Deviation Investigator

Flexible & Integrated Technical Services

Job Location:

Allendale County, SC - USA

Monthly Salary: Not Disclosed

Posted on: 3 days ago

Vacancies: 1 Vacancy

Job Summary

ForQualityservices in the PR01 Plant

WHAT MAKES YOU A FIT:

The Technical Part:

Bachelors degree in Engineering or Life Scienceswith five (5) years of experience in leading Deviation Investigations within the pharmaceutical biotech medical device or other regulated manufacturing environment.
Experience in:
- Conductingand documenting investigations related to deviations nonconformances and quality events.
- Electronic quality systems (Trackwise Veeva etc.)
- Root cause analysis tools and structured problem solving.

The Personality Part:

If you consider yourself an ingenious and creative problem-solver with an uncanny ability to lead then this is the job for you! Sprinkle on a love for the scientific method teamwork and above all else being ethical and you just might have what it takes to take on this new challenge. Bring it on!

AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)

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.
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.
Prepare clear concise and compliant investigation reports.
Ensure documentation meets GMP and regulatory expectations.
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.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys puzzle: you! We integrate Engineering Construction Maintenance Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible family-oriented and focused on our resources well-being while providing our Pharmaceutical Medical Device and Manufacturing industryclients with top-notch quality talent.Were FITS!

Are you the next piece

Required Experience:

Senior IC

ForQualityservices in the PR01 PlantWHAT MAKES YOU A FIT:The Technical Part:Bachelors degree in Engineering or Life Scienceswith five (5) years of experience in leading Deviation Investigations within the pharmaceutical biotech medical device or other regulated manufacturing environment.Experience ...

ForQualityservices in the PR01 Plant

WHAT MAKES YOU A FIT:

The Technical Part:

Bachelors degree in Engineering or Life Scienceswith five (5) years of experience in leading Deviation Investigations within the pharmaceutical biotech medical device or other regulated manufacturing environment.
Experience in:
- Conductingand documenting investigations related to deviations nonconformances and quality events.
- Electronic quality systems (Trackwise Veeva etc.)
- Root cause analysis tools and structured problem solving.

The Personality Part:

If you consider yourself an ingenious and creative problem-solver with an uncanny ability to lead then this is the job for you! Sprinkle on a love for the scientific method teamwork and above all else being ethical and you just might have what it takes to take on this new challenge. Bring it on!

AS A PIECE OF FITS YOU WILL: (The day-to-day on the job)

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.
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.
Prepare clear concise and compliant investigation reports.
Ensure documentation meets GMP and regulatory expectations.
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.