Leading GxP System Specialist

1 day ago


New Albany, Ohio, United States AmplifyBio Full time

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.

We are seeking to hire a Leading GxP System Specialist to join our growing team. The role will be responsible for leading GxP system implementation and providing data integrity and regulatory guidance and oversight throughout the system lifecycle at AmplifyBio. This includes monitoring/maintaining/supporting health, data integrity and regulatory compliance of GxP computerized systems in conformance with all applicable policies and SOPs.

Key Responsibilities:

  • Maintain technical SOPs and validation artifacts required to implement and maintain computerized systems
  • Lead/manage computerized system validation activities for new implementations or enhancements to existing systems
  • Perform and author data integrity and GxP risk assessment to ensure effective requirements are captured and controls are in place to meet global regulatory requirements for GxP systems

Requirements:

  • Minimum BA/BS in a life sciences or engineering/computer science or similar scientific discipline (advanced degree preferred)
  • A minimum of 5 years' experience and in-depth knowledge of data integrity requirements and GxP computer system validation, and Part 11 requirements in a Pharmaceutical or Biotech environment including understanding software development and supporting validation IT systems in manufacturing and/or laboratories
  • In-depth understanding of regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820 and local regulations for assigned areas

Salary Range: $90,000 - $120,000 per year



  • New Albany, Ohio, United States AmplifyBio Full time

    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 to a preclinical CRO performing safety efficacy and toxicology studies.The company is comprised of three distinct business units: ADOC (South San Francisco, CA)– Amplify's Discovery,...


  • New Albany, Ohio, United States AmplifyBio Full time

    Senior Systems Analyst, QIT Job Description:AmplifyBio is seeking a highly skilled Senior Systems Analyst, QIT to join our team in New Albany, OH. As a critical member of the Quality IT (QIT) department, you will lead the implementation and maintenance of GxP computerized systems, ensuring compliance with all applicable regulations.Key...


  • New Albany, Ohio, United States Mount Carmel Health System Full time

    Job Summary:We are seeking a highly skilled Dining Services Specialist to join our team at Mount Carmel Health System. In this role, you will be responsible for preparing and serving high-quality meals to patients, staff, and visitors.About the Role:Prepare and cook large quantities of food according to recipes and dietary guidelines.Maintain a clean and...


  • New Albany, Ohio, United States M.C. Dean, Inc. Full time

    Electrical Maintenance Systems SpecialistAbout M.C. Dean, Inc.M.C. Dean, Inc., a leading provider of electrical engineering and construction services, seeks an experienced Electrical Maintenance Systems Specialist to join our team. The successful candidate will be responsible for maintaining and ensuring the reliable operation of all electrical systems...


  • New Albany, Ohio, United States Mount Carmel Health System Full time

    OverviewMount Carmel Health System, a leading healthcare provider in Central Ohio, offers an exciting opportunity for a Skilled Care Specialist to join our team.CompensationThe estimated annual salary for this role is $42,000 - $55,000, depending on experience.Job SummaryWe are seeking a dedicated and compassionate individual to provide patient care in an...


  • New Albany, Ohio, United States Pkaza Full time

    Job OverviewWe are seeking a highly skilled Electrical Commissioning Engineer to join our team at Pkaza LLC. As a critical systems specialist, you will be responsible for ensuring the smooth operation of large facility projects.


  • New Albany, Ohio, United States Mount Carmel Health System Full time

    Job SummaryThe Food Preparation Specialist at Mount Carmel Health System is a key role in our culinary team, responsible for preparing and serving high-quality food to patients, staff, and visitors. As a member of our team, you will have the opportunity to work in a fast-paced environment with a focus on customer satisfaction.About Mount CarmelMount Carmel...


  • New Philadelphia, Ohio, United States Battle Motors Full time

    Job DescriptionWe are seeking an Electrical Systems Specialist to lead our team of electrical technicians. The ideal candidate will have 5+ years of experience in electrical systems troubleshooting and repairing.Key ResponsibilitiesLead a team of electrical technicians in diagnosing and repairing high and low voltage electrical subsystems.Assign and direct...


  • New Philadelphia, Ohio, United States Battle Motors Full time

    Battle Motors, a leading manufacturer of heavy-duty work trucks, is seeking an Electrical Systems Lead to join our team.Estimated Salary: $85,000 - $110,000 per yearJob Description:We are looking for a skilled and experienced electrical systems professional to lead a team of electrical technicians in diagnosing and repairing high and low voltage electrical...


  • New Albany, Ohio, United States Beacon Orthopaedic Partners MSO LLC Full time

    Job DescriptionWe are seeking a highly skilled and detail-oriented Durable Medical Equipment (DME) Specialist to join our team at Beacon Orthopaedic Partners MSO LLC. This full-time position is responsible for coordinating and advising on all aspects of the DME program, including insurance and billing.Key Responsibilities:Coordinate and advise on all aspects...


  • New Philadelphia, Ohio, United States Battle Motors Full time

    Job OverviewBattle Motors is a leading manufacturer of electric vehicles, and we are seeking an experienced Electrical Systems Lead Technician to join our team. This role is based in New Philadelphia, Ohio.We offer a competitive salary package, including an estimated annual salary of $95,000, depending on experience.About the RoleThe successful candidate...


  • New Albany, Ohio, United States American Regent, Inc. Full time

    Job DescriptionWe are seeking an experienced Senior Quality Systems Manager to oversee our Quality investigation and CAPA related activities. This role will involve interacting with various departments, including manufacture of sterile injectables, laboratories, facilities/engineering, validations, R&D, and materials at multiple sites in the Columbus, Ohio...


  • New Albany, Ohio, United States Pharmavite Full time

    OverviewPharmavite is committed to delivering exceptional products and services that meet the evolving needs of our customers. As an Operational Excellence Specialist, you will play a critical role in driving process improvements and ensuring the highest level of quality across our operations.**Salary:** $43,153 - $64,678 per annum**Job Description:**As an...


  • New Albany, Ohio, United States Brooksource Full time

    About the Role: Brooksource is seeking a skilled Data Center Infrastructure Specialist to join our rapidly expanding team.Job Summary: We are looking for a highly motivated and experienced individual to maintain the hardware infrastructure of the latest cloud computing server technologies.Key Responsibilities:Maintain data center hardware, including servers,...


  • New Albany, Ohio, United States PIC Companies Full time

    PIC Group, Inc. is seeking a highly skilled Electrical Project Coordinator Specialist to support the construction of several new data center campuses across the US.The ideal candidate will have extensive technical experience and a proven track record in managing complex projects involving electrical systems. They will be responsible for ensuring that all...


  • New Albany, Ohio, United States Giant Eagle Full time

    About the RoleWe are seeking a skilled Pastry Production Specialist to join our team at Giant Eagle. As a key member of our bakery department, you will be responsible for producing high-quality baked goods and delivering exceptional customer service.Key ResponsibilitiesBake prepared products using established recipes and guidelines.Prepare and fry donuts...


  • New Albany, Ohio, United States American Electric Power Full time

    About the RoleWe are seeking a highly skilled NERC Compliance Specialist to join our team at American Electric Power. This role will play a critical part in ensuring compliance with NERC reliability standards, collaborating with various business units to develop and maintain processes and procedures, and participating in periodic audits.Key...


  • New Albany, Ohio, United States hims & hers Full time

    Optimize Pharmacy and Fulfillment OperationsHims & Hers Health, Inc., a leading health and wellness platform, is revolutionizing telehealth for providers and patients. As an Industrial Operations Specialist, you will optimize processes, improve efficiency, and maximize productivity in our pharmacy and fulfillment operations.Key Responsibilities:Analyze...


  • New Albany, Ohio, United States Mount Carmel Health System Full time

    Job Title: CookJob Summary:Job Summary: Mount Carmel Health System is seeking a skilled Cook to join our team at our Mount Carmel location. The Cook will be responsible for preparing and cooking food for patients, cafeteria, and catering services. The ideal candidate will have a strong understanding of food preparation, cooking techniques, and safety...


  • New Albany, Ohio, United States EMH&T Full time

    Job Title: CAD Design Specialist - Site DevelopmentAbout Us:EMH&T is a leading provider of civil engineering services in Columbus, OH.Estimated Salary: $65,000 - $80,000 per yearJob Description:We are seeking a skilled CAD Design Specialist to join our site development team. As a key member of our team, you will be responsible for drafting technical...