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Quality Assurance Specialist I NBPI021

Employer
Nitto BioPharma Inc.
Location
San Diego, CA, United States
Start date
Jul 19, 2019

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Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Beach
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Job Details

Position: Quality Assurance Specialist I job code NBPI021

Reporting to: Senior Director, QA

Core Competencies
  • Strong organizational skills; ability to manage projects, partners and CSPs, multi-task; work well with others across different disciplines and levels in a professional setting; flexible and adaptable to changing priorities
  • Must be able to multitask and be flexible to take on varying activities
  • Must have effective time management and communication skills (verbal and written)
  • Must have the ability to maintain confidentiality
  • Proficient in Microsoft Office Suite (e.g., Outlook, Word, Excel, PowerPoint)
  • Works well independently and in teams
  • Coordinates activities with other personnel, focuses on building a strong department
  • Excellent writing and grammar skills for scientific papers and reports
  • Task-oriented, works with sense of Crisis, Speed and Communication

Responsibilities

Document Control
  • Serve as Key User for a Corporate Electronic Document Management System (eDMS).
  • Responsible for maintaining internal Quality Assurance Systems SOP and Policy documentation, help to write related SOPs
  • Manage the Document Control Room and ensure all required GXP documents are properly filed, the room is maintained in a neat and orderly manner
  • Review draft protocols and reports, work instructions, draft SOPs, etc., and help to format, correct grammar and typographical errors.
  • Ensure all SOPs, Forms, and Policies are in compliance with internal documentation rules and Periodic Review procedures
  • Act as lead or key team member for moving documents into an eDMS system
  • Help to organize the electronic Quality directories throughout the different network drives outside of the eDMS
  • Assist personnel with technical report management, and IND documentation management
  • Perform quality function in eDMS (Workflow Coordinator in all GXP workflows to manage the format of the document and determination of workflow roles)
  • Oversee and coordinate offsite document storage

    Training
  • Conduct or help conduct periodic training of staff in various documentation practices and train new personnel in operation and use of the eDMS
  • Train company personnel to author, edit, revise, approve procedures
  • Manage training records for employees, maintain training records for organization in eDMS and hardcopy

    Clinical Supplies
  • Assist with clinical supply coordination, product shipments; prepare necessary documentation
  • Maintain shipping log to track all drug substance and drug product shipments of toxicology and GXP materials
  • In conjunction with QA Director, create Master Labels, address discrepancies, deviations and CAPAs for clinical supplies

    Other
  • Additional tasks as required, assist and support QA Head as needed


Education and/or Experience:
  • Bachelor's degree in Biomedical, Biology, Chemistry or Molecular Biology in Quality Systems and Quality Assurance in Pharmaceutical or allied field, preferred, but not required.
  • Three to five years experience with paper-based and electronic Document Management Systems (eDMS) in a regulated environment


Physical Job Requirements:
  • Office/Lab environment. Lifting up to 20 pounds may be required. While performing the duties of this job, the employee is regularly required to use their hands and fingers to operate a computer keyboard, mouse, and telephone keypad or to write, as well as talk and hear. They are required to stand, walk or sit, reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.


  • Disclaimer: This job description reflects management's assignment of essential job duties; and nothing in this herein restricts management's right to assign or reassign duties and responsibilities to this job at any time.


About Nitto BioPharma Inc.:

Description
Company Overview:
Nitto BioPharma, Inc., is a clinical stage biopharmaceutical company located in San Diego focused on the discovery and development of novel RNA-based therapeutics for intractable diseases. Clinical assets include a liver fibrosis program (BMS-986263/ND-L02-s0201), partnered with BMS and in Phase 2 in the US, an Idiopathic Pulmonary Fibrosis program (ND-L02-s0201) in Phase 2 in the US and Europe and Oncology program (NBF-006) in Phase 1 in the US . Nitto BioPharma is also advancing several programs for intractable diseases including Oncology and fibrosis.

Company

Nitto BioPharma, Inc. is a clinical stage biopharmaceutical company located in San Diego focused on the discovery and development of novel RNA-based therapeutics for intractable diseases. Nitto BioPharma offers unique drug and RNA delivery solutions by designing novel biodegradable drug delivery systems with the ability to target specific cells and efficiently deliver the cargo into the cells. Clinical assets include two Phase 2 clinical programs, a first-in-class drug for the treatment of fibrotic diseases of the liver (with Bristol-Myers Squibb), and idiopathic pulmonary fibrosis, as well as a Phase 1 oncology program to treat non-small cell lung cancer.  
Nitto BioPharma's mission is to develop and deliver innovative life-transforming therapies for patients with unmet medical needs. Leveraging the long-standing success and track record of Nitto Denko Corporation (Nitto), Nitto BioPharma has created a new and efficient business unit that allows pharmaceutical products to be brought to market at a fast pace. Our long-term vision and unparalleled, multi-disciplinary team of researchers from all over the globe make Nitto BioPharma a vibrant and exciting work environment.

Nitto BioPharma is a key asset of Nitto. Since its establishment in 1918, Nitto has created over 13,500 products based on its core technologies and has contributed to customers' value creation with innovative ideas. The core of Nitto's life science business consists of contract manufacturing and drug discovery.

Company info
Website
Phone
760-435-7058 (HR)
Location
10618 Science Center Drive
 San Diego
California
92121
United States
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