Quality Assurance (QA) Specialist II/Sr. Specialist
Company: Encoded Therapeutics Inc.
Location: San Francisco
Posted on: November 11, 2019
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
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.
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
- 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
- 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
- Bachelor's or Master's Degree in relevant disciplines in life
- 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
- Outstanding planning, organization and multitasking
- Must be a team player and exhibit a willingness to meet project
- An extremely high degree of attention to detail.
- Strong documentation skills.
- Responsible and accountable for non-compromising high ethical
- Ability to translate complex issues into meaningful
- Experience with QMS software platforms is a plus.
- Experience with AAV or gene therapies is a plus.
- Comprehensive benefits package, including competitive employer
- 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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