Jobs
>
New York City

    Sr./Specialist, Quality Assurance - New York, United States - AmplifyBio

    AmplifyBio
    AmplifyBio New York, United States

    1 week ago

    Default job background
    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
    AMECNew Albany, OH:
    AmplifyBios


    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).


    Youll Do Here:


    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.

    We Would Love to Hear from

    You If:
    Bachelors degree or higher in a relevant scientific discipline Bioinformatics, Biology, Biochemistry, Chemistry, or other relevant area.
    minimum of years of experience in Quality and GxP biotechnology or pharmaceutical environment with supervisory responsibilities.

    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.

    have extensive cGMP quality system knowledge and experience.
    using and or managing eQMS, such as Veeva.
    interpersonal skills, ability to work in a team environment, attention to detail and excellent problem resolution skills.
    teamwork, leadership, organization, and communication skills.
    Experience in cell & gene therapy is a plus.

    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.
    Dental, and Vision insurance that starts on your first day at

    AmplifyBio
    Compensation Package
    take work-life balance seriously and we back it up with a FLEXIBLE PTO policy.
    paid parental leave
    and Self-Care Programs
    match
    Reimbursement
    support system
    fun work environment where everyones voice matters.
    are just getting started More benefits on the way
    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.
  • OCI Global

    Quality Assurance

    3 weeks ago

    OCI Global Nederland, United States

    ABOUT OCI · OCI N.V. is a leading global producer and distributor of nitrogen products and methanol providing sustainable solutions to agricultural and industrial customers around the world. Our production capacity spans four continents and comprises approximately 16.1 million me ...

  • Sonata Healthcare

    Quality Assurance Director

    3 weeks ago

    Sonata Healthcare New City, United States

    **Sonata Care is one of the top insurance brokerages in the nation** and we are actively seeking a skilled Quality Assurance Director with experience in an quality assurance and customer service. This is an exceptional opportunity to grow within our rapidly expanding company. · - ...

  • SNA International

    Quality Assurance Analyst

    2 weeks ago

    SNA International Atlantic City, United States

    **_**This is a contingent opportunity_** · SNA International seeks a bright, collaborative Quality Assurance Analyst with a strong work ethic to join our team. SNA International's team works together in pursuit of our noble cause: _to build a safe and just world by empowering org ...

  • Children's Aid

    Quality Assurance Specialist

    2 weeks ago

    Children's Aid Manhattan, United States

    : · Harlem Family Services Center (317 Lenox Ave) · $ $65000 / year · **About Children's Aid**: For more than 160 years, Children's Aid has been able to help families change their lives by adapting to the ever evolving nature of poverty and constantly seeking improvement. We are ...

  • NYC Careers

    Quality Assurance Specialist

    2 weeks ago

    NYC Careers New York, United States

    **Quality Assurance Specialist**: · - Apply**Quality Assurance Specialist**: · - Agency: NYC HOUSING AUTHORITY · - Posted on: 05/15/2024- Job type: Full-time · Location · NYC-ALL BOROS · - Title Classification: Exam may be required · Department · Logistics & Inventory · - Salary ...

  • Trinity Technology Solutions

    Quality Assurance Tester

    1 week ago

    Trinity Technology Solutions New York, United States

    Working experience as System/Quality Assurance Tester with experience in all stages of Software Development Life Cycle (SDLC) · - Experience working with DevOps · - Analytical skills to describe and design complex business processes. · - Ability to understand and address all high ...

  • Red Lion Controls

    Quality Assurance Technician

    2 weeks ago

    Red Lion Controls York, United States

    About Us · Red Lion Controls, an HMS Group Member, is undergoing a period of significant change and growth. We empower industrial organizations around the world to unlock the value of data by developing and manufacturing innovative products and solutions to access, connect and vi ...

  • Adaptive Financial Consulting

    Quality Assurance Specialist

    1 week ago

    Adaptive Financial Consulting New York, United States

    **Quality Assurance Specialist** · **WE ARE**: · At Adaptive, we are a financial consulting firm that partners with capital, commodity, and digital market participants. We value differentiation through technology. Our experienced teams design and deliver complex front-office tech ...

  • Active Consulting Services LLC

    Quality Assurance Tester

    2 weeks ago

    Active Consulting Services LLC New York, United States

    **Title: -** **Quality Assurance Tester** · **Location: New York City, NY** · **Mandatory Experience required**: · - At least 7 years of experience in performing different types of software testing including web usability, functional, cross browser compatibility, database backend ...

  • Columbia University

    Quality Assurance Coordinator

    3 weeks ago

    Columbia University New York, United States

    Job Type: Officer of Administration · - Bargaining Unit: · - Regular/Temporary: Regular · - End Date if Temporary: · - Hours Per Week: 35 · - Standard Work Schedule: · - Building: · - Salary Range: $75,000 - $85,000 · - The salary of the finalist selected for this role will be se ...

  • Columbia University

    Quality Assurance Coordinator

    1 week ago

    Columbia University New York, United States

    Job Type: Officer of Administration · - Bargaining Unit: · - Regular/Temporary: Regular · - End Date if Temporary: · - Hours Per Week: 35 · - Standard Work Schedule: · - Building: · - Salary Range: $85,000 - $90,000 · - The salary of the finalist selected for this role will be se ...

  • Services For The Underserved, Inc.

    Quality Assurance Investigator

    1 week ago

    Services For The Underserved, Inc. New York, United States

    Min: USD $63,000.00/Yr. Max: USD $68,000.00/Yr. Position Overview: · The **Quality Assurance Investigator** is responsible for conducting investigations involving consumers/employees in the DD, BH, HS, TS and VT Divisions based on incidents/special issues. · - ** · SCOPE OF ROLE* ...

  • Seertech Systems

    Quality Assurance Tester

    3 weeks ago

    Seertech Systems New York, United States

    **Job Title**: Quality Assurance Engineer · **Location**: New York (Onsite) · **Work Mode**: Contract · **Experience Level**: 10+ years · **Maximum CTC**: $60,000 to $70,000 per annum · **Responsibilities**: · - Provide test strategy, estimation, and execute test cases. · - Work ...

  • Apex Ventures

    Quality assurance technician

    2 days ago

    Apex Ventures New Holland, United States

    Quality Assurance Technician / Specialist for our Quality Assurance Department with a focus on Mechanics (M/F/D) · FOR THOSE WITH A GOAL IN SIGHT · Ernst REINER GmbH & Co. KG is a medium-sized company located in Furtwangen in the Black Forest. REINER develops, produces, and distr ...

  • Skyline Ventures

    Quality Assurance Employee

    2 days ago

    Skyline Ventures York, United States

    Company pension plan ZVK · Occupational medical service · Germany ticket · Timely salary · Sports and fitness offers · Work-life balance · Using an app on your smartphone or tablet, you will conduct quality assurance in the city area and report any pollution or traffic hazards to ...

  • Major League Baseball Players Association

    Quality Assurance Manager

    14 hours ago

    Major League Baseball Players Association New York, United States

    MLB Players Inc. is looking for a **Quality Assurance Manager** who will be responsible for overseeing the MLBPI Quality Assurance team whose responsibility is to review MLB Players Inc. and MLBPA-licensed products for compliance with license agreements, accuracy, and depicting p ...

  • Graham Packaging Company

    Quality Assurance Supervisor

    2 days ago

    Graham Packaging Company Newark, United States

    Company Statement: Graham Packaging is a people, planet and values-based company and a leader in sustainable packaging manufacturing. From the kitchen to the laundry room, Graham Packaging is part of your everyday life. For employees at Graham, our Blue Culture is part of their e ...

  • Graham Packaging Company

    Quality Assurance Supervisor

    3 days ago

    Graham Packaging Company York, United States

    Company Statement: Graham Packaging is a leading manufacturer of sustainable packaging. From the kitchen to the laundry room, Graham Packaging is part of your everyday life. They're the kind of people you want as your friends and neighbors as well as your partners and suppliers. ...

  • GenesisTMG LLC

    Quality Assurance Tester

    1 week ago

    GenesisTMG LLC New York, United States

    **SENIOR TESTING SERVICES CONSULTANT** · Scope of Work The selected vendor will perform functional testing to: · - Verify compliance with applicable laws, regulations, industry standards, and best practices, reducing the risk of legal issues or penalties. · **Job Types**: Full-ti ...

  • Hawthorne Foods

    Quality Assurance Supervisor

    2 weeks ago

    Hawthorne Foods Hudson, United States

    A Day in the life of a Quality Assurance Supervisor: · A quality assurance job in a food plant is a critical role that ensures the safety, quality, and compliance of food products. The role involves monitoring production processes, verifying that the final product meets specific ...