Job Title

Requisition

Location

Additional Locations

Job Description

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.

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

• 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.
• 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.
• 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 next stage.
• Maintains various reports for Supervisor/Manager by inputting/updating pertinent data
• Performs compliance audits for accuracy and completeness as reviewing batch records and documentation, ensuring identified issues are elevated to the appropriate level
• 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).
• Prioritizes and processes work according to the production schedules; re-prioritizes as schedules change.
• Understands the inventory and planning systems and has an active account in the Business Planning and Control System (BPCS).
• Communicates with production supervisors, team leaders, technicians, and Quality Assurance (QA).
• Works and communicates effectively in a team environment.
• Promotes and adheres to safety requirements.
• Communicates any issues to the oncoming shift.
• Completes all assigned tasks and documentation according to standard.
• Performs other duties as assigned by management or as required by the position.

Position Level Summary:

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Reconciliation Specialist Level I: Is able to perform all Essential Functions

Reconciliation Specialist Level II: Is able to perform all level I functions in addition to:

• Communicate with other departments to provide information and assist in maintaining efficient flow of paperwork to support production/processing functions.
• Drives and participates in continuous improvement and quality initiatives.
• Communicates any issues to the oncoming shift by preparing and performing shift turnover.
• Uses Trackwise for exceptions, CAPAs, Change Controls and DMS.
• Promotes effective working relationships and communication in a team environment.
• Conducts training with others within the department.

Reconciliation Specialist Level III: Is able to perform all level I and ll functions in addition to:

• Maintain various reports for Supervisors and/or Managers. Attend meetings to report out on any concerns.
• Follow-up on incidents to ensure resolution to allow folders to release to the next stage.
• Communicate with other departments to provide information and assist in maintaining efficient flow of paperwork to support production/processing functions.
• Drives and participates in continuous improvement and quality initiatives.
• Prepare and perform shift turnover.

Education: High School Diploma or equivalent required. Bachelor or Associates Degree preferred with equivalent combination of education, directly related experience and competencies may be considered.

Experience:

Level 1: 1 to 3 years of related experience to perform the essential functions of the position within quality and quantity standards.

Level 2: 2 to 4 years of related experience to perform the essential functions of the position within quality and quantity standards

Level 3: 4 to 6 years of related experience to perform the essential functions of the position within quality and quantity standards

Preferred Skills/Qualifications:

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• Knowledge of cGMPs
• Knowledge and understanding manufacturing and packaging instructions, processes, SOP's, etc.
• Knowledge, understanding and application of quality principles
• Knowledge, understanding and application of continuous improvement methods
• Knowledge, understanding and application of RCA tools and methods
• Knowledge, understanding and application of ANSI tables, inspections and performance of product AQL

• Basic computer skills including Word, Excel and database software.
• Understanding of documentation and processes for production/packaging.
• Understanding of manufacturing instructions and SOP's.

• Interpersonal skills.
• Ability to effectively and professionally communicate at all organizational levels in a variety of settings and formats.
• Attention to detail and accuracy.
• Perform mathematical functions of medium complexity: add, subtract, multiply and divide all units of measure, including metric.
• Ability to identify and resolve people and task related issues involving non-standard situations.

Problem Solving: Rigorously and systematically connects information, processes and events by organizing divergent information and searching for common themes, patterns, and causal connections. Undertakes a complex task by breaking it down into manageable parts in a systematic, detailed way. Thinks of several possible explanations or alternatives for a situation and anticipates potential obstacles and develops contingency plans to overcome them. Uses intelligence, common sense, hard work and tenacity to solve particularly difficult or complicated challenges.

Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.

Keeping on Point: Can quickly separate the mission-critical from the nice to do and the trivial; quickly senses what's the next most useful thing to work on; focuses on the critical few tasks that really add value and puts aside or delays the rest.

Influencing Others: Moves people toward willing involvement in a particular course of action using techniques that appeal to logic, values or emotion; presents arguments that address others' most important concerns and issues and looks for win-win solutions; involves others in a process or decision to ensure their support; identifies and proposes solutions that benefit all parties involved in a situation; accurately anticipates the implications of events or decisions for various stakeholders in the organization and plans accordingly.

Process Management: Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources.

Attention to Detail/Focus: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small. Monitors and checks work or information and plans and organizes time and resources efficiently. Double-checks the accuracy of information and work product to provide accurate and consistent work. Provides information on a timely basis and in a usable form to others who need to act on it. Compares observations of finished work to what is expected to find inconsistencies.

Listening: Practices attentive and active listening; has the patience to hear people out; can accurately restate the opinions of others even when he/she disagrees.

Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.

Written Communications: Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.