SUMMARY

The Documentation Specialist is responsible for the creation and maintenance of documents for Quality and Operations. This person will also be responsible for the primary administrative functions for Quality and assists the Director of Quality as assigned. Responsible for upholding the documented Standard Operating Procedures that are designed to support the development, implementation, and control of the ISO 22716:2007 standard.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Organizes documents and communicates their location so they can be used by R&D, Production, Marketing and other support departments as needed.
Responsible for reviewing standard operating procedures to insure procedures are being practiced.
Interface with R&D, Quality, Marketing, etc. staff to stay up to date on project status and business priorities.
Responsible for maintaining and updating Quality Department’s procedural manual
Maintain documentation of all pertinent information and communicate with co-workers as needed to help them utilize documentation.
Maintains a high level of focus and attention to detail at all times.
Prepares reports and technical papers, as assigned.
Works with confidential material on a daily basis and is required to maintain confidentiality at all times.
Assists Director of Quality with project and documentation completion and verification.
Assists Director of Quality with entering documents into and maintaining document control system (including SOPs, CAPA program, change control documents, Quality KPI, etc.)
This position is responsible for following all documented cGMP (current Good Manufacturing Practices), SOP’s (Standard Operating Procedures), Work Instructions, and Policies designed to support the development, implementation, and control of the ISO 22716:2007 standard.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND/OR EXPERIENCE

Bachelor’s degree (B.S) in Science or Business Administration preferred; plus, three to five years’ related experience and/or training; or equivalent combination of education and experience.
Quality Assurance, GMP and other Compliance or Regulatory type experiences are a plus. Must have the ability to create, maintain and read computer generated files such as formulas, procedures, specifications, and ingredient label format. The ability to generate reports from electronic data is also required in this position. Proficient in Microsoft works: Word, Excel, Outlook.
Familiarity/Experience managing Quality Document Control Systems.
Job Type: Full-time
Pay: $40,000.00 - $60,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Ability to Commute:

• Indianapolis, IN 46278 (Required)

Ability to Relocate:

• Indianapolis, IN 46278: Relocate before starting work (Required)

Work Location: In perso

This job does not have supervisory responsibilities.