Document Control Specialist
2 weeks ago
The Document Control Specialist contributes to meeting Langham goals of exceptional customer service, quality, process improvement, and profitability by managing and maintaining the document management system for Langham Logistics. This role ensures that all regulatory, quality, and operational documents are properly created, reviewed, approved, updated, and archived in compliance with cGMP, GDP, FDA, and client requirements. The Document Control Specialist plays a critical role in supporting regulatory compliance, audit readiness, and continuous improvement initiatives. Key Outcomes Expected Manage the creation, revision, approval, and distribution of SOPs, work instructions, policies, quality agreements, and other controlled documents. Maintain the document control system ensuring all documents are current, properly versioned, and accessible to authorized personnel. Ensure compliance with cGMP, GDP, FDA, ICH, and client-specific requirements for document management. Support internal audits, client audits, and regulatory inspections by providing accurate and complete documentation. Monitor document expiration and review cycles; facilitate timely updates and approvals. Assist quality and operations teams in drafting, formatting, and reviewing new or revised documents. Track and report on document control metrics to support management review and continuous improvement. Train associates on document control procedures and ensure compliance with established standards. Maintain proper archiving and retrieval procedures for historical and regulatory documentation. Education and Experience Bachelors degree in Life Sciences, Quality Management, Regulatory Affairs, or a related field preferred. 25 years of experience in document control or quality systems within pharmaceutical, biotech, or 3PL logistics environments. Solid knowledge of cGMP, GDP, FDA, and ICH document requirements. Experience with document management software (electronic or paper-based systems). Preferred Skills: Experience in cold chain logistics for biologics and vaccines. Familiarity with ISO standards (e.g., ISO 9001, ISO 13485) and regulatory inspections. Prior experience supporting audits and regulatory submissions. Knowledge of quality management systems (QMS) and compliance processes. Physical Demands Physical movements including bending, stooping, and lifting up to 75 pounds as part of daily work routine. May be working on concrete in a warehouse environment (subject to heat and cold). Must be able to operate computer equipment. Work Environment This role operates in a regulated warehouse and office environment, including areas handling temperature-sensitive biologics and vaccines. Some interaction with operational teams may be required, but this is primarily an office-based role. Occasional travel may be required for audits or client meetings. Disclaimer This job description is not intended to be all-inclusive. This position may be required to perform other related duties assigned to meet the ongoing needs of the organization. Langham reserves the right to modify job responsibilities and expectations as business demands evolve. #J-18808-Ljbffr
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Document Control Specialist
2 weeks ago
Indianapolis, United States Langham Logistics Full timeThe Document Control Specialist contributes to meeting Langham goals of exceptional customer service, quality, process improvement, and profitability by managing and maintaining the document management system for Langham Logistics. This role ensures that all regulatory, quality, and operational documents are properly created, reviewed, approved, updated, and...
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Indianapolis, United States Bristol-Myers Squibb Full timeDocument Control Specialist Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is...
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