Sr. GCP Quality Specialist

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Good Manufacturing Practice (GMP), Good Clinical Practice (GCP)
  3. United States
New York, USA
Posting date: 05 Apr 2021
QA.JL.36616A

Proclinical is currently recruiting for a Senior GCP Quality Specialist with a global clinical testing service located remotely. As the Senior GCP, you will promote and support a culture of audit readiness within ACM Global Laboratories.

Job Responsibilities:

  • Responsible for the development, implementation and on-going continuous improvement of the site's Quality Systems.
  • Support vendor qualifications, and hosts and conducts audits (e.g., customer, internal, vendor and regulatory inspections).
  • The Sr. QA Specialist effectively conduct and support Quality Issues (QI) and manage Corrective Actions & Preventive Actions (CAPA) and Change Controls (CC).
  • Responsible for developing/maintaining Quality System Standard Operating Procedures (SOPs) and performing the QA review/approval of the site's SOPs and a wide variety of Good Clinical Practice (GCP) related documents, including laboratory equipment and method validations/analytical reports.
  • Serve as a frequent inter-organizational contact and represent the department on project teams, as well as provides leadership to the site for GCP related training.
  • Supports generation and reporting of Key Quality Performance Indicators for the site's Quality Systems.

If you are having difficulty in applying or if you have any questions, please contact Matt Phelan at (+1) 646-779-7968 or m.phelan@proclinical.com.

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

Proclinical Staffing is an equal opportunity employer.

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