Deviation Investigator
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Job Location:
Allendale County, SC - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
OVERVIEW
The Lead Deviation Investigator is responsible for overseeing conducting and documenting investigations related to deviations nonconformances and quality events. This role ensures timely thorough and compliant investigations that identify true root causes and drive effective corrective and preventive actions (CAPA). The role requires strong analytical skills technical writing expertise and the ability to collaborate across cross functional teams.
KEY RESPONSIBILITIES
Deviation & Nonconformance Investigations
Lead end to end investigations for deviations and quality events.
Gather and analyze data interview personnel and review documentation to understand event details.
Apply structured root cause analysis methodologies (e.g. Causal Factor 5 Whys Fishbone Fault Tree).
Ensure investigations are completed within required timelines and meet regulatory and internal quality standards.
Root Cause Analysis & CAPA
Identify true root causes supported by evidence.
Develop effective CAPA plans that address root causes and prevent recurrence.
Partner with process owners to ensure CAPA implementation effectiveness checks and closure.
Technical Writing & Documentation
Prepare clear concise and compliant investigation reports.
Ensure documentation meets GMP and regulatory expectations.
Cross Functional Collaboration
Maintain high standards of accuracy clarity and traceability.
Work closely with Operations Quality Assurance Engineering Maintenance and other departments.
Facilitate investigation meetings and lead cross functional problem solving sessions.
Required Knowledge & Skills
Strong understanding of GMP GDP and regulatory expectations.
Expertise in root cause analysis tools and structured problem solving.
Proficiency in CAPA development implementation and effectiveness evaluation.
Excellent technical writing and documentation skills.
Ability to interpret data trends and process performance indicators.
Strong communication facilitation and interpersonal skills.
Ability to manage multiple investigations simultaneously and prioritize effectively
PREFERRED QUALIFICATIONS
Experience in pharmaceutical biotech medical device or other regulated manufacturing environments.
Familiarity with electronic quality systems (TrackWise Veeva etc.).
Background in engineering life sciences or a related technical field. Experience leading Deviation Investigations
**Weil Group is proud to be an Equal Employment Opportunity Employer**
The Lead Deviation Investigator is responsible for overseeing conducting and documenting investigations related to deviations nonconformances and quality events. This role ensures timely thorough and compliant investigations that identify true root causes and drive effective corrective and preventive actions (CAPA). The role requires strong analytical skills technical writing expertise and the ability to collaborate across cross functional teams.
KEY RESPONSIBILITIES
Deviation & Nonconformance Investigations
Lead end to end investigations for deviations and quality events.
Gather and analyze data interview personnel and review documentation to understand event details.
Apply structured root cause analysis methodologies (e.g. Causal Factor 5 Whys Fishbone Fault Tree).
Ensure investigations are completed within required timelines and meet regulatory and internal quality standards.
Root Cause Analysis & CAPA
Identify true root causes supported by evidence.
Develop effective CAPA plans that address root causes and prevent recurrence.
Partner with process owners to ensure CAPA implementation effectiveness checks and closure.
Technical Writing & Documentation
Prepare clear concise and compliant investigation reports.
Ensure documentation meets GMP and regulatory expectations.
Cross Functional Collaboration
Maintain high standards of accuracy clarity and traceability.
Work closely with Operations Quality Assurance Engineering Maintenance and other departments.
Facilitate investigation meetings and lead cross functional problem solving sessions.
Required Knowledge & Skills
Strong understanding of GMP GDP and regulatory expectations.
Expertise in root cause analysis tools and structured problem solving.
Proficiency in CAPA development implementation and effectiveness evaluation.
Excellent technical writing and documentation skills.
Ability to interpret data trends and process performance indicators.
Strong communication facilitation and interpersonal skills.
Ability to manage multiple investigations simultaneously and prioritize effectively
PREFERRED QUALIFICATIONS
Experience in pharmaceutical biotech medical device or other regulated manufacturing environments.
Familiarity with electronic quality systems (TrackWise Veeva etc.).
Background in engineering life sciences or a related technical field. Experience leading Deviation Investigations
**Weil Group is proud to be an Equal Employment Opportunity Employer**
Key Skills
- Epidemiology
- Public Health
- Bank Secrecy Act
- Bioinformatics
- Fraud
- Genetics
- Interviewing
- Law Enforcement
- Qualitative Research Interviewing
- Research Experience
- Next Generation Sequencing
- Writing Skills
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