Position Overview: We are seeking a detail-oriented Document Control Associate to support the Quality Assurance (QA) Specialist at our Nicholasville, KY manufacturing facility. The successful candidate will be responsible for providing both technical and administrative support to functional departments and their clients. This role requires a comprehensive understanding of document management processes, strong organizational skills, and the ability to collaborate effectively across multiple departments to ensure compliance with Good Manufacturing Practices (GMP).
This is an onsite position. No remote or hybrid work is allowed.
Key Responsibilities:
Document Lifecycle Management:
Facilitate the life cycle of master documents, including but not limited to SOPs, Batch Records, Test Methods, Protocols, Reports, and Specifications.
Function as a document workflow coordinator, ensuring documents are reviewed, edited, formatted, and maintained according to approved procedures and templates.
Monitor document properties, track document status, and manage approval notifications, distributions, and archiving processes.
Collaboration and Change Control:
Collaborate with cross-functional departments to ensure the timely implementation of document change requests.
Assist in managing change control processes associated with document updates and modifications.
Document Issuance and Support:
Issue and maintain effective documentation, including logbooks, procedures, test methods, specifications, batch documentation, and labels.
Maintain and manage issuance logs to ensure document control and traceability.
Execute duties associated with controlled document change requests, including formatting, approvals, effectiveness, and distribution.
Operational Support:
Provide day-to-day operational support for various departments, including scheduling, reporting, and records archiving.
Support the preparation and assist as needed during internal audits and/or regulatory inspections to ensure compliance with GMP and other regulatory requirements.
Required Qualifications:
Bachelor's degree in biology, Chemistry, or related field or equivalent experience in document control or quality assurance.
Proven experience in document control within a GMP-regulated environment.
Strong attention to detail and organizational skills.
Excellent communication and interpersonal skills.
Proficiency with electronic document management systems.
Preferred Qualifications:
Experience in a manufacturing or quality assurance environment, preferably within the pharmaceutical or biotechnology industries.
Familiarity with Good Documentation Practices (GDP) and other relevant regulations and guidelines.
Experience in supporting audits and regulatory inspections.