Quality Assurance and Regulatory Specialist

1 week ago


Reston, Virginia, United States Applechem - A Solabia Group Company Full time

Key Responsibilities:

As a Quality Assurance and Regulatory Specialist at Applechem, you will be responsible for managing customer inquiries and complaint resolution processes related to product quality. You will also oversee the Corrective and Preventive Action (CAPA) program under the direction of the Quality Assurance Manager.

Key Responsibilities (continued):

You will provide oversight of Non-conformance, Internal Deviations, and equipment calibration and maintenance programs. Additionally, you will review internal production batch records for release and monitor incoming raw materials and finished goods release process with Quality Control.

Key Responsibilities (continued):

You will manage and monitor vendor, supplier, and OEM onboarding assessments to ensure that requisite quality documentation and quality management systems are in compliance with Applechem quality standards. You will also facilitate document control by creating and revising SOP's for quality processes for R&D, Production, Order Fulfillment, and other business units involved in API Manufacturing operations.

Requirements:

  • A Bachelor's Degree is required, with a strong preference for candidates holding degrees in scientific fields.
  • 3-5 years of experience in Quality Assurance and/or Regulatory roles within regulated industries.
  • Knowledge and understanding of ICH Q7 cGMP and ISO 9001:2015 Quality Management Systems Standards.
  • Working knowledge of relevant federal and state regulatory statues, including CFR 21 FD&C Act and OSHA Hazardous Communications Standard.
  • Basic understanding of EU REACH regulatory framework is preferred.
  • Advanced skills in MS Office applications, particularly Word and Excel.
  • Excellent attention to detail with strong communication skills.
  • Excellent proficiency in English, with proven ability to proofread and edit technical documents.

About the Role:

This role is responsible for ensuring that Applechem's quality management systems are in compliance with regulatory requirements. The successful candidate will have a strong understanding of quality management systems and regulatory requirements, as well as excellent communication and analytical skills.

About Applechem:

Applechem is a leading manufacturer of APIs and pharmaceutical products. We are committed to providing high-quality products and services to our customers, and we are seeking a talented and experienced Quality Assurance and Regulatory Specialist to join our team.



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