QA Compliance Specialist

Highly Competitive Salary
  1. Permanent
  2. Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP)
  3. United States
North Chicago, USA
Posting date: 20 May 2021

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

Job Responsibilities:

  • Creates and maintains data, documentation and systems to track, monitor, and support the supplier management program.
  • Ensures integrity, accuracy, consistency and completeness of area of responsibility.
  • Corresponds with suppliers regarding inquiries and completion of documentation required by company policies and procedures, such as quality agreements, expectations, etc.
  • Uses discretion in escalating unusual product performance issues, collaborates with other functional areas to discuss and resolve. Participates in product improvement teams, strategic program development, risk assessments and other analytical teams responsible for the improvement of products and regulatory issues.
  • This position requires a very high degree of technical competence and communicative ability in order to receive, evaluate, investigate and respond to internal customers' questions and requests.
  • Interfaces with several multi functional areas, such as Research and Development, Quality Assurance, Legal, and Purchasing to document, review, and resolve supplier performance issues.
  • Creates supplier exception report rate documentation for global review with US and international manufacturing facilities.

Skills and Requirements:

  • S. degree in science, business or technical related field to perform all aspects of the job.
  • The Quality Assurance Project Specialist is responsible for producing the highest quality results while operating within the constraints of the business timelines and guidelines.
  • Responsibilities also include developing positive relations with other individuals within as well as outside the department.
  • Must be able to deal effectively with problems and customers.
  • Must have knowledge of applicable regulatory standards and requirements for infant formula and nutritional products.
  • Must have Advanced knowledge of Microsoft Office Suite, Adobe Acrobat, Visio, Access, and Lotus.

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-536-3075.

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.