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Quality Assurance Specialist

Salary undisclosed

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Position Overview:

We are seeking a highly organized and detail-oriented Quality Assurance Specialist to join our team at the Nicholasville, KY manufacturing facility. The successful candidate will be responsible for supporting the quality assurance processes, ensuring that all quality-related documentation, procedures, and standards are properly implemented and maintained in accordance with Good Manufacturing Practices (GMP) and ISO 13485:2016. This role requires strong communication skills, a comprehensive understanding of QA processes, and the ability to collaborate across departments to ensure compliance with all relevant regulations.

This is an onsite position. No remote or hybrid work allowed.

Key Responsibilities:

Document Control and Compliance:

  • Oversee the entire document lifecycle for quality-related documents, including SOPs, Batch Records, Test Methods, Protocols, Reports, and Specifications.
  • Ensure that all quality documentation follows approved procedures, maintaining high standards for formatting, reviewing, editing, and archiving.
  • Manage the approval process for quality documents, coordinating with relevant departments and ensuring compliance with GMP and other regulatory guidelines.

Change Control and Collaboration:

  • Lead the implementation of document and procedural changes, managing the change control process effectively.
  • Work cross-functionally to ensure timely updates and modifications of QA documentation.
  • Serve as a key point of contact for document issuance and control, ensuring traceability and accuracy of logbooks, procedures, and batch documentation.

Quality Assurance Operations:

  • Support various departments in day-to-day quality-related tasks, including scheduling, reporting, and records archiving.
  • Assist in preparing for and participating in internal audits and regulatory inspections, ensuring that the company meets GMP, GDP, and ISO 13485:2016 and other relevant regulatory standards.
  • Act as a key member of the quality team, supporting efforts to continuously improve QA processes.

Required Qualifications:

  • Bachelor’s degree in Biology, Chemistry, or a related field, or equivalent experience in quality assurance.
  • Proven experience in a quality assurance role within a GMP-regulated environment.
  • Strong attention to detail and excellent organizational skills.
  • Proficiency with electronic document management systems (EDMS).
  • Excellent communication and interpersonal skills.

Preferred Qualifications:

  • Experience in quality assurance within the pharmaceutical or biotechnology industries.
  • Familiarity with Good Documentation Practices (GDP) and other relevant industry regulations.
  • Experience in supporting audits and regulatory inspections.