Quality Documentation Specialist

Simtra BioPharma Solutions • Bloomington, IN

60d

About The Position

The Documentation Specialist assists in preparing and/or maintaining Quality System documentation including standard operating procedures (SOPs), forms and logbooks. This role also assists the site's Subject Matter Experts in the execution of document change control. This position reports to a Quality Supervisor or Manager.

Requirements

• High school diploma required.
• Minimum 2 years experience with documentation and/or change control systems required.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Documentum, Veeva etc.) required.

Nice To Haves

• Associates degree preferred.

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.

Benefits

• Day One Benefits
• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
• Spouse Life Insurance
• Child Life Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
• Paid Holidays
• Paid Time Off
• Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Employee Ownership Plan
• Voluntary Insurance Benefits
• Vision Coverage
• Accident
• Critical Illness
• Hospital Indemnity Insurance
• Identity Theft Protection
• Legal and more
• Workout Facility
• Cafeteria
• Credit Union

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees