Proclinical is currently recruiting for a Quality Investigator with a biotechnology company located in Durham, NC.
- Leads investigations for Quality deviations and incidents.
- Conducts Quality investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing safety regulations.
- May support complex and/or high impact investigations.
- Identifies root and contributing causes and makes recommendations to correct and/or prevent recurrence.
- Documents investigation reports and findings in designated Quality systems. Ensures required management and Quality approvals on final investigations while satisfying established due dates.
- Facilitates corrective and preventive action agreement with stakeholders.
- Facilitates internal sharing of investigational findings and risk knowledge.
- Contributes to metrics related to investigation process and CAPA effectiveness.
- Participates in site deviation/CAPA management forums related to investigation status updates, metrics and escalation items
- Presents investigations during internal and external audits.
Skills and Requirements:
- S. degree in Engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline.
- A minimum of 5 years of experience in a lab and operations environment (industrial/plant experience preferred)
If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 267-297-3257.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.