Manufacturing Investigation Writer - (US-NY-Pearl River - 10965)

Minimum Education: None
Jobcode: sunnj4430NY_ManufactringWrire
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 The Lead Investigator researches, expedites, solves, and tracks manufacturing discrepancies and resulting commitments within their respective PPU or assignment.
The Lead Investigator initiates Manufacturing Investigation Reports (MIR) and coordinates the actions required for its resolution.
The position works closely with Operations and Quality Assurance, ensuring that all investigations are performed according to corporate and site guidelines. Responsibilities:  Ensures that MIRs accurately identify all processing and manufacturing deficiencies to determine and classify root cause. Gathers, coordinates, and reviews validation & batch documentation, standard operating procedures, testing and manufacturing specifications, testing results, training & calibration records, regulatory & Level I and II policies.
Coordinates efforts for change controls, work orders, and purchase orders related to investigations. Writes clear concise summaries of investigations, product impact assessments, and commitments.  Provides solutions for potential and identified problems. Track, trend and evaluate manufacturing discrepancies and work to eliminate root causes.

This includes tracking and trending PPU as well as plant-wide discrepancies, developing appropriate solutions, and facilitating the implementation of such solutions. Assess the impact of discrepancies on products or processes and recommend product disposition. Determines, recommends and may ensure that corrective actions and/or commitments have been taken and completed.  Evaluates processes and proactively initiates actions to prevent or minimize the impact of deviations through observations and communications with production personnel and PPU management. Communicates immediately with PPU management about all manufacturing discrepancies that impact product. Prepares status reports to update PPU personnel as necessary.  Manages the MIR commitment tracking system for the PPU to ensure timely resolution of compliance related issues per SOP.
Conducts internal audits of manufacturing and packaging operations as applicable.

Focuses on basic cGMP, compliance, safety, housekeeping, logbooks, and manufacturing and packaging instruction documents. Maintains regulatory compliance by initiating MIRs as needed and ensures that PPU personnel document all manufacturing discrepancies, resulting changes, whether process, equipment, or procedural, as per regulatory and company policies.  Monitors the status of all MIRs pending approval to ensure investigations are completed in a timely manner allowing the facility to meet product attainment as defined by management. Ensures investigations are initiated and resolved within the allotted time frame per applicable SOP. Ensures that all SOP mandated timelines are followed.

Monitors quality issues and investigates as appropriate.  Attends weekly MIR Council meetings as needed; provides tracking metrics and follow-up of outstanding MIRs and commitments. Interacts and coordinates with appropriate personnel including manufacturing, QA/QC, regulatory, and technical services.
Participates in cross-functional team reviews to resolve MIR issues.

Pertinent Skills:
? Technical Knowledge/Technical Writing Skills
? Encourages Innovation/ Problem Solving
? Self Motivated ? Communication with Impact
? Operational Decision Making
? Time Management