Document Control Specialist

Location: Indianapolis

Summary

The Document Control Specialist is responsible for the tactical oversight and maintenance of document control system for a new Radiopharmaceutical facility in Indianapolis, IN. The Document Control Specialist will be a primary contact point for document control support. This position will utilize quality assurance knowledge in maintaining the quality program to be ready for clinical development and GMP commercial operations. Additional responsibilities may include providing support for corporate activities.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Manage the process for the creation, review, approval, and issuance of GxP controlled site documents and records including batch records, logbooks, forms, procedures, protocols, templates, and reports.

• Manage electronic document management system (EDMS) document lifecycle workflows and assignment of reviewers / approvers and training tasks.

• Review the format and metadata of new documents to ensure compliance with approved templates, procedures and EDMS requirements.

• Provide guidance to document initiators, owners, and users to ensure compliance with all applicable procedures / regulations and assist users with EDMS workflow related issues.

• Manage the periodic review of controlled documents and partner with document owners to ensure periodic reviews are completed within the required timelines.

• Coordinate and liaise with other departments to facilitate uniform quality standards for the site.

• Ensure that compliance to the training program is maintained and updated as needed.

• Process DCR packages and review for correctness and completeness; monitor and update in-process documents.

• Create, assign, and archive QA controlled lab notebooks and logbooks.

Education and Experience

• Specialist: BS/MS in a Science related discipline preferred

• 3-5 years of quality assurance experience

• Pharmaceutical and GMP experience preferred.

• Experience working with FDA or other federal and state regulatory bodies.

Skills and Qualification

• Highly motivated and organized professional with the ability to work independently.

• Working knowledge of 21 CFR Parts 11, 210, and 211

• Very personable with strong communication skills

• Excellent professional ethics, integrity, and ability to maintain confidential information.

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision.

This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.

Work Environment

The noise level in the work environment is usually moderate.

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