Reconciliation Specialist (Blending) Second Shift ($36,467.00 - $70,967.00) Plus $2.00 Shift Differential

Job Title

Reconciliation Specialist (Blending) Second Shift ($36,467.00 - $70,967.00) Plus $2.00 Shift Differential

Requisition

JR000014140 Reconciliation Specialist (Blending) Second Shift ($36,467.00 - $70,967.00) Plus $2.00 Shift Differential (Open)

Location

Hobart, NY (Pharma) - USA036

Additional Locations

Job Description

Summary

Performs review of medium to high complexity for all manufacturing batch records at appropriate stages in order to ensure accuracy, completeness, and compliance to standards. Takes appropriate action to correct any identified issues. Performs tracking, trending and recommends and/or implements corrective actions.  Assists with production compliance activities as required.

 Ensures quality procedures are followed and evaluates the organization's products, materials, and facilities for compliance. Determines if current methods and techniques result in meeting reliability standards or require modification. Performs trending and audits of processes/systems and takes appropriate action to correct any identified issues. Performs and leads investigations of product quality related events to determine scope of impact, corrective actions and rationale to support product disposition. Lead and assist with production safety, compliance and improvement initiatives as required. This is an independent role with progressive responsibilities. Individuals are expected to perform the necessary functions of the role with minimal oversight.

Essential Functions

Engages with and assures all In-Process Batch Records Meet Compliance Requirements

Investigations completed in a thorough and timely manner, corrective actions identified.

• Reviews batch records for compliance, completeness, accuracy and for any deviations from approved manufacturing instructions and Standard Operating Procedures (SOP’s) prior to final product release.
• Lead and participate on equipment/process RCA Investigation Teams
• Coordinates with supervisors, team leaders, technicians, and operators to obtain corrections or missing information/sign-offs in the batch folder.
• Monitor and ensure compliance to procedures and policies, including coaching and mentoring operators and technicians on proper batch record documentation.
• Lead and participate on safety incident RCA Investigation Teams
• Assists in training technicians and operators on proper documentation.
• Lead, investigate, write and provide support for Triages, SCARs and Customer Complaints

• Reviews quality control checks during and after production.
• Ensures timely flow of records and product to next stage.

• Lead, investigate, write and provide support for all Exceptions levels
• Perform in-depth trending through Triage and Exception data to identify gaps and corrective actions
• Perform risk assessments to support dispositions of Triages and Exceptions
• Lead, identify, implement and execute simple and standard CAPAs

Operations compliant with Regulatory Requirements

• Maintains various reports for Supervisor/Manager by inputting/updating pertinent data
• Monitor compliance for safety requirements (I.e. PPE, fall protection, trip hazards, etc.)
• Performs compliance audits for accuracy and completeness byas reviewing batch records and documentation, ensuring identified issues are elevated to the appropriate level
• Perform Gemba Walks ensuring identified issues are escalated and corrected
• Monitor and ensure compliance to procedures and policies, including coaching and mentoring operators on proper documentation

Processes and Tasks Effectively Managed, Results and Changes Managed:

• Ensures accurate and up to date tracking in the Batch Record Activity Tracker (BRAT), of all batch records through the Manufacturing and Packaging process (as applicable).
• Coordinate with operators, supervisors, team leaders, and QA to obtain corrections or missing information/sign-offs in the batch folder
• Prioritizes and processes work according to the production schedules; re-prioritizes as schedules change.
• Prioritize and process work according to the production schedules; re-prioritize as schedules change
• Understands the inventory and planning systems and has an active account in the Business Planning and Control System (BPCS).
• Maintain daily communication and status updates on all open items. Ensure accurate and good communication during shift turnovers
• Communicates with production supervisors, team leaders, technicians, and Quality Assurance (QA).<