Documentation Specialist

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 (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.

Why join Team Simtra?

Because we:

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.
• Associates degree preferred.
• 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] :

• Day One Benefits
  • 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.

Equal Employment Opportunity

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.

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