- Implement and manage systems for Quality Management, Quality Assurance, Data stewardship, and governance.
- Maintain complaint and nonconformance processing through records and tracking systems, including FMEA, root-cause analysis and corrective actions.
- Participate in drafting quality assurance agreements as required.
- Analyze operational and delivery processes, and ensure that they comply with company standards, industry regulations, state/federal laws, and sets the standard for best practices.
- Ensure product and facility compliance with AmplifyBio policies and procedures, US and Global Quality System Regulations including, but not limited to 21CFR11, 21CFR210, 21CFR211, and EudraLex Volume 4 Annex 1
- Identify and investigate gaps in process, policy, procedures and First Line of Defense controls.
- Support completion of analysis, identify issues and provide recommendations for compliance process improvements both internally and with clients.
- Develop and report on KPIs / metrics for the Quality Management System to identify areas for improvement.
- Provides site training on for investigation tools.
- Manage deviation, CAPA and Change Control review boards.
- A bachelor's degree or higher in a relevant scientific discipline or equivalent education and experience
- A minimum 5+ years of experience within the Quality Unit in a GMP pharmaceutical environment.
- Must have experience with deviation and CAPA management, ASQ Certified Pharmeceutical GMP Professional a strong plus.
- Experience enforcing GMP regulation and guidelines related to the conduct of early phase clinical programs through commercial manufacturing.
- Ability to work with minimal supervision.
- Strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
- Ability to apply a risk-based approach related to this role.
- 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 UNLIMITED 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.
- We are just getting started More benefits on the way
- An Opportunity to Change the World
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Senior QA Compliance Specialist - New Albany, OH, US, United States - Amplifybio, LLC
Description
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 AMEC New Albany, OH: AmplifyBio's Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a "hoteling model," traditional contract development and manufacturing (CDMO) or a hybrid model. Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. The goal is to provide flexible solutions customized to client needs while bringing full expert partnership. At AmplifyBio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.
AmplifyBio is seeking to hire a Sr. QA Compliance Specialist to join our growing team
The Sr. QA Compliance Specialist is responsible for the execution of the Quality Management System for the New Albany GMP facility. This role will ensure Quality Events are performed in a timely manner to meet quality and business objectives. The ideal candidate is a hands-on leader with experience in GMP drug manufacturing.
What You'll Do Here:
We Would Love to Hear from You If:
At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. Therefore, 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 to financial planning and legal assistance, we make sure to take care of our own.
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.
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