Documentation Specialist — Quality Systems & Change Control

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 48,000 - 72,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Company Match

Paid Time Off & Holidays

Education Assistance

Job summary

Simtra BioPharma Solutions is seeking a Documentation Specialist in Bloomington, IN to assist in preparing and maintaining Quality System documentation, SOPs, forms, and logbooks. You will support change control activities and collaborate with Subject Matter Experts under a Quality Supervisor or Manager.

The role requires a high school diploma, 2+ years in documentation/change control, and proficiency with Word/Excel/Outlook and enterprise software such as JDE, BPLM, Pilgrim, TrackWise.

Qualifications

• High school diploma required.
• Minimum 2 years experience with documentation and/or change control systems.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software.

Responsibilities

• Reviews, process and releases Quality related documents using the EDMS system.
• Coordinates Periodic Review process.
• Maintains and modifies related department procedures as needed.
• Generates and maintains performance reports and related metrics.

Skills

Documentation systems

Change control

MS Word

MS Excel

MS Outlook

Education

High school diploma

Tools

JDE

BPLM

Pilgrim

TrackWise

Job description

Simtra BioPharma Solutions is seeking a Documentation Specialist in Bloomington, IN to assist in preparing and maintaining Quality System documentation, SOPs, forms, and logbooks. You will support change control activities and collaborate with Subject Matter Experts under a Quality Supervisor or Manager.

The role requires a high school diploma, 2+ years in documentation/change control, and proficiency with Word/Excel/Outlook and enterprise software such as JDE, BPLM, Pilgrim, TrackWise.