About The Position

The QA Compliance Intern will provide foundational administrative and operational support to the Quality Department. This role is designed to offer a student or recent graduate hands-on experience in oversight of external manufacturing operations and Contract Manufacturing Organization (CMO) partnerships. As an intern, you will assist in ensuring compliance with international regulatory requirements and industry standards and support the internal quality team with various tasks and projects.

Requirements

  • Currently enrolled in or a recent graduate of a BA/BS program in Life Sciences, Chemistry, Pharmacy, or a related field.
  • Excellent verbal and written communication skills with a focus on professional email etiquette.
  • Proficiency in Microsoft Office Suite (Word, Excel, Outlook) is required.
  • High attention to detail and the ability to manage multiple assignments simultaneously while meeting deadlines.
  • Ability to ask compelling questions and a desire to understand
  • Ability to work both autonomously and collaboratively in a fast-paced environment.
  • Basic knowledge of CAPAs, Deviation investigations, Change Controls, and Supplier Qualification Program.

Nice To Haves

  • Previous internship or coursework related to Quality Assurance, Quality Control, or Regulatory Compliance is a plus but not required.

Responsibilities

  • Assist in the initiation and administrative tracking of incoming inquiries, including Product Quality Complaints (PQCs), Adverse Events (AEs), and Medical Inquiries (MIs).
  • Support the Quality Team in maintaining seamless communication between internal departments (Supply Chain, Pharmacovigilance, Regulatory Affairs) and external manufacturing partners.
  • Learn to support the initiation of investigations, CAPAs (Corrective and Preventive Actions), change controls, and validation documentation within a Good Manufacturing Practice (GMP) environment.
  • Monitor the general QA mailbox, ensuring inquiries are routed to the appropriate stakeholders in a timely manner.
  • Assist in the maintenance and implementation of internal policies, procedures, and training programs.
  • Contribute to the organization of files and documentation required for internal and external audits.
  • Provide general project management support for the Quality Department, including data entry into Excel and drafting correspondence.
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