QA Compliance Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Good Clinical Practice (GCP)
  3. United States
North Chicago, USA
Posting date: 28 Oct 2020
This vacancy has now expired

Proclinical is currently recruiting for a QA Compliance Specialist with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

  • General understanding of US and international regulations for quality systems and compliance
  • Batch Record Review, experience with Master Batch Records preferred.
  • Incoming material release
  • Manufactured material release (mainly starting materials/Intermediates)
  • Material number approvals
  • Area metrics preparation
  • Material handling, inventory management in SAP

Skills and Requirements:

  • Bachelors' Degree in Chemical Engineering, Chemistry or Industrial Biotechnology.
  • Attention to detail
  • Knowledge of GDP (good documentation practices)
  • Knowledge of GMP (good manufacturing practices) experience
  • Individual will be required to use an electronic inventory system and non-conformance system and must be able to quickly learn how to navigate.
  • Good communication skills (Individual will have to approach other functional areas and obtain appropriate corrections to documents).

Experience in a manufacturing plant for Active Pharmaceutical Ingredients (API).

  • SAP experience
  • Trackwise experience
  • Experience in Quality Assurance, prefer healthcare industry or experience in quality function

If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.

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.