HireTalent
Overview
Job Title:
Sr. Quality Records Investigator
Job Location:
Houston, TX
Job Duration:
6 month contract with extension possibilities. (On w2)
Shift:
Monday - Friday 8am - 5pm (100% 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.
Responsibilities
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, perform Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, assess the event for impact to Safety Identity Strength Quality Purity (SISQP), perform trending analysis, identify Corrective and Preventive Actions to reduce deviation recurrence, perform Risk Assessments, Process Mapping, and Interviewing.
Management of multiple projects and timelines concurrently. Ability to adhere to standard timelines, and escalate actions appropriately for resolution in a timely manner. Participation in Daily Management meetings to update leadership on current deviation statuses.
Routine interaction with the customer, including compilation of PowerPoints to communicate investigational current status, alignment meetings, facilitated reviews, CAPA discussions, and resolution of comments.
Work on the manufacturing floor for data gathering, observing processes for investigations, and conducting associate interviews.
Meeting facilitation and participation, aligning internal review teams and area subject matter experts on an agreed investigational path forward.
Complex conflict resolution and problem solving in a cross-functional setting, with the ability to keep meetings on track to achieve objectives of varying difficulty.
Attendance and occasional leadership of the daily management system and participation/leadership of the deviation review board.
Perform other duties as assigned.
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Sr. Quality Records Investigator
Job Location:
Houston, TX
Job Duration:
6 month contract with extension possibilities. (On w2)
Shift:
Monday - Friday 8am - 5pm (100% 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.
Responsibilities
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, perform Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, assess the event for impact to Safety Identity Strength Quality Purity (SISQP), perform trending analysis, identify Corrective and Preventive Actions to reduce deviation recurrence, perform Risk Assessments, Process Mapping, and Interviewing.
Management of multiple projects and timelines concurrently. Ability to adhere to standard timelines, and escalate actions appropriately for resolution in a timely manner. Participation in Daily Management meetings to update leadership on current deviation statuses.
Routine interaction with the customer, including compilation of PowerPoints to communicate investigational current status, alignment meetings, facilitated reviews, CAPA discussions, and resolution of comments.
Work on the manufacturing floor for data gathering, observing processes for investigations, and conducting associate interviews.
Meeting facilitation and participation, aligning internal review teams and area subject matter experts on an agreed investigational path forward.
Complex conflict resolution and problem solving in a cross-functional setting, with the ability to keep meetings on track to achieve objectives of varying difficulty.
Attendance and occasional leadership of the daily management system and participation/leadership of the deviation review board.
Perform other duties as assigned.
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