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Quality Assurance (QA) Specialist II/Sr. Specialist

Company: Encoded Therapeutics Inc.
Location: San Francisco
Posted on: November 11, 2019

Job Description:

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit .
We are recruiting a QA Specialist/Sr. QA Specialist to join our team. This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology. The successful candidate will work well across multiple projects in a fast-paced and dynamic environment.
Responsibilities
This position is part of the Quality group and will be responsible for the design, development, and implementation of the company's quality management systems (QMS). The responsibilities include:

  • Represents QA in functional team meetings; provides guidance and recommendations in alignment with regulatory requirements.
  • Maintains updated and relevant knowledge of the GMP landscape, regulations, and guidelines.
  • Author and revise QA related standard operating procedures and provides guidance for generation, review, and approval of the process, equipment, test method, and other SOPs.
  • Supports laboratory quality activities for analytical development and operations.
  • Reviews and approves all GMP related documentation including internal and external protocols, reports, test records, batch records, etc.
  • Assists in the development and implementation of various quality systems, policies, and procedures.
  • Reviews and approves change controls related to the implementation or revision of process, assay qualifications, methods, and/or equipment changes.
  • Manages a companywide training program.
  • Assists in the implementation and management of the nonconformance and CAPA systems. Provides input for CAPAs and manages CAPA closure timelines.
  • Support QA in complex quality investigations/deviations and author investigation reports.
  • Oversees execution and completion of CA or PA activities.
  • Identifies opportunities for improvement, and drives continuous improvement initiatives.
  • Maintains equipment files, approves IQ/OQ/PQ protocol and reports, and ensures all applicable documentation is archived.
  • Manages and maintains QA logs, logbooks, databases, etc.
  • Trends and reports key quality metrics to the leadership team.

    Requirements
    • Bachelor's or Master's Degree in relevant disciplines in life sciences.
    • 2-5 years (Specialist II) and 5+ years (Sr. Specialist) of QA experience in a pharmaceutical or therapeutic environment; GMP experience is required.
    • Strong understanding of applicable regulatory requirements and guidance documents (21 CFR, USP, EP, ICH).
    • Ability to thrive in a fast-paced dynamic environment with the ability to maintain objective and autonomous as it relates to quality and compliance.
    • Demonstrated knowledge of quality management systems, processes, and procedures.
    • Significant protocol writing and revision experience.
    • Strong interpersonal and communication skills; written and oral.
    • Outstanding planning, organization and multitasking skills.
    • Must be a team player and exhibit a willingness to meet project timelines.
    • An extremely high degree of attention to detail.
    • Strong documentation skills.
    • Responsible and accountable for non-compromising high ethical standards.
    • Ability to translate complex issues into meaningful recommendations.
    • Experience with QMS software platforms is a plus.
    • Experience with AAV or gene therapies is a plus.
      Benefits
      • Comprehensive benefits package, including competitive employer premium contributions
      • Meaningful stock option grants
      • PTO, sick time and holiday pay
      • Generous Parental Leave program
      • Pre-tax medical and dependent care programs
      • LTD, Life, and AD&D
      • Professional development opportunities
      • Team-building events
      • Fully stocked kitchen
        Encoded Therapeutics, Inc. is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics.Encoded encourages applicants of all ages. If you need assistance or an accommodation due to a disability, you may call us at +1 .

Keywords: Encoded Therapeutics Inc., San Francisco , Quality Assurance (QA) Specialist II/Sr. Specialist, Other , San Francisco, California

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