Document Control Specialist, QA

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join 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.

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 Documents Control Specialist to join our growing team!!!

The ideal candidate is an experienced Documents Specialist with a track record of success in GLP and/or GMP environments.

This is a unique opportunity to be part of an emerging startup bringing innovative technology to advanced therapies.

What You’ll Do Here:

• Oversees the controlled document process using the electronic Quality Management System (Veeva QualityDocs)
• Prepares Document Change Controls and monitors through completion.
• Distributes documents as needed within the organization.
• Creates and/or assist in the upload of new documents according to internal procedures and policies.
• Reviews and updates documents for maintenance and quality control
• Provides training support to internal staff on the document control process.
• Creates templates for use by functional groups.
• Creates and manages virtual document binders and organizes content.
• Maintains confidentiality regarding sensitive documents.
• Coordinates and partners with archives for maintenance of record retention.
• Reports on the progress of documents.
• Assists with the regulatory document/record retention program (archives), as necessary.
• Develops risk assessment skills and supports management initiatives.
• Participates in process/continuous improvement efforts.
• Supports change management efforts.

We Would Love to Hear from You If:

• Associate or bachelor’s degree or higher in biological sciences or relevant field.
• Highly goal-driven approach and the ability to focus on time-sensitive objectives.
• 0-2 years in industry with GLP/GMP quality assurance/control experience.

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 on the basis of 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.