GMP Quality Doc & Change Control Specialist

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

401(k) with Company Match

Paid Holidays

Paid Time Off

Paid Parental Leave and more

Job summary

Simtra BioPharma Solutions seeks a Documentation Specialist to assist in preparing and maintaining Quality System documentation such as SOPs, forms and logbooks. This role supports subject matter experts in document change control and reports to a Quality Supervisor or Manager.

The role requires at least a high school diploma and 2 years' experience with documentation or change control, plus proficiency in Word, Excel, Outlook and related enterprise software.

Qualifications

• High school diploma required.
• Minimum 2 years experience with documentation and/or change control systems.
• Proficient in Word, Excel, Outlook and enterprise software such as JDE, BPLM, Pilgrim, TrackWise.

Responsibilities

• Reviews, process and releases Quality related documents using the EDMS system. The review ensures documents and change management are compliant with site procedures.
• Coordinates Periodic Review process.
• Maintains and modifies related department procedures as needed.
• Generates and maintains performance reports and related metrics.

Education

High school diploma

Tools

Microsoft Word

Excel

Outlook

JDE

BPLM

Pilgrim

TrackWise

Job description

Simtra BioPharma Solutions seeks a Documentation Specialist to assist in preparing and maintaining Quality System documentation such as SOPs, forms and logbooks. This role supports subject matter experts in document change control and reports to a Quality Supervisor or Manager.

The role requires at least a high school diploma and 2 years' experience with documentation or change control, plus proficiency in Word, Excel, Outlook and related enterprise software.