Compliance Data Specialist GMP Investigations

Rensselaer, NY - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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.

Qualifications :

Minimum Qualifications

Bachelors 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.

Preferred Qualifications

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.

Additional Information :

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.

#LI-EB1

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Employment Type :

Full-time

Lead the collection manipulation and analysis of compliance-related data to support GMP investigations and continuous improvement initiatives.Assist with internal auditsDevelop and maintain Power BI dashboards and visualizations to communicate compliance trends metrics and investigation outcomes to ...

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.

Qualifications :

Minimum Qualifications

Bachelors 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.

Preferred Qualifications

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.

Additional Information :

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.

#LI-EB1

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

Employment Type :

Full-time

Key Skills

GIS
Computer Data Entry
Facilities Management
ADMA
Fleet
Key Account

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About Company

Eurofins

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more

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