Senior QA Compliance Specialist

4 weeks ago

New Albany, United States Amplify Bio Full time

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:

* 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.

We Would Love to Hear from You If:

* 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.

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.

* 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

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.

  • Senior QA Compliance Specialist

    4 weeks ago

    Albany, New York, United States Amplifybio, LLC Full time

    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...

  • Senior QA Compliance Specialist

    4 weeks ago

    Albany, New York, United States Amplifybio, LLC Full time

    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...

  • Senior QA Compliance Specialist

    2 weeks ago

    Albany, New York, United States Amplifybio, LLC Full time

    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...

  • Senior QA Compliance Specialist

    1 week ago

    Albany, New York, United States Amplifybio, LLC Full time

    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...

  • Senior QA Compliance Specialist

    3 weeks ago

    New Albany, United States Amplifybio, LLC Full time

    Job DescriptionJob DescriptionAre 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...

  • Senior QA Compliance Specialist

    3 weeks ago

    New Albany, United States Amplifybio, LLC Full time

    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...

  • Senior QA Compliance Specialist

    4 weeks ago

    New Albany, United States Amplifybio, LLC Full time

    Job DescriptionJob DescriptionAre 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...

  • Senior QA Compliance Specialist

    1 week ago

    New Albany, United States Amplifybio, LLC Full time

    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...

  • Senior QA Compliance Specialist

    4 weeks ago

    New Albany, United States Amplifybio, LLC Full time

    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...

  • Senior QA Compliance Specialist

    2 weeks ago

    New Albany, United States Amplifybio, LLC Full time

    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...

  • Senior QA Compliance Specialist

    5 days ago

    New Albany, United States Amplifybio, LLC Full time

    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...

  • QA Specialist

    2 weeks ago

    New Brunswick, United States Cynet Systems Inc. Full time

    Must Have List: BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company. Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company. Additional experience in an area allied with cGMP Quality, Quality Systems,...

  • Code Compliance Specialist

    3 weeks ago

    Albany, United States Colliers Engineering & Design Full time

    Overview: Bergmann, an affiliate of Colliers Engineering & Design is currently looking for a Code Compliance Specialist to join our Architecture team. Bergmann joined Colliers Engineering & Design in late 2021, bringing to the company a team of talented and creative architects and full range of services from preliminary planning and feasibility studies...

  • Code Compliance Specialist

    1 week ago

    Albany, United States Colliers Engineering & Design Full time

    Overview: Bergmann, an affiliate of Colliers Engineering & Design is currently looking for a Code Compliance Specialist to join our Architecture team. Bergmann joined Colliers Engineering & Design in late 2021, bringing to the company a team of talented and creative architects and full range of services from preliminary planning and feasibility studies...

  • Senior Healthcare QA Test Analyst

    3 weeks ago

    Albany, United States NTT DATA Full time

    Req ID: 282817 NTT DATA Services strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a Senior Healthcare QA Test Analyst to join our team in Albany, New York (US-NY), United States (US). Overview...

  • Senior Healthcare QA Test Analyst

    2 weeks ago

    Albany, United States NTT DATA Services Full time

    Req ID: 282817  NTT DATA Services strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a Senior Healthcare QA Test Analyst to join our team in Albany, New York (US-NY), United States...

  • Senior Healthcare QA Test Analyst

    1 week ago

    Albany, United States NTT DATA Services Full time

    Req ID: 282817  NTT DATA Services strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a Senior Healthcare QA Test Analyst to join our team in Albany, New York (US-NY), United States...

  • Senior QA Analyst

    5 hours ago

    New York, United States Staff4Me Full time

    Staff4Me is currently seeking a highly experienced and proactive Senior QA Analyst to join our team. As a Senior QA Analyst, you will be responsible for ensuring the quality of our software products through rigorous testing and careful analysis. You will work closely with the development team to identify, document, and track defects, as well as contribute to...

  • Health Benefits QA Specialist

    1 month ago

    New York, United States Healthee Full time

    It's 2024, and we believe that health benefits should be as simple as breathing. Welcome to Healthee - your digital compass to navigate the vast world of healthcare benefits. Imagine discovering your coverage, identifying the right provider, understanding your costs, and booking an appointment-all in the time it takes to send a tweet! That's what we do, and...

  • Health Benefits QA Specialist

    2 weeks ago

    New York, United States Healthee Full time

    It's 2024, and we believe that health benefits should be as simple as breathing. Welcome to Healthee - your digital compass to navigate the vast world of healthcare benefits. Imagine discovering your coverage, identifying the right provider, understanding your costs, and booking an appointment-all in the time it takes to send a tweet! That's what we do, and...