Data Integrity Officer

For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.

Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.

In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.

It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.

Your role at Simtra BioPharma Solutions:

The Data Integrity Officer provides oversight for site Data Integrity compliance and improvement initiatives; and is responsible for establishing and maintaining site KPI and metrics reporting processes. This position reports to the Manager II, Quality and sits on site in Bloomington, Indiana.

What you'll do:

• Leads a cross-functional team in the planning, developing, and conducting of assessments and remediation action plans for Data Integrity. Reports on facility's weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions. Evaluates corrective and preventive action responses to data integrity audit or assessment findings for adequacy, including root cause and timeliness.
• Identifies and closes gaps related to data integrity, validation, and corporate procedures. Supports routine GMP and Pre-Approval Inspection regulatory, client, and internal audits. Interfaces with regulatory inspectors during audits as required.
• Provide Quality input to risk remediation activities.
• Author, review, and/or approve documentation as required.
• Supports the development and monitoring of appropriate metrics for site quality systems, projects, and improvement initiatives. Reports data to management when required for internal metrics.
• Provides guidance and technical expertise in interpreting regulatory and Simtra requirements in quality strategy and processes.

What you'll bring

• Bachelor's degree required, in a scientific or technical discipline preferred.
• Minimum 5 years experience in the pharmaceutical/biotech industry.
• Thorough knowledge of worldwide regulatory agency regulations for Documentation and Data Integrity.
• Project Management skills preferred.
• Experience with computer system validation and data integrity principles preferred
• 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:

• Must be able to gown qualify for Grade C and D production areas
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position may require sitting or standing for long hours.

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Equal Employment Opportunity

Simtra is 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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Reasonable Accommodations

Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Data Privacy

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https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy