Quality Documentation Specialist – Pharma & Compliance

simtrabps; Bloomington (IN); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with公司匹

Paid Holidays

Paid Time Off

Paid Parental Leave

Job summary

The Documentation Specialist at Simtra BioPharma Solutions assists in preparing and maintaining Quality System documentation, including SOPs, forms, and logbooks. This role supports document change control and reports to a Quality Supervisor or Manager.

Requirements include a high school diploma (associates preferred), 2+ years in documentation/change control, and skills in Word, Excel, Outlook and enterprise software like JDE, BPLM, Pilgrim, TrackWise.

Qualifications

• High school diploma required.
• Associates degree preferred.
• Minimum 2 years experience with documentation and/or change control systems.
• Proficiency in MS Word, Excel, Outlook and enterprise software (examples include 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

Change control

Attention to detail

Education

High school diploma

Associates degree preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

JDE

BPLM

Pilgrim

TrackWise

Job description

The Documentation Specialist at Simtra BioPharma Solutions assists in preparing and maintaining Quality System documentation, including SOPs, forms, and logbooks. This role supports document change control and reports to a Quality Supervisor or Manager.

Requirements include a high school diploma (associates preferred), 2+ years in documentation/change control, and skills in Word, Excel, Outlook and enterprise software like JDE, BPLM, Pilgrim, TrackWise.