Reconciliation Specialist (Blending) Second Shift ($36,467.00 - $70,967.00) Plus $2.00 Shift Differential Location: Hobart, NY (Pharma) - USA036
Job Description: Summary: Performs review of medium to high complexity for all manufacturing batch records at appropriate stages 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 meet reliability standards or require modification. Performs trending and audits of processes/systems and takes appropriate action to correct any identified issues. Leads investigations of product quality related events to determine scope of impact, corrective actions, and rationale to support product disposition. This is an independent role with progressive responsibilities.
Essential Functions: Engages with and assures all In-Process Batch Records meet compliance requirements. Completes investigations in a thorough and timely manner, identifying corrective actions. Reviews batch records for compliance, completeness, accuracy, and deviations from approved manufacturing instructions and SOPs prior to final product release. Coordinates with supervisors, team leaders, technicians, and operators to obtain corrections or missing information/sign-offs in the batch folder. Monitors and ensures compliance to procedures and policies, including coaching and mentoring operators and technicians on proper batch record documentation. Assists in training technicians and operators on proper documentation. Reviews quality control checks during and after production. Ensures timely flow of records and product to the next stage. Maintains various reports for Supervisor/Manager by inputting/updating pertinent data. Performs compliance audits for accuracy and completeness by reviewing batch records and documentation. Completes all assigned tasks and documentation according to standard. Minimum Requirements: Education: High School Diploma or equivalent required. Bachelor or Associates Degree preferred.
Experience: Level 1: 1 to 3 years of related experience.
Level 2: 2 to 4 years of related experience.
Level 3: 4 to 6 years of related experience.
Level 4: 6+ years of related experience.
Preferred Skills/Qualifications: Knowledge of cGMPs. Basic computer skills including Word, Excel, and database software. Ability to effectively communicate at all organizational levels. Attention to detail and accuracy. Organizational Relationship/Scope: Problem solving, analytical skills, and attention to detail are crucial for this role. The candidate should be able to effectively manage processes and focus on critical tasks that add value.
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