Wanda I Andino

Lebanon, PA

717-***-****

adycyu@r.postjobfree.com

Professional Summary

Experienced and reliable Quality Assurance professional with over 15 years of experience working in companies to ensure the highest quality outcomes possible. Highly skilled and detailed oriented professional with solid QA/QC, analytical, and statistical skills to identify, capture, analyze, and report critical process metrics and key performance data. Excellent interpersonal skills with the ability to build positive relationships at all levels both internal and external to the organization. Ability to communicate clearly and concisely in multiple media-verbal, written, etc. Excellent organization and time management skills with the ability to prioritize work assignments in a fast-paced work environment. Highly Skilled in performing and conducting company health and safety procedures.

Professional Skills

● Experienced in cGMP procedure

and regulations

● Proficient in Spreadsheets,

Databases, Labeling Procedures,

Batch Review, Record

Documentation, Batch Record

Issuance, and Batch Record

Release.

● Experienced in Validation Protocol.

● Customer Complaint Investigation.

● Generated Certificate of

Conformance and Analysis

according to customer requirement.

● Performing technical review of

cGMP documentation for

completeness and compliance to

cGMP as outlined.

● Collected product samples

● Laboratory Quality Control

Department.

● Working with plant Quality Systems

including; SOP's, Master Control,

Works Instructions, Audit Functions,

SAP, Blue Mountain, Track wise, PB,

Quality Management Regulations:

ISO-9001-13485.

● Regulatory requirements (21 CFR

11, 110, 111 and 210,211).

● Laboratory Techniques such as:

Specimen collection and processing,

sterilization, aseptic, and swapping

procedure.

● Conduct physical supply inventory,

maintaining inventory, stock and

property account records of the

facility. Knowledge of

HIPPA/OSHA/FDA Regulations.

● Medical Terminology.

● LIMS (Laboratory Information

Management System), CGM

LabDAQ Software, Dataflow, Oracle,

Agile. Batch Vs Stream Data

Processing, Prism Label Design,

Barcode and Print Management

Software, and Adobe Acrobat.

● MS Office Suite, MS Project,

Outlook, Excel, MS Excel

Spreadsheets, SharePoint, Envi,

Epic, SOPs, SAP Track wise,

Master Control Compliance Wire,

Laboratory Data Management

System, Cloud, PB, Blue Mountain,

Microsoft SQL Server, Agile, Oracle,

Project Management System, ERP

Systems, and Clinical Trial

Documentation System).

● Labeling and documentation

accuracy of Master Data in SAP

● Electronic Scanner Systems.

● Insurance Procedure/Verification.

● SAP Business Workflow.

● Lab Centrifuge Machine, Optical

Comparator, Microscope,

Thermometer, Caliper, and

Calibration/Documentation, Brix

(Viscosity) using Refractometer

Water Activity Meter (AquaLab)

Bostwick Meter.

● HACCP Regulation and Procedure.

● Computer Systems Validations

including Pharmaceutical and

Biologics Manufacturers, Medical

Device Manufacturers, Clinical

Research Organizations, and GLP

Laboratory.

● MS Access Databases

● Management, Research &

Development and Analysis Skills.

● Inventory Control Management.

● Warehouse Operations.

● Supply Chain Management.

Logistics Management.

● Data Entry and Customer Service.

● Pharmacovigilance Safety

Work History

Walmart DC - Lebanon, PA

06/2022 - 12/2022 (Contract)

● Communicate with (or to) individuals or groups verbally and/or in writing (e.g. customers, suppliers, associates, truck drivers).

● Ensure inbound trailer information is accurate by entering, editing and /or removing trailer information in the system; and creating, updating, and sending appointment schedules to carriers.

● Monitors and processes deliveries by scheduling and maintaining log of delivery appointments; checking-in and releasing drivers; tracking late deliveries; and preparing, reviewing, and analyzing reports and other paperwork.

● Provides administrative support by performing general clerical duties ( filing, keying, faxing); entering data into multiple systems (email, spreadsheet, word processing, excel, Scheduler, GDM, Shore, YMS, Blue Yonder).

● Scheduling appointments for inbound/outbound freight and maintaining appointment logs; and preparing, reviewing, maintaining, and analyzing reports, purchase orders (PO) and other paperwork.

● Prepares, reviews, and analyzes receiving/billing documentation and reports by verifying delivery bills and receiving documentation; researching and resolving discrepancies; completing necessary paperwork for shipping/receiving process (outbound bills, inbound drop trailer paperwork, purchase orders); and ensuring backup documentation.

● Ensures that all shipping and receiving documents are completed accurately and on time.Maintain legible and accurate records, data and logs relative to shipping and receiving activities.(BOL).

● Training new associates.Maintain the facility dock door control board accurately all times.

● Promotes safety and reports unsafe conditions.

● Ensure inbound trailer information is accurate by entering, editing and /or removing trailer information in the system; and creating, updating, and sending appointment schedules to carriers.

Lancaster Orthopedic Associate – Lebanon, PA

Inventory Specialist / 03/2022 - 05/2022 (Contract)

● Maintains inventory primarily in inpatient units and replenishes supply carts.

● Issuance storeroom supplies and assists in general storeroom functions as necessary.

● Lead and control the outflow and inflow of inventory, as well as shipment, loading, and storage activities for designated areas.

● Maintain accurate inventory levels, conduct weekly cycle counts, make ordering decisions for goods, and ensure the optimal inventory is ready for use.

● Keep track of inventory using computerized inventory systems, and ensure all items are appropriately received and stored.

● Produce and analyze inventory reports to establish (safety stock) levels for each item.

● Conduct instrument set audits to ensure set inventory accuracy of at least 99.98%.

● Examine and investigate inventory discrepancies.

● Review shipping or receiving orders and requests for movement of materials and products.

● Administer operational procedures for activities, such as verification of incoming and outgoing shipments, handling and disposition of materials, and keeping warehouse inventory current.

● Evaluate physical condition of warehouse and equipment and prepare work orders for repairs and requisitions for replacement of equipment.

● Provide guidance, training and direction to employees.

● Assist with investigating causes of budget variances and develop solutions to resolve as well as prevent further variances caused by inefficiencies, technical or procedural errors or other causes

● Monitors, rotates, and remove all outdated and overstock materials and verifies that perioperative services par levels are adjusted accordingly

● Restocks of all materials used for patient care in the perioperative and recovery department.

● Monitor oxygen, carbon dioxide, and nitrogen tank level daily and order replacement tanks as needed.

● Response for emergently (STAT) equipment, supplies, and instruments.

● Maintain record of purchase order, requisitions, and product literature

● Communicate with vendors regarding backorders and anticipated release dates for perioperative materials.

● Communicate to perioperative leadership any identified quality improvement projects relative to perioperative materials management

● Follow policy and steps with product recalls.

● Maintain privacy and confidentiality of all appropriate information

● Other duties as assigned and required

Volt Staffing – Jonestown, PA

Packer/Quality Control / 10/2021 - 03/2022 (Contract)

● Picking, inspecting and packing products.

● Labeling and boxing products prior to shipping.

● Continually stocking/unstocking shelves

● Attending to and processing shipments

● Helping to complete shipments, process and load orders

● Reading orders and placing them in the proper delivery areas

● Preventing on-the-job injuries by maintaining safety best practices across all areas of operation.

● Coaching and mentoring peers.

● Quality Control inspection procedure.

Raland Compliance Partners - Remote

QA Batch Record Reviewer / 04/2021 - 06/2021 (Contract)

● Review and approval of executed batch records.

● Issuance production batch records and product labels to Operations.Responsible for disposition of incoming production materials.

● Responsible for release activities for site manufactured drug products.

● Provide oversight of the QA shop floor program.

● Strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

● Planning and organizing, decision-making, and building relationships.

● Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management. Altran Technology - Remote

QA Batch Record Reviewer / Clinical Packaging Coordinator / 02/2020 - 11/2020 Contract

● Review and approval of executed batch records.

● Issuance production batch records and product labels to Operations.

● Responsible for disposition of incoming production materials.

● Responsible for release activities for site manufactured drug products.

● Provide oversight of the QA shop floor program.

● Perform critically review investigations, interpret results and generate technical conclusions.

● Consistent with Quality risk management principles.

● Planning and organizing, decision-making, and building relationships.

● Quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

● Coordination, scheduling, planning and processing of internal packaging process orders and associated activities to meet client deadlines and facilitate the final release of clinical trial supplies.

● Control and monitor production processes and equipment; resolve problems or correct abnormal conditions, conduct basic troubleshooting and escalate problems appropriately.

● Participate in equipment validation and system user acceptance testing as required.

● Complete and review electronic batch documentation, equipment log books and other documentation relevant to the production process for all stages of production for both product and labels.

● Develop and apply a working knowledge of relevant electronic system operations, including SAP, temperature monitoring and product stability information systems.

● Follow the clients GMP related quality standards of relevant packaging, label authoring, printing, inspecting and logistics environments.

● Perform internal and external regulatory environment procedures pertinent to clinical trials and pharmaceutical development.

● Support internal audits and regulatory inspections.

● Perform blinding principles and conduct in-process controls to maintain blinding integrity. Proclinical – Marietta, PA

Quality Assurance Specialist / 04/2019 - 07/2019 - (Contract)

● Educate and train manufacturing/process engineering personnel to execute production in Full accordance with cGMP and quality system to ensure real-time compliance.

● Represent our QA when managing issues that require immediate corrective action.

● Ensure such action taken is appropriate and appropriately documented.

● Reviews un-executed/executed batch records and quality control testing for compliance with internal SOPs and specifications.

● Monitor Operations personnel for adherence to SOPs

● Report back to the Manager of QA as well as area functional management as to personnel performance, highlighting those areas and individuals in need of improvement.

● Review and approve Document Change Notifications for SOPs, test methods, raw material specification, protocol (stability, validation, etc.) and batch records. Reviews and approves SOPs test methods, raw material specifications, protocol and executed validation documentation.

● Author or revises SOPs.

● Performs manufacturing area and labeling clearances as well as inspection of material.

● Review and approve CAPAs, Deviation, Change Controls, Equipment Excursion Reports.

● Assists in performing investigations.

● Performs internal audits and weekly walkthroughs.

● External audits for Supplies qualification.

● Respond or manage responses to clients regarding manufacturing and/or documentation issues.

● Assists in developing and delivery training.

● Assists tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs.

● Develop and/or maintain Quality System metrics for Management Review.

● Provides on the floor support to manufacturing operations.

● Perform QA visual inspection activities associated with clinical commercial drug products

● Participate in regulatory and client audits.

Kelly Services – Lititz, PA

Quality Assurance Specialist / 07/2018 - 92/2019 (Contract)

● Plan, execute, and oversee product inspection and testing for quality and conformance to specifications and deliverables.

● Assist operations by tracking, documenting, and reporting quality levels as well as CSR, environmental, and health and safety KPIs.

● Investigate reports of product quality issues and ensure resolution in accordance with company guidelines and regulatory requirements.

● Develop or update procedures for capture, investigation, and documentation of product complaints.

● Monitor risk-management procedures, maintain problem logs, and report issues to managers and product developers.

● Provide training and support to quality assurance team members that covers systems, policies, procedures, and core processes

Languages

English/Spanish

Education

Lancaster County Career & Technology Center, Lancaster, PA 08’2009 - 2010 - Medical Administrative Assistant Diploma Preparatory Career Institute - Humacao, PR

08/1987 - 06/1988 - Secretarial Science Diploma

Ana Roqué High School - Humacao, PR

08/1982 - 05/1985 - GED

Contact this candidate