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Senior Quality Assurance Operations Specialist
2 months ago
Are you driven by the desire to enhance the future of healthcare? Do you recognize that a company's greatest asset is its people? If so, consider joining Amplify Bio .
Amplify Bio stands as a premier contract research organization, offering a wide array of services that encompass being an outsourcing partner for discovery phase R&D, a preclinical CRO executing safety, efficacy, and toxicology assessments for both small molecules and advanced therapies, and an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics.
The Amplify Bio ecosystem consists of three specialized 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 newly established AMEC (New Albany, OH) – Amplify's Manufacturing Enablement Center.
About AMEC New Albany, OH : Amplify Bio's Manufacturing Enablement Center offers customizable cGMP suites to facilitate advanced therapy manufacturing in a flexible model, traditional contract development and manufacturing (CDMO), or a hybrid approach. Collaborating with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modalities is distinct from a conventional CDMO experience. Our aim is to deliver tailored solutions that meet client needs while providing comprehensive expert partnership. At AmplifyBio, drug developers will discover an innovation-rich ecosystem designed to propel a diverse range and class of pharmaceutical products through various development stages.
Amplify Bio is looking to recruit a Senior Quality Assurance Operations Specialist to become part of our expanding team.
The ideal candidate will possess substantial experience in Quality Assurance Operations with a proven record of success in GMP environments, particularly in biologics processes (e.g., cell & gene therapy, aseptic environments, reagent control, contamination control).
Key Responsibilities:
- Review and authorize all GMP documentation, including SOPs, batch records, deviations and investigations, QC testing, study reports, validation/qualification protocols, and summary reports.
- Provide document review and feedback for the CAL/PM program and Environmental Monitoring for the site.
- Oversee and analyze lot/product disposition activities.
- Deliver training and guidance on Quality topics to cultivate a quality culture and mindset (e.g., Good Documentation Practices).
- Conduct compliant investigations and review and approve investigations as necessary.
- Offer overall direction to Quality and non-Quality personnel involved in analytical data reviews and general analytical support.
- Assist with finished product shipments to clinical sites in collaboration with logistics/clinical and supply chain functions.
- Support Tech Transfer activities for new projects.
- Participate in quality audits to support GMP operations and regulatory requirements.
- Collaborate with Program Management, Manufacturing, Quality Control, Supply Chain, and attend meetings in support of relevant manufacturing programs and activities.
- Present data during departmental and cross-functional meetings as required.
- Perform additional activities as needed based on company requirements.
We Would Appreciate Hearing from You If:
- You hold a bachelor's degree or higher in a relevant scientific discipline – Bioinformatics, Biology, Biochemistry, Chemistry, or a related field.
- You have a minimum of years of experience in Quality and GxP biotechnology or pharmaceutical environments with supervisory responsibilities.
- You possess an understanding of GMP regulations and guidelines pertinent to early phase clinical programs, such as 21 CFR Part 210 and 211.
- You have extensive knowledge and experience with cGMP quality systems.
- You have experience using and/or managing eQMS, such as Veeva.
- You demonstrate strong interpersonal skills, the ability to work collaboratively in a team environment, attention to detail, and excellent problem-solving abilities.
- You exhibit strong teamwork, leadership, organizational, and communication skills.
- Experience in cell & gene therapy is advantageous.
At AmplifyBio , we are dedicated to fostering and empowering an inclusive community within our organization and the industry. We prioritize hiring and nurturing diverse teams of the most talented individuals from all backgrounds, experiences, and perspectives.
AmplifyBio is an equal opportunity employer, and we value diversity within our company. We do not discriminate based on race, color, citizenship status, national origin, ancestry, gender (including gender expression and 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 Enjoy Working Here:
We take the health and well-being of our employees seriously and continuously assess new ways to enhance our benefits, ensuring an exceptional workplace. From wellness programs to financial planning and legal assistance, we prioritize the care of our team.
- Health, Dental, and Vision insurance commencing on your first day at Amplify Bio .
- Competitive Compensation Package.
- We genuinely value work-life balance, supported by a FLEXIBLE PTO policy.
- Generous paid parental leave.
- Wellness and Self-Care Programs.
- 401(k) matching.
- Tuition Reimbursement.
- EAP/work-life support system.
- A vibrant work environment where every voice is valued.
- We are just beginning – more benefits are on the horizon.
- An Opportunity to Make a Difference.
When you join our team , you will engage in groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across various disciplines. The future for AmplifyBio is as promising as the synergy of our imaginations and actions, and we hold ourselves accountable for our choices and outcomes. We prioritize action, excellence, and, above all, the health and safety of our employees.
Compensation details: Yearly Salary
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