TalentBurst
Title:
Sr. Quality Records Investigator
Location:
Houston, TX
Duration:
6-month+ with extension possibilities.
Schedule:
Monday thru Friday (8:00 AM-5:00 PM) Full Onsite.
Job Description The Deviation Investigator/Initiator is responsible for the initiation, investigation and completion of Minor and low/medium severity Major process deviations unassisted, and the supervised completion of high severity Major and Critical process deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to prevent recurrence.
Technical writing for the educated but uninformed reader, translate difficult and complex scientific events into a brief and cohesive report as a finished product. Accurately capture immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report.
Gathering data from various sources across the site, performing Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, assessing the event for impact to Safety Identity Strength Quality Purity (SISQP), performing trending analysis, identifying Corrective and Preventative Actions to reduce deviation recurrence, performing Risk Assessments, Causing Mapping, and interviewing.
Managing multiple projects and timelines concurrently. Ability to adhere to the standard timeline and elevate actions appropriately for timely resolution. Participation in the Daily Management meetings to update leadership or current deviation statuses.
Routine interaction with the customer, including compilation of Power Points to communicate investigational current status, alignment meetings, facilitated reviews, CAPA discussions, and comments resolution.
Working on the manufacturing floor for data gathering, observing processes for investigations, and conducting associate interviews.
Meeting facilitation and participation, aligning internal review team and area subject matter experts on an agreed investigational path forward. Complex conflict resolution, problem solving in a cross-functional setting, and ability to keep the meeting on track to achieve objectives of varying difficulty. Attendance and occasional leadership of the daily management system and participating/leading the deviation review board.
Perform other duties as assigned.
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Sr. Quality Records Investigator
Location:
Houston, TX
Duration:
6-month+ with extension possibilities.
Schedule:
Monday thru Friday (8:00 AM-5:00 PM) Full Onsite.
Job Description The Deviation Investigator/Initiator is responsible for the initiation, investigation and completion of Minor and low/medium severity Major process deviations unassisted, and the supervised completion of high severity Major and Critical process deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to prevent recurrence.
Technical writing for the educated but uninformed reader, translate difficult and complex scientific events into a brief and cohesive report as a finished product. Accurately capture immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report.
Gathering data from various sources across the site, performing Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, assessing the event for impact to Safety Identity Strength Quality Purity (SISQP), performing trending analysis, identifying Corrective and Preventative Actions to reduce deviation recurrence, performing Risk Assessments, Causing Mapping, and interviewing.
Managing multiple projects and timelines concurrently. Ability to adhere to the standard timeline and elevate actions appropriately for timely resolution. Participation in the Daily Management meetings to update leadership or current deviation statuses.
Routine interaction with the customer, including compilation of Power Points to communicate investigational current status, alignment meetings, facilitated reviews, CAPA discussions, and comments resolution.
Working on the manufacturing floor for data gathering, observing processes for investigations, and conducting associate interviews.
Meeting facilitation and participation, aligning internal review team and area subject matter experts on an agreed investigational path forward. Complex conflict resolution, problem solving in a cross-functional setting, and ability to keep the meeting on track to achieve objectives of varying difficulty. Attendance and occasional leadership of the daily management system and participating/leading the deviation review board.
Perform other duties as assigned.
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