QMS Associate

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United States
New York
Posting date: 19 Jul 2019

Proclinical is currently seeking a QMS Associate for a neuroscience company located in New York, NY. Successful candidate will be responsible for executing functions of the company's Quality Management System at the direction of the Quality Assurance Associate Director.

Job Responsibilities:

  • Reviewing and approving batch records, analytical data, investigations/deviations, corrective and preventive actions, changing management, complaints and specifications.
  • Providing input/information for internal or external audits and regulatory inspections.
  • Participating in training activities that may include providing information to trainers or actual instruction for trainees.
  • Participating in Pre-Approval Inspection readiness activities.
  • Supporting and providing back up to the document and training coordinator as needed.
  • Providing support for annual quality and product reviews related to internal and external deviations; CAPAs; and associated change management as required.
  • Drafting/authoring deviation, CAPA, and other quality documents as applicable and following through to completion.
  • Participating in the material review board process.
  • Representing QA to assure that applicable internal departments are informed of issues related to any deviations, investigations, CAPAs and change management.
  • Supporting client/partner audits or regulatory inspections related to Quality Management, Manufacturing, Materials, and Packaging/Labeling Systems.
  • Assisting in the oversight of Manufacturing, Materials Management and Packaging/Labeling Systems. This includes applicable quality activities at Contract Manufacturing Organizations of Drug Substance (DS), Drug Product (DP) and testing facilities.

Skills and Requirements:

  • This position may require minimal travel; no more than 10 percent.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Ysabel Capitan at (+1) 347-293-1123 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.