Quality Documentation Specialist – EDMS & Change Control

Simtra US LLC; Bloomington (IN); On-site; USD 58,000 - 78,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Match

Time Off Program

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Short/Long-Term Disability

Vision Coverage

Cafeteria Access

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Documentation Specialist to support quality system documentation, SOPs, forms and logbooks at the site. The role collaborates with Subject Matter Experts on document change control and reports to a Quality Supervisor or Manager.

Responsibilities include reviewing and releasing quality documents in the EDMS, coordinating periodic reviews, maintaining procedures, and generating performance metrics required for FDA and internal audits.

Qualifications

• High school diploma required.
• Associates degree preferred.
• Minimum 2 years experience with documentation and/or change control systems.
• Proficiency in Microsoft Word, Excel, and Outlook; experience with enterprise software (e.g., JDE, BPLM, Pilgrim, TrackWise).

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 management

Change control

EDMS usage

MS Word / Excel / Outlook

Education

High school diploma

Associate degree preferred

Tools

JDE

BPLM

Pilgrim

TrackWise

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks a Documentation Specialist to support quality system documentation, SOPs, forms and logbooks at the site. The role collaborates with Subject Matter Experts on document change control and reports to a Quality Supervisor or Manager.

Responsibilities include reviewing and releasing quality documents in the EDMS, coordinating periodic reviews, maintaining procedures, and generating performance metrics required for FDA and internal audits.