Quality Documentation Specialist

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.

This role:

The Documentation Specialist is responsible for compiling all documentation required for batch manufacturing, including printing of controlled forms from Veeva for each Manufacturing batch produced in their building, generating additional controlled forms needed during the batch manufacturing process, as well as management of the process sign-out and sign-in of batch records from the Documentation Center. This role will also be responsible for assisting employees with correction resolution and handling the executed batch record documentation while going through the correction process. This role will also have secondary responsibilities assigned to help manage the work load in the Documentation Centers. These responsibilities could include, batch record review, support section review, non-batch related documentation review, controlled form reconciliation and audit trail review. He or she provides customer service to internal customers, as well as communicates effectively with all levels of the organization.

The hours for this role are Monday-Friday 3:30p-11:30p.

The responsibilities:

• Perform assigned tasks related to Veeva and ERP system for batches.

• Perform batch record review for GMP support sections produced at Simtra for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.

• Reconcile discrepancies with documentation and/or electronic systems as appropriate.

• Compile documentation packets for batch manufacturing, including printing of controlled forms and other serialized or controlled documentation that is not part of the effective manufacturing batch record.

• As needed during operations, generate additional batch documents for batches in progress. This may include supplemental batch record sections, controlled forms, and documents of other types.

• Manage the process of sign-out and sign-in of batch records.

• Manage the process of correction resolution, assisting personnel with controlled access to executed records requiring documentation corrections.

• Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.

• Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.

Qualification

• Associates degree or 2 years of similar relevant experience

• Experience with documentation and/or quality control systems preferred

• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, etc.)

Physical / Safety Requirements:

• Occasionally required to lift and/or move objects (boxes, totes, etc.) weighing 25 pounds

• Duties may require nights and weekend work

• Use of hands and fingers to manipulate office equipment is required

• Position requires sitting for long hours but may involve walking or standing for periods of time

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

• 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

• Additional Benefits

• 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 12/31/25

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.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy: https://simtra.com/privacy-policy/