- Review and approve all GMP documentation including SOPs, batch records, deviations and investigations, QC testing, study reports, validation/qualification protocols and summary reports, etc.
- Provide document review and feedback for CAL/PM program and Environmental Monitoring for the site.
- Manage and trend lot/product disposition activities.
- Provide training and guidance on Quality topics to foster a quality culture and quality mindset (i.e. Good Documentation Practices).
- Provide compliant investigations, review and approve investigations as needed.
- Provide overall direction to Quality and non-Quality personnel performing analytical data reviews and general analytical support.
- Support finished product shipments to clinical site in conjunction with logistics/clinical and supply chain functions.
- Support Tech Transfer activities for new projects.
- Participate in quality audits in support of GMP operations and regulatory requirements.
- Partner with Program Management, Manufacturing, Quality Control, Supply Chain and attend meetings in support of relevant manufacturing programs and activities.
- Present data during department and cross-functional meetings as needed.
- Perform other activities as required based on company needs.
- A bachelor's degree or higher in a relevant scientific discipline – Bioinformatics, Biology, Biochemistry, Chemistry, or other relevant area.
- A minimum of years of experience in Quality and GxP biotechnology or pharmaceutical environment with supervisory responsibilities.
- Understanding through prior experience of GMP regulation and guidelines related to the conduct of early phase clinical programs such as, 21 CFR Part 210 and 211.
- Must have extensive cGMP quality system knowledge and experience.
- Experience using and or managing eQMS, such as Veeva.
- Strong interpersonal skills, ability to work in a team environment, attention to detail and excellent problem resolution skills.
- Strong teamwork, leadership, organization, and communication skills.
- Experience in cell & gene therapy is a plus.
- 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.
- We are just getting started More benefits on the way
- An Opportunity to Change the World
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Sr./Specialist, Quality Assurance Operations - New Albany, 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 Senior/Specialist, Quality Assurance Operations to join our growing team
The ideal candidate is an experienced within Quality Assurance Operations with a track record of success in GMP environments who understands biologics processes (i.e. cell & gene therapy, aseptic environments, reagent control, contamination control).
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.
Compensation details: Yearly Salary
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