Wendy Escarfullery Email & Phone Number

Allentown, Pennsylvania Area

Duties and Responsibilities:• Performs inspection of manufacturing, packaging, and testing activities associated with the manufacturing of solid dose and liquid drug products• Sample raw materials and packaging components• Release controlled printed materials to packaging• Performs real-time batch record review• Performs clearance of processing rooms, equipment and materials• Swabs equipment and submits to laboratory; coordinates between laboratory, formulation, and production• Monitors equipment/instrumentation• Verifies and analyzes data entries on quality records using Analyze production data using of one or more of the seven basic Quality Tools (Cause-and-effect diagram, check sheet, control chart, histogram, Pareto chart, Scatter diagram, and Stratification)• Assists with Investigation Reports utilizing standard investigational tools (Kepner Tregoe Analysis, 5 Whys, 6 Ms, Ishikawa (fishbone) diagram). Provide input into corrective actions.• Reviews/audits all data obtained during quality assurance activities to ensure consistency with company policies and procedures (completed batch records, in-process test results, AQL attribute inspection, etc.). • Revises departmental procedures (SOPs) as necessary to ensure compliance to regulatory standards and company policy.• Develops new approaches to solve problems identified during quality assurance activities• Maintains a working knowledge of government and industry quality assurance codes and standards• Assist QA Inspectors as needed• Submit samples, as required, to Analytical Services for testing• Carefully oversee the details of their assigned tasks to ensure accurate and timely documentation of manufacturing and inspection activities • Assists in the training of new/junior employees on GMP and Quality Assurance activities and the use of the seven basic Quality tools.• Other duties as assigned

• Performs inspection of manufacturing, packaging, and testing activities associated with the manufacturing of solid dose and liquid drug products• Sample raw materials and packaging components• Release controlled printed materials to packaging• Performs real-time batch record review• Performs clearance of processing rooms, equipment and materials• Swabs equipment and submits to laboratory; coordinates between laboratory, formulation, and production• Verifies and analyzes data entries on quality records using Analyze production data using of one or more of the seven basic Quality Tools (Cause-and-effect diagram, check sheet, control chart, histogram, Pareto chart, Scatter diagram, and Stratification)• Perform routine cGMP audits of warehouse and production areas• Monitors equipment/instrumentation• Review equipment/facility logbooks for competition and accuracy• Submit samples, as required, to Analytical Services for testing• Carefully oversee the details of their assigned tasks to ensure accurate and timely documentation of manufacturing and inspection activities • Assists in the training of new/junior employees on GMP and Quality Assurance activities

Operates independently from the production function, to assess and determine quality status of goods at each stage. Demonstrates independent review of quality related events. Reads and understands approved specifications/standards assigned to the particular project. Directs personnel assigned to the specific production line, concerning the quality attributes to be adhered to. Demonstrates the ability and skillset to direct minimally, two production lines. Consistently records quality related results in accordance with prescribed good documentation requirements. Determines the need and executes the halting of operations due to adverse quality conditions in an effective and timely manner. Performs final review and approval of line clearance activities. Performs product and component verification prior to, during and subsequent to production activities. Execute verification of product/component against approved quality document or record. Continuously assesses, enforces and report cGMP compliance events at the operational level. Executed AQL sampling for at least two lines. Performs required in-process/finished goods testing. Real time Batch Record review for at least two lines. Executes on line reconciliation verification for at least two lines. Capture and document room conditions covering at least two lines. Verifies the quality attributes of a line setup prior to the start of a shift. Backup responsibilities: Perform packaging line assembly tasks and other duties as assigned.

In-room task assignments for all clinical packaging employees to specific duties, based on their capabilities to ensure jobs are staffed with qualified people.Covers multiple rooms, if required.Stages components required for each job and ensure all specifications match the batch paperwork.Works in conjunction with QA and engineering to ensure components are staged in a timely manner and equipment is set up and ready when needed.Ensures that all production personnel working in their packaging rooms follows the instructions in the batch paperwork. Verifies each packaging room is within SOP and GMP requirements at the start of the job step, at the start of each shift, and after breaks and lunches.Performs in-room training for specific job functions for packaging personnel. Ensures each employee assigned to a task fully understands their responsibilities. Completes all required documentation in conjunction with QA. Performs in-process inspections, as required. Evaluates rejected product, to either pass acceptable material or arrange for the correction of any problems. Ensures adequate materials and supplies are available for the completion of assigned production runs. Documents reconciliation of all materials ensuring limits in the SOP`s, or customer specific requirements are met at job completion. Participates in required training sessions for SOP’s, quality and safety.

Reviews batch paperwork and follows supervisor instructions to understand and perform the necessary packaging procedures required for assembly of each study.Performs manual and automated filling and packaging of blistered and bottled pharmaceutical products independently and approves in-process products at other stations.Performs and ensures proper card and drug placement using various secondary card sealing machinery.Accepts or rejects in-process clinical supplies according to acceptability standards determined by Good Manufacturing Principles, customer requirements, and Standard Operating Procedures.Labels and assembles both blinded (following a randomization schedule) and open clinical supplies in conjunction with other FCS personnel ensuring proper label placement and proper documentation of labeling activities. Accurately counts out and prepares packaging supplies to ensure proper accountabilities prior to and at the completion of a job order. Assists Quality Assurance personnel, Production Supervisors and Room Leaders in staging and reconciliation of components as required.Performs final check of work in-process and finished products and then packs these goods into appropriately labeled containersPerforms in-process inspections of clinical supplies in primary and selected secondary operations. Documents the results of these inspections on the required batch records to ensure compliance with the customer supplied instructions.Assists Engineering, Quality Assurance, Production Supervisors and Room Leaders, in performing necessary documentation of job related activities as required. Assists in tracking room performance by making entries into the Room Activity program.

Processed all financial transactions in an accurate and timely manner adhering to all bank policies and procedures. Prioritized multiple customer demands to provide maximum service levels to all customers which includes engaging customers promptly, in a professional manner, within the Brand Culture. Identify customer needs and sell/refer appropriate products and services.Maintained a thorough knowledge of all products and services available to customers along with systems and procedures pertaining to the Community Office. Assisted with daily responsibilities of the Branch and assume additional responsibilities as assigned.Provided guidance/supervision/training to less experienced Tellers as requested.

Retained a thorough knowledge of all products and services available to customers along with systems and procedures. Prioritized multiple customer demands to provide maximum service levels to all customers which includes engaging customers promptly, in a professional manner.Processed all sales transactions in an accurate and timely manner.Opened and closed the kiosk.