Documentation 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 (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams - so we can solve problems in new ways.

Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

The role:

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.

The 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.

Required 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 (examples include: JDE, BPLM, Pilgrim, TrackWise, etc.)

Physical / Safety Requirements:

• Occasionally required to lift and/or move objects (boxes, files, etc.) weighing 25 pounds.
• Duties may require overtime work, including nights and weekends.
• Position requires sitting for long hours, but may involve walking or standing for periods of time.
• Use of hands and fingers to manipulate office equipment is required.

In return, you’ll be eligible for [1] :

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life 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
• Additional Benefits
  • Short and Long-Term Disability Insurance
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

[1] Current benefit offerings are in effect through 12/31/26

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.