Compliance Data Specialist GMP Investigations
Compliance Data Specialist GMP Investigations
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Salary Not Disclosed
1 Vacancy
Job Description
- 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.
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Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
