The Document Control Specialist facilitates the flow of information throughout the organization and ensures the integrity, accuracy, and accessibility of quality documentation. This role regulates the control, distribution, retention, and archiving of cGMP documents while ensuring compliance with internal procedures and regulatory standards.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Write, revise, issue, and maintain QA documentation including SOPs, Work Instructions, Forms, Technical Files, Master Manufacturing Records (MMRs), Master Packaging Records (MPRs), Batch Records, Specifications, and other cGMP-related documents.
Coordinate and manage the change control process.
Oversee periodic review and updates of all company SOPs.
Identify process improvement opportunities related to efficiency and quality; implement updates through approved change control procedures.
Collaborate with subject matter experts to develop and improve SOPs.
Assist Quality Management with establishing, implementing, and maintaining the Quality Management System (QMS).
Review new and revised controlled documents for formatting, accuracy, consistency, and compliance.
Serve as document control software administrator, managing document numbers, content types, user access, and user groups.
Ensure compliance with company SOPs and policies.
Assist with improvements to document management systems.
Provide documentation (hard copy or electronic) for regulatory inspections and internal/external audits.
Generate and maintain document status reports.
Strong collaboration and interpersonal skills.
Effective verbal and written communication.
Excellent organizational and time management skills.
High attention to detail.
Initiative and learning orientation.
Ability to read, write, and speak English proficiently.
Experience navigating document control systems.
Strong computer skills, including Microsoft Office and ERP systems.
Knowledge of technical writing, process documentation, and document design.
Understanding of regulatory requirements and compliance standards.
Knowledge of basic office procedures and equipment.
Ability to follow and promote workplace safety practices.
Bachelor's degree required OR minimum of 3 years of experience in a Quality Management role.
Experience with Ensur (or similar document control software) preferred.
Ability to lift up to 15 lbs.
Ability to sit or stand for extended periods (4 hours).
Frequent use of keyboard, computer, and calculator.
Ability to bend, kneel, twist, reach (including overhead), and stoop as needed.
Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.
Document Control Specialist • Garland, TX, United States
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