Documentation Systems Coord

Location: Plainfield, Indiana
Posted On: 3/13/2017
Job Code: Documentation System
Job Description
Ensure a safe and quality working environment through training, awareness and compliance to safety guidelines and SOPs. Ensure the maintenance of their department, premises and equipment.

1. Process various site documentation using the PC system including: SOPs, procedures, parts, schematics and drawings.
2. Catalog, scan, maintain, file and retrieve various site documents including SOPs, Deviations, ECOs, Regulatory Documents and validation protocols.
3. Review and process ECOs and Deviations.
4. Update the training database (Compliance wire) as needed in the course of processing ECOs.
5. File and maintain files for training documentation, production documentation and records produced by the facility in the normal course of business.
6. Update and make corrections to the Inventory management database (BPCS), as needed in the course of processing ECOs and in the normal course of business.
7. Updating various information containing indexes (EXCEL/Access) as necessary.
8. Support the site during audits and inspections.
9. Ensure daily tasks are completed in a timely manner with strict attention to detail and in accordance to applicable SOPs and GMPs.

1. Other duties as assigned with or without accommodation.
2. All employees are expected to pay attention to and work in support of a safe and healthy work environment. This includes following the established rules, policies and practices of environmental, health and safety with specific attention to the Rules.


Education required/ preferred: Associate degree in science or technical field preferred.

Experience: Minimum 3 years documentation experience in a GMP facility or in the medical transcription field. Office administration experience will also be considered.
Preferred Skills/Qualifications: Experience with AS400 Systems (BPCS), Agile and Compliance Wire is preferred. Experience with creating and maintaining procedures and work instructions. Ability to understand and follow directions and ask for clarifications if necessary. Ability to comply with FDAs Code of Federal Regulations (CFR), and ISO13485 standards. Demonstrated ability to closely adhere to all instructions, GMPs, SOPs, policies and procedures required.
Skills/Competencies: Excellent verbal and written communication skills. Strong grammatical and document layout, design, formatting skills are mandatory. Ability to accurately type 45 words per minute.
Other Skills: Computer proficiency with Word, Excel, Access, Visio, Power Point and Outlook is desirable.

This position reports to the Supervisor, Plant Quality.

Normal office conditions with routine visits throughout the warehouse, receiving and shipping areas. These areas include hazards for temperature fluctuation and light machinery such as forklift traffic. While performing the duties of this job, the employee is regularly required to sit, talk, hear and use hands and arms to reach. The employee is occasionally required to stand, walk, lift and use hands or fingers to handle office equipment, controls or to feel objects. Specific vision abilities required by this job include close vision and ability to adjust focus. The noise level in the office environment is low to moderate; in the warehouse areas, noise level may be moderate to high for short periods.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Category:IT  code:new
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Contact Details
Sagar Rathore
E-mail Address