Document Control and Regulatory Specialist

Document Control and Regulatory Specialist Indianapolis, IN Job Details Full-time 1 day ago Benefits Health insurance Dental insurance 401(k) Vision insurance Life insurance Qualifications Regulatory inspections Record keeping Computer operation Document review (document control) Procedural guides Computer literacy Digital archiving Compliance audits & assessments Logistics Corrective and preventive actions (CAPA) GMP Research Mid-level 3PL 3 years Compliance management implementation Regulatory legal research ICH guidelines Bachelor's degree Continuous improvement Pharmacy Productivity software Quality systems Training Cross-functional collaboration Document management systems Communication skills Cross-functional communication Internal audits FDA regulations Full Job Description The Document Control and Regulatory Specialist contributes to Langham Logistics' goals of exceptional customer service, quality, process improvement, and profitability by managing the document control system and supporting regulatory compliance activities across the organization. This role ensures regulatory, quality, and operational documents are properly created, reviewed, approved, maintained, distributed, and archived in accordance with applicable requirements. This position supports compliance across pharmaceutical logistics operations, including temperature-sensitive biologics, raw materials, vaccines and general pharmaceutical products, helping maintain audit readiness and alignment with cGMP, GDP, FDA, ICH and client requirements. Key Outcomes Expected Manage the creation, revision, review, approval, issuance, distribution, and archival of controlled documents, including SOPs, work instructions, policies, forms, and quality agreements. Maintain the document control system to ensure documents are current, properly versioned, retrievable, and accessible to authorized personnel. Monitor document review cycles, periodic reviews, and expiration timelines to ensure timely updates and continued compliance. Support implementation and maintenance of Quality Management System (QMS) procedures related to document control and regulatory compliance. Ensure compliance with applicable federal, state, international, and client-specific requirements, including cGMP, GDP, FDA, ICH, and other relevant pharmaceutical logistics regulations. Conduct regulatory research and monitor changes in regulations, guidance, or industry practices that may affect storage, handling, distribution, documentation, or quality systems. Collaborate with quality, operations, warehouse, and cross-functional teams to develop, revise, format, and maintain documents and processes that support compliant operations. Support internal audits, client audits, and regulatory inspections by providing complete, accurate, and readily retrievable documentation and by assisting with CAPA follow-up activities as needed. Evaluate and support approval of regulatory and quality documentation related to new products, shipping procedures, vendor compliance, and operational changes. Maintain records, logs, reporting, and metrics to support audit readiness, management review, and continuous improvement initiatives. Provide guidance and training to associates on document control procedures, regulatory requirements, and compliance practices. Maintain proper retention, archival, and retrieval practices for historical, quality, and regulatory records and support continuous improvement of document control and compliance programs. Education and Experience Bachelor's degree in Life Sciences, Quality Management, Regulatory Affairs, Pharmacy, or a related field preferred. 3-5 years of experience in document control, quality systems, and/or regulatory compliance within pharmaceutical, biotech, or 3PL logistics environments. Strong knowledge of cGMP, GDP, FDA, ICH, and related pharmaceutical or logistics regulatory requirements. Experience with document management systems and/or QMS software. Proven ability to interpret and apply regulatory and quality requirements to warehouse, storage, and distribution operations. Strong organizational, communication, and problem-solving skills. Proficiency with MS Office applications.

Preferred Skills:

Experience with cold chain logistics for biologics and vaccines. Familiarity with ISO standards such as ISO 9001 and ISO 13485, and other applicable quality frameworks. Experience supporting internal audits, client audits, regulatory inspections, and client regulatory requests or submissions. Familiarity with temperature-sensitive product handling, validation protocols, risk management, and vendor compliance processes.

Physical Demands and Work Environment:

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). This role operates in a regulated warehouse and office environment, including areas handling temperature-sensitive biologics, vaccines, raw materials, and other pharmaceutical products. The position is primarily office-based but requires regular interaction with operational teams to support compliant storage, handling, and distribution practices. Occasional travel may be required for audits, training, inspections, or client meetings. Must be able to operate computer equipment.

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. Applicant Tracking Software by

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