Sr. Quality Systems Specialist

2 months ago

West Jefferson, United States Amplifybio, LLC Full time
Job DescriptionJob 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 ASET West Jefferson, OH: AmplifyBio’s safety, efficacy, and toxicology unit (ASET) was launched as a preclinical CRO that spun out of Battelle in 2021 to address the changing needs of commercial organizations developing modern therapeutics. AmplifyBio brings decades of experience to accommodate a wide variety of GLP and non-GLP studies in all in vivo models and dose routes. Among the investments that AmplifyBio has made to empower preclinical assessments of advanced therapies is building a new state-of-the-art analytical laboratory to include molecular and immunological assays that assess critical safety and efficacy indicators for cell and gene therapies during preclinical studies

AmplifyBio is seeking to hire a Sr. Quality Systems Specialist to join our growing team

The Sr. Quality Systems Specialist is responsible for providing oversight and guidance for the execution of quality processes within the Quality Management System (QMS) as part of the QS group. The Sr. Quality Systems Specialist will ensure that all quality processes (Deviation/CAPA, Training Administration, Document Control, etc.) are conducted in compliance with applicable regulations, client requirements, and AmplifyBio procedures and policies. They support working relationships with other department staff and personnel to drive operational efficiencies a continuous improvement mindset.

What You’ll Do Here:

  • Guides the execution of Quality Event Reporting, Investigations, Corrective and Preventive Action (CAPA) program and Change Control processes.
  • Supports the Quality Review Board (QRB) for quality event awareness, discussion, and action plan development, including trend analysis and reporting.
  • Participating in the planning, development, creation, and implementation of training programs
  • Maintaining up-to-date, correct, and accurate training records, such as trainee lists, schedules, attendance sheets, and so on
  • Oversees the controlled document process using the electronic Quality Management System (Veeva QualityDocs)
  • Prepares Document Change Controls and monitors through completion.
  • Acts as a Leader of Influence and a trusted Point of Contact for Operations staff.
  • Maintains a thorough knowledge of all applicable regulations and AmplifyBio policies.
  • Supports project deliverables, discusses project quality with management.
  • Ensures QS procedures, manuals, and policies are followed.
  • Supports the quality processes training program for CRO Operations, promoting organization awareness to foster a quality culture.
  • Assists with implementation and maintenance of the electronic QMS, providing business administration oversight and engagement where needed.
  • May assist QAU staff with assigned audits, critical phase, and facility inspections where necessary.
  • Demonstrates ownership of assignments with accountability and instills trust in the project team.
  • Proven risk management skills including mitigation strategies.
  • Established internally as a Quality Management Systems subject matter expert and amongst peers as a leader in the organization.
  • Identifies compliance gaps and actively drives process/continuous improvement efforts to minimize risk to the organization.
  • Drives change management using effective strategies and own skills to facilitate organizational change initiatives.

We Would Love to Hear from You If:

  • Bachelor’s Degree in a related field; 8 years of experience in a quality assurance program and proven communication skills; or an equivalent combination of education and/or experience in a related field.
  • Strong team player with the ability to work across multiple disciplines.
  • Effective communicator (verbally and in writing) and self-starter.
  • Ability to handle multiple projects simultaneously.
  • Must be able to do work independently, recognizing what needs to be done and accomplishing it with minimal supervision.

Desired But Not Required:

  • Experience establishing a document control process.
  • Experience supporting operational excellence and continuous improvement through investigational skills, CAPA, effectiveness checks, and quality event trending/reporting.
  • Experience working as a quality professional under 21 CFR 58 and 21 CFR 11.
  • Experience with Veeva Quality Suite Platform.

At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. This is why 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 (did we mention we have an onsite gym with state-of-the-art equipment and ping pong table?), 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 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
  • 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.

  • Sr. Specialist Systems Engineer 1

    3 weeks ago

    West Valley City, United States L3Harris Technologies Full time

    Job Title: Sr. Specialist, Systems EngineerJob Code: 10683Job Location:Salt Lake City, UTJob Schedule: 9/80Job Description:L3Harris’ Communication Systems segment is currently seeking a Senior Specialist Systems Engineer to join our team. This position will be based at our Salt Lake City facility. Position Overview:This person will be responsible for...

  • Sr. Systems Engineer

    2 days ago

    West Pittsburg, United States Diverse Lynx Full time

    (phone number removed) Sr. Systems Engineer Pittsburg, PA Philips TP / FTE Any Visa $55/hr-60/hr and 100k/Annum -120k/Annum 7+ Years Sr. Systems Engineer((phone number removed)) Mandatory Skills: Systems Engineering for Electromechanical Medical Devices, InCose certification ISO 13485, ISO 14971, IEC 62304, Usability for Medical...

  • PS Billing Specialist, Sr

    1 week ago

    West Valley City, United States University of Utah Full time

    University of Utah PS Billing Specialist, Sr SALT LAKE CITY , Utah Apply Now This position is responsible for following patient accounts through the entire billing process from eligibility to completion of payment process. Providing medical billing and collection processes by verifying eligibility and benefits, obtaining preauthorization, entering...

  • Sr./Scientist Analytical Sciences

    6 days ago

    West Jefferson, 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...

  • Sr./Scientist Analytical Sciences

    2 months ago

    West Jefferson, 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...

  • Systems Administration Specialist

    2 weeks ago

    Jefferson City, United States State of Missouri Full time

    Job Location: The office for this position is located at the Harry S. Truman State Office Building, 301 W High Street, Jefferson City, MO. 65101. Why you'll love this position: The System Administration Specialist's role is to ensure the stability, integrity, and efficient operation of information systems that support the State of Missouri's core...

  • Systems Administration Specialist

    4 weeks ago

    Jefferson City, United States State of Missouri Full time

    Job Location: The office for this position is located at the Harry S. Truman State Office Building, 301 W High Street, Jefferson City, MO. 65101. Why you'll love this position: The System Administration Specialist's role is to ensure the stability, integrity, and efficient operation of information systems that support the State of Missouri's core...

  • 20040 - SAP HCM Sr. Business Systems Analyst

    2 weeks ago

    West Point, United States Hyundai Autoever America Full time

    Job DescriptionJob Description20040 - SAP HCM Sr. Business Systems Analyst West Point, GA (onsite)CBU:  KaGAPurpose of the Position:The SAP HCM Sr. Business Systems Analyst role at Hyundai/Kia Motors Manufacturing involves leading HCM (Human Capital Management) solutions, supporting business systems like SAP HR and SuccessFactors, and collaborating with...

  • 20040 - SAP HCM Sr. Business Systems Analyst

    1 week ago

    West Point, United States Hyundai AutoEver America Full time

    20040 - SAP HCM Sr. Business Systems Analyst West Point, GA (onsite) CBU: KaGA Purpose of the Position: The SAP HCM Sr. Business Systems Analyst role at Hyundai/Kia Motors Manufacturing involves leading HCM (Human Capital Management) solutions, supporting business systems like SAP HR and SuccessFactors, and collaborating with Korea HQ to enhance and...

  • 20040 - SAP HCM Sr. Business Systems Analyst

    1 month ago

    West Point, United States Hyundai Autoever America Full time

    Job DescriptionJob Description20040 - SAP HCM Sr. Business Systems Analyst West Point, GA (onsite)CBU:  KaGAPurpose of the Position:The SAP HCM Sr. Business Systems Analyst role at Hyundai/Kia Motors Manufacturing involves leading HCM (Human Capital Management) solutions, supporting business systems like SAP HR and SuccessFactors, and collaborating with...

  • Sr. Systems Engineer

    5 days ago

    West Valley City, United States Kesta IT Full time

    Come build, innovate, disrupt, and thrive! K?STA I.T. is actively seeking a Sr. Systems Engineer for an immediate long-term contract position. Are you on the lookout for a contract opportunity that offers stability and job security over the next 2+ years with the chance to make a significant impact? If you're eager to contribute to a thriving and stable...

  • Operations Quality Manager

    4 days ago

    Jefferson, United States Generac Power Systems Full time

    Company Generac Power Systems Name Operations Quality Manager Req # 65279 Employment Type Full Time Shift 1stWe are a team of hardworking builders and doers who share a passion for innovation and a desire to outpace others in our field. We push boundaries and seek opportunities for our products and people to evolve. As an inclusive workplace, we keep equity...

  • Operations Quality Manager

    5 days ago

    Jefferson, United States Generac Power Systems Full time

    Company Generac Power Systems Name Operations Quality Manager Req # 65279 Employment Type Full Time Shift 1st We are a team of hardworking builders and doers who share a passion for innovation and a desire to outpace others in our field. We push boundaries and seek opportunities for our products and people to evolve. As an inclusive...

  • Quality Associate/Data Entry Specialist

    5 days ago

    West Union, United States HNM Systems, Inc. Full time

    Job DescriptionJob DescriptionIdentified as one of the top 100 fastest growing private businesses in San Diego by the SD Business Journal, HNM Systems is a rapidly growing, people-driven Communication Information and Emerging Technology staffing and consulting firm.DescriptionBe a part of shaping our future. In the midst of rapidly growing populations,...

  • Quality Assurance Specialist/NDA QA Specialist

    3 days ago

    West Paducah, United States Four Rivers Nuclear Partnership LLC Full time

    Job DescriptionJob DescriptionNondestructive Assay Quality Assurance SpecialistReports to the FRNP Quality Assurance/Quality Control (QA/QC) Manager for oversight of the Nondestructive Assay (NDA) Program. Under limited supervision, performs quality assurance support for the QA/QC team in the area of NDA as a primary function. Other duties may be assigned as...

  • Sr Life Claims Specialist

    1 month ago

    West Des Moines, United States Farm Bureau Financial Services Full time

    Sr Life Claims Specialist Do you desire to make a difference? Are you a flexible team player, a hard worker and a quick learner looking for a new opportunity where each day is different? Do you have past life and annuity experience and a strong customer service mindset? If so, this could be a great opportunity for you! Who We Are:  At Farm Bureau...

  • Systems/Reliability Operations Engineer

    4 days ago

    West Jefferson, United States Battelle Memorial Institute Full time

    Battelle delivers when others cant. We conduct research and development, manage national laboratories, design and manufacture products and deliver critical services for our clientswhether they are a multi-national corporation, a small start-up or a government agency. We recognize and appreciate the value and contributions of individuals with diverse...

  • Sr. Benefits Specialist

    2 weeks ago

    West Harrison, United States Jackson Lewis LLP Full time

    Focused on labor and employment law since 1958, Jackson Lewis P.C. s 950+ attorneys located in major cities nationwide consistently identify and respond to new ways workplace law intersects business. We help employers develop proactive strategies, strong policies and business-oriented solutions to cultivate high-functioning workforces that are engaged,...

  • 20207 - Sr. Systems Administrator

    2 weeks ago

    West Point, United States Hyundai AutoEver America Full time

    20207 - Sr. Systems Administrator West Point, GA CBU:  TransSeat Purpose of the position: Provides technical leadership and is responsible for establishing the direction for maintenance, standards, life-cycle management, design and implementation approaches for the company’s servers and/or related virtual infrastructure. Creates, evaluates and implements...

  • 20207 - Sr. Systems Administrator

    1 month ago

    West Point, United States Hyundai Autoever America Full time

    Job DescriptionJob Description20207 - Sr. Systems AdministratorWest Point, GACBU:  TransSeatPurpose of the position:Provides technical leadership and is responsible for establishing the direction for maintenance, standards, life-cycle management, design and implementation approaches for the company’s servers and/or related virtual infrastructure. Creates,...