What are the responsibilities and job description for the Compliance Data Specialist - GMP Investigations position at Katalyst CRO?
Job Description
**Minimum Qualifications**
**Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.**
- Lead the **collection, manipulation, and analysis of compliance-related data** to support GMP investigations and continuous improvement initiatives.
- Assist with **internal audits**
- Develop and maintain **Power BI dashboards and visualizations** to communicate compliance trends, metrics, and investigation outcomes to stakeholders.
- Collaborate with cross-functional teams to identify **root causes of non-conformances** and recommend corrective and preventive actions (CAPAs).
- Support the preparation of **investigation reports** for medium to high-severity events, ensuring clarity, accuracy, and alignment with regulatory expectations.
- Monitor production and quality systems to gather data that informs investigation findings and compliance trends.
- Assist in the review and revision of controlled documents (e.g., SOPs, batch records, logbooks) to ensure alignment with cGMP standards.
- Participate in cross-functional meetings to present findings and drive resolution of compliance issues.
- Contribute to the development of **quality metrics** and KPIs that align with site and client goals.
**Minimum Qualifications**
- Bachelor’s degree in Life Sciences, Chemistry, Biology, or a related technical field.
- Authorization to work in the US indefinitely, unrestricted and without sponsorship.
- 2 years of experience with **data analysis tools** , particularly **Power BI** , Excel, and other visualization platforms.
- Excellent written and verbal communication skills, with the ability to present complex data clearly.
- Detail-oriented, self-motivated, and able to work independently in a client-facing environment.
- Familiarity with **GMP investigations** and regulatory compliance.
- Experience supporting **QA/Compliance functions** in a pharmaceutical setting.
- Experience with systems, such as **LIMS** , **QMS** , or **Veeva**
- Experience with coding languages, such as **SQL** , **Python,** **R** , **VBA**
- Prior involvement in **investigation authoring or review**.
- Understanding of biologics manufacturing operations and quality systems.
- Candidates located within a commutable distance of **Rensselaer, NY** are encouraged to apply.
- Position is full-time, Monday-Friday, 8:00am-5:00pm. ****
- Base compensation is **$21.50 - $26.25** **per hour** based on degree and relevant experience.
**Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.**
Salary : $22 - $26
