AmplifyBio facilities and corresponding documentation to ensure compliance with requirements.
  • Report audit findings to project leadership and management.
  • Advise operations regarding issues observed during inspections to mitigate risk.
  • Review project planning documents for compliance with stated requirements.
  • Utilize knowledge of specific instrumentation and equipment, laboratory techniques, and current FDA industry guidance to advise on compliant operations.
  • Interpret and apply existing and new regulatory requirements and industry standards to operations methods and practices.
  • Develop and execute Quality Assurance Audit Plans per project.
  • Demonstrate initiative and accountability, with ownership of complex projects.
Requirements
  • Bachelor's Degree in a related field; 2-10 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 GLP environment or other regulated QA Operations.
Preferred Qualifications
  • 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.
  • Proven leadership with mentoring responsibilities.
  • Proven risk management skills, including mitigation strategies.
About AmplifyBio

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.

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 to financial planning and legal assistance, we make sure to take care of our own.

We are an equal opportunity employer and 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
  • 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.