Quality Systems Specialist

hace 2 semanas


Manatí, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

**About Us**

Flexible & Integrated Technical Services, LLC is a leading provider of technical services to the Pharmaceutical, Medical Device and Manufacturing industries. We pride ourselves on our flexibility, family-oriented culture and focus on our resources' well-being.

**Job Title: Quality Systems Specialist**

We are seeking a highly skilled Quality Systems Specialist to join our team. In this role, you will be responsible for managing document control, record retention programs, compliance and custody of SOP's, and reviewing/approving/issuing master documentation related to operational areas and evaluating compliance of all procedures (SOP's) and master documentation with regulations and company policies.

**Responsibilities**
  • Manage document control, including record retention programs, compliance and custody of SOP's.
  • Review, approve and issue master documentation related to operational areas.
  • Evaluate compliance of all procedures (SOP's) and master documentation with regulations and company policies.
  • Provide guidance and support on the transfer and introduction of new products and processes to the site to maintain quality and compliance.

**Requirements**

To be successful in this role, you will need:

  • Bachelor's Degree in Chemical, Engineering, Biology or Microbiology Science.
  • Five years of experience in Pharmaceutical Manufacturing industry.
  • Bilingual (English & Spanish).
  • Experience in GMP, FDA, EU regulations.

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