A leading logistics company based in Indianapolis is seeking a Document Control and Regulatory Specialist to manage compliance across pharmaceutical operations. This role requires experience in regulatory requirements, document management, and collaboration with cross-functional teams. Ideal candidates will have a Bachelor's degree in a relevant field and 3-5 years in document control or regulatory compliance. The position demands strong organizational skills and knowledge of cGMP and related regulations. Physical demands include occasional lifting and working in a warehouse environment, while the position is primarily office-based.
Qualifications
3-5 years of experience in document control or regulatory compliance.
Strong knowledge of FDA, ICH, and other regulatory requirements.
Proven ability to apply regulatory requirements to logistics operations.
Responsibilities
Manage the document control system and ensure compliance.
Support internal and client audits, providing necessary documentation.
Collaborate with cross-functional teams to maintain operational documents.
Skills
Knowledge of cGMP
Strong organizational skills
Regulatory compliance
MS Office proficiency
Problem-solving skills
Education
Bachelor's degree in Life Sciences or related field
Tools
Document management systems
QMS software
Job description
A leading logistics company based in Indianapolis is seeking a Document Control and Regulatory Specialist to manage compliance across pharmaceutical operations. This role requires experience in regulatory requirements, document management, and collaboration with cross-functional teams. Ideal candidates will have a Bachelor's degree in a relevant field and 3-5 years in document control or regulatory compliance. The position demands strong organizational skills and knowledge of cGMP and related regulations. Physical demands include occasional lifting and working in a warehouse environment, while the position is primarily office-based.