Quality Assurance Specialist

Genezen

Posted: about 2 months ago

Company Website
https://remoteOK.com/r...
Position type
full time
Job source
Remote ok
Category
programming
Remote
Yes
Salary
---
Job location
Indianapolis, Indiana, United States
About

PURPOSE

Be an integral part of the Quality team by providing quality assurance oversight and leadership to operations, manufacturing, and quality control activities.  Address terms of systems quality and conformance to regulations and Genezen quality policies/procedures. Help in the development of QA people and teams.

ESSENTIAL JOB FUNCTIONS / DUTIES

  • Assist in the maintenance of quality systems including a robust and continuous quality improvement system compliant with GMP and applicable to cell and gene therapy products used in early phase clinical trials.
  • Quality subject matter expert, providing training, oversight, collaboration and approval on all Quality Management Systems activities and outputs, including but not limited to electronic change control, quality events, deviation investigations and CAPAs in Veeva Vault QMS.
  • Develops and prepares quality management system metrics for Quality Management Review.
  • Provides support in the preparation, conduct, and follow-up activities associated with regulatory inspections and client audits
  • Quality review and approval of validation protocols, executed validation packages, and summary reports.
  • Quality partner on client tech transfer teams to successfully onboard new clients and new projects, including materials, suppliers, equipment, processes, master records, and additional support required.
  • Support internal and external (supplier) audit program as a qualified auditor, including writing audit reports and following up on corrective actions and commitments. 

SPECIAL JOB REQUIREMENTS

  • Adaptability required as work schedule may change based on business needs
  • Criminal background check and drug screen required
  • Other duties as assigned

KNOWLEDGE, SKILLS & EXPERIENCE

EDUCATION / CERTIFICATIONS / LICENSES

Essential/Desired

Bachelor’s degree in science or related field

Essential

In depth knowledge of cGMP FDA and EU regulations, and ICH guidelines

Essential

Familiar with regulatory guidelines for early phase clinical trials

Essential

Certified Quality Auditor or Certified Pharmaceutical GMP Professional

 

Desired

ON-THE-JOB EXPERIENCE

 

Minimum of 3-5 years of working experience in Pharma, Biologics, CGT industry in a Quality Assurance role

Essential

Previous experience reviewing and approving quality system reports – deviation, CAPA, change control

Essential

Previous experience reviewing validation protocols and reports

Desired

Previous experience with product/process tech transfer

Desired

Previous experience in the field of Gene Therapy

Desired

Previous experience at a fast-paced CDMO.

Desired

SKILLS / ABILITIES

 

Manage multiple projects, set priorities, and work in fast-paced environment

Essential

Communicate confidently and effectively with management, peers, and key stakeholders

Essential

Demonstrate effectiveness in task completion, decision-making, empowerment of others, and problem solving

Essential

PHYSICAL DEMANDS
While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

  • Occasionally exposed to loud noise levels
  • Position can be a combination of remote and on-site
  • Regularly sit for long periods of time

Movement

  • Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
  • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

  • Frequently lift and/or move up to 10 pounds
  • Occasionally lift and/or move up to 25 pounds

Vision

  • Frequently utilize close vision and the ability to adjust focus

Communication

  • Frequently required to communicate by talking, hearing, using telephone and e-mail


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