Customer Service Quality Assurance

Jeanene Clark

Philadelphia, PA *****

*************@*****.***

Cell: 267-***-****

SUMMARY:

Jeanene is an extensive experience in inventory management, clinical packaging as well as commercial.

Worked with materials group to assure material movement between locations are completed as required and questionable inventory is cleaned up

Identify opportunities for improvement and efficiencies in inventory management, capacity utilization and purchasing as applicable

Responsible for receiving, coordinating release and distributing GMP materials to support clinical production within Bio pharm R&D and reviewing item master.

Experience in internal and domestic shipments of bulk drug substances, reference standards and drug product under GMP requirements.

Great with time management, communication across all departments and strong customer service

EDUCATION:

G.E.D Diploma, Temple University, Phila, Pa

Phlebotomy/Medical Lab

Community College of Philadelphia, PA

Direct care worker training (Caresify)

Lean Six Sigma (White belt)

CERTIFICATION:

Catalent Pharmaceuticals

QA Auditor training/Certificate

GlaxoSmithKline R&D

Lean Six Sigma, White Belt, and introduction to GMP

On Assignment Lab Support (Online Courses)

GEN LAB, HCLAB, IIPPLAB, and LABSAF

Phlebotomy Internship/Certificate

J.F.K Memorial Hospital

CPR/AED

ISO Cleanroom 7,8,9

SKILLS:

Good communication skills, both written and verbal

Strong interpersonal skills and is comfortable working in a team environment

Good computer skills

Knowledge of MS Word, MS Windows, Excel, Lotus notes, LIMS (laboratory inventory management system), CDMS, COMET (Global inventory System), MM data base, Plateau data base, QAD, SAP, track wise

Basic knowledge of Lean Six Sigma Methodologies Knowledge of Kaizen project, 5 S projects, and business unit cell development

Good knowledge of the application of FDA cGMP’s and cGLP’s on a yearly basis

Experienced in both commercial and clinical manufacturing and packaging

Knowledge of cGMP cleaning of manufacturing suite

Knowledge of CIM Scan (Serialization)

Knowledge of Antares systems (production)

Comfortable working in a dynamic environment with many conflicting priorities

Knowledge of CFR 21 Pt. 58, 211 and 210

Laboratory Safety &Chemical Hygiene (E Learning/UP On-Line)

Manual Handling (On- Line) – CDMS training

ISO 7/8/9 experience- (Class 10,000 and 100,000)

Laboratory Aseptic qualified

Laboratory safety online course

Class C/D parenteral use for sterile manufacturing of clinical supplies

Raw material sampling

International and domestic shipping

CPR/First Aid certified

Batch record review (Pre and Post)

Knowledge of pipetting and cell plating

Professional Experience:

Wuxi Apptec (Cell Gene Therapy)

Position: Senior Shipping Coordinator July 2022- Present

Coordinating with other members of the shipping department to ensure that all shipments are properly prepared

Creating reports on shipping activities such as tracking shipments, compiling statistics about shipping volume or rates, and monitoring employee performance

Arranging for pickup or delivery of shipments using a variety of methods such as trucking companies, railroads, airlines, or shipping lines

Communicating with clients to ensure that they receive their orders on time

Interacting with insurance companies to settle claims for damaged items

Preparing invoices for shipping costs and keeping track of them for accounting purposes

Maintaining records of inventory levels and purchasing new inventory when necessary

Maintaining a database of customer information such as shipping address and contact information

Assisting with the planning and scheduling of shipments including documentation, pick-up arrangements, customs clearance procedures, etc.

University of Pennsylvania Hospital

Position: Clinical Engineering Coordinator August 2020- July 2022

Answering phone calls, transferring callers as appropriate

Greeting customers and visitors to the office, ensuring guests are comfortable and are connected with the right office personnel

Managing schedules for conference and community spaces

Monitoring and ordering inventory for office and break room supplies

Managing incoming and outgoing correspondence, including emails, faxes, mail and packages

Filing and organizing records, invoices and other important documentation

Submitting work orders and scheduling repairs for general office space and equipment

Ordering repairs for office equipment and maintenance, connecting with and escorting vendors

Scheduling of technicians for work order calls

Facilitator / overseer of the repair /PM of essential OR accessories and equipment

Coordinate Tech work schedules/ work flow.

Customer service liason.

Oversee office and shop work materials for CE team

Maintain accurate inventory levels for CE shop.

Universal Pure April 2020- July 2021

Position: Quality Assurance Technician

Performs QA Tech position duties for products and systems

Is responsible for all other duties as assigned.

Ability to prioritize and perform position responsibilities accurately and to deadline.

Provide assistance to local and corporate management in carrying out changes to the food safety system of the facility; give assistance in creating, reviewing, authenticating, and maintaining food safety system documents, including standard operating procedures (SOPs) and programs working in collaboration with the quality assurance team; provide assistance in maintaining document registers and documentation

Provide daily monitoring of facility and personnel to ensure compliance to the food safety system of the facility; perform formal audit on cGMP.

Ensure training of facility personnel on cGMPs, Risk Preventive Controls, Hazard Analysis, pre-requisite programs, and other applicable food safety system elements as required.

Collect and analyses product samples as required, as well as document information derived from analysis.

Safely keep records of all facility analytical results; immediately report results discovered to be out of specification to the QA supervisor.

Provide documented reports of analytical results to the QA supervisor, also responsible for tracking and reporting data trends.

Responsible for inspecting raw materials coming in; assisting in investigating non-conformance and complaint about product; and provide leadership for the facility team in performing self-audits.

Aid in hosting visitors to the facility, including regulatory agency representatives and customer representatives, function as main host for the facility’s third-party auditors.

Knowledge and understanding of applicable FDA regulations and cGMP

Possess innovative, resourceful, and proactive disposition, committed to ensuring continuous improvement of capacity and delivering quality service.

Facilitator / overseer of the repair /PM of essential OR accessories and equipment

Coordinate Tech work schedules/ work flow.

Customer service liason.

Oversee office and shop work materials for CE team

Maintain accurate inventory levels for CE shop.

PCI Pharma Services I Jan 20 – April 2020

Position: Inventory Planner / Leader

Identify opportunities for improvement and efficiencies in inventory management, capacity utilization and purchasing as applicable

Leads the operations and activities of the production team within the room to ensure that throughput ls maximized, while sustaining safety, quality, and timelines

Reviews and reads MPI’s, relevant SOP’s and the shop floor packet prior to job start-up To identify and understand all production, validation, and/or special requirements (ex: temperature, humidity etc.)

Determines the placement of personnel on the production line according to critical skill set required at each line station

Verifies line clearances and completes required line clearances and use begin forms prior to start- up

Checks all incoming components against the batch record to verify that they are correct

Documents receipts in the batch record

Perform start-up and in process quality inspections (hourly), testing and sampling

Perform periodic reviews of the batch record throughout the production operation to ensure cGMP compliance

Verify all coded information (Serialization) are set correctly throughout the packaging line and completes qualified line challenges

Ensure that equipment calibration dates in preproduction rooms are within required specifications

Ensures that all packaging strictly conforms to MPI and PCI specifications

Documents and monitors, helps control constraint downtime

Monitors material and waste quantities

Provides production updates on a regular basis throughout the shift

Reviews batch record and reconciles all material at the end production

Perform lot change, product change, product change exception and logbook inspection

Caresify LLC Apr 19 – Present

Position: Direct Care Worker

Monitors patient condition by observing physical and mental condition, intake and output, and exercise

Supports patients by providing housekeeping and laundry services; shopping for food and other household requirements; preparing and serving meals and snacks; running errands

Help clients get dressed and undressed and maintain proper clothing

Provide and assist with personal services such as bathing and grooming

Accompany clients to their doctor visits and give medications

Oversee the administration of prescribed medications to clients

Assist clients who are unable to handle the day-to-day homemaking duties in their homes

Follow a specified care plan for the client and report on completed tasks after each visit

Catalent Pharmaceuticals Philadelphia, PA May 19 – June 19

Position: Quality Assurance Document Control

Interpret and implement quality assurance standards and procedures

Store, manage and track company documents

Organize, copy, scan and maintain documents

Review and maintain the accuracy the records, editing where necessary to ensure they are up to date

Manage the processes around documentation within the organization

Scan, image, organize and maintain documents. Archive inactive records in accordance with the records retention schedule

Supports review, update, filing and distribution of controlled documents including SOP’s Standard test methods, protocols, and summary reports

Creates and maintains templates

Ensure controlled documents conform with applicable procedures and are maintained to latest revisions, reviews formats for consistency

Performs proof reading, word processing and filing to support QA, documentation, batch record and audit/inspection functions. Maintains deviation, CAPA. and change control data base/ records, document number issuance logs for controlled documents

Assist with internal audits

Archiving QA batch records

Sharp Corporation Conshohocken, PA Nov 15 – Oct 18

Position: Inventory / Material Planner

Work closely with XPReS teams to understand customer requirement, forecasts, order anomalies and /or patterns and understand /oversee material changes and transactions so as not to impact order due dates

Attend customer planning meetings/conference calls, review meeting minutes and email communications, forecasts, open sales order reports and/or planning data as necessary

Attend S&OP meetings to review order status and issues impacting packaging execution to meet sales order due dates

Attend daily scheduling/ operations meetings

Identify material and planning conflicts that could result in compromised customer due dates and communicate to appropriate teams

Work with scheduling group to review all open orders, material status, machine capacity and packaging timing to meet customer commitments

Communicate any issues /concerns to team

Follow through receipt to incoming inspection assuring all required documents are available to allow material release for packaging

Work with materials group to assure material movement between locations are completed as required and questionable inventory is cleaned up

Manage some account coordinators related duties in absence of AC as necessary to meet customer requirements

Identify opportunities for improvement and efficiencies in inventory management, capacity utilization and purchasing as applicable

Review and align the production schedules for assigned suppliers portfolio with internal planning and ensure established inventory levels are met

Works and partners cross functionally, primarily with Quality Assurance Production and Procurement

Responsible to review item master, product structure and product routing for accuracy and review/communicate to appropriate departments where maintenance of information may be required or advised to streamline purchasing, packaging, or other functions

Lead morning Huddle meeting with QA, production, procurement as well as department heads

Joule (Sharp Corporation) Conshohocken, PA Apr 15 – Nov 15

Position: Inventory / Material Planner

Work closely with XPReS teams to understand customer requirement, forecasts, order anomalies and /or patterns and understand /oversee material changes and transactions so as not to impact order due dates

Attend customer planning meetings/conference calls, review meeting minutes and email communications, forecasts, open sales order reports and/or planning data as necessary

Attend S&OP meetings to review order status and issues impacting packaging execution to meet sales order due dates

Attend daily scheduling/ operations meetings

Identify material and planning conflicts that could result in compromised customer due dates and communicate to appropriate teams

Work with scheduling group to review all open orders, material status, machine capacity and packaging timing to meet customer commitments

Follow through receipt to incoming inspection assuring all required documents are available to allow material release for packaging

Work with materials group to assure material movement between locations is completed as required and questionable inventory is cleaned up

Manage some account coordinators related duties in absence of AC as necessary to meet customer requirements

Identify opportunities for improvement and efficiencies in inventory management, capacity utilization and purchasing as applicable

Responsible to review item master, product structure and product routing for accuracy and review/communicate to appropriate departments where maintenance of information may be required or advised to streamline purchasing, packaging, or other functions

Lancaster Labs / GSK King of Prussia, PA Mar 11 – Dec 14

Position: Material Logistics Associate

Prepares and packages materials for shipment (International and domestic)

Demonstrates basic material handling/packaging/ warehouse equipment skills

Stocks and selects materials following First in First Out (FIFO) system

Maintains an approved level of inventory accuracy

Receives and quarantines incoming materials, reviews Purchase Orders and Packing Slips for each item

May be required to generate shipping labels and to schedule material delivery "pick up" by carriers

Establish and monitor Material Management programs and procedures to ensure compliance

Training of other employees

Receive, coordinate release and distribute GMP materials to support clinical production within Bio pharm R&D

Conduct material management operation in accordance with cGMP’s, GSK standards and dept. SOP’s

Support materials management functions while striving for 100% customer satisfaction

Comply with all safety related material handling procedures and equipment

Maintain the warehouse in a GMP state

Monitor and maintain warehouse equipment

Perform daily housekeeping for the warehouse and other associated areas.

Perform physical inventory and cycle counts

Process and maintain area paperwork/documentation in compliance with SOP’s

Assist with sampling duties when required

Perform duties related to material handling, inspection, process, distribution, maintenance and overall control to support MM activities for Biopharmaceutical R&D

Bulk drug transfers within GSK for production of reference standards

Internal and domestic shipments of bulk drug substances, reference standards and drug product under GMP requirements

Point of contact for all international shipments

Bionanomatrix/ Biological Research Sep 10 – Mar 11

Position: Quality Control Technician

Participate as a member of the Product Development team; execute projects in timely, diligent, safe, and professional manner, and contribute to the growth of the team and department

Responsible for understanding and performing lab tests on prototype, competitive, and upstream products, and materials

Document work procedures and test results accurately and completely in a laboratory notebook

Summarize test results, statistical analysis, conclusions, and recommendations in technical reports

Manually assemble prototype products

Assist in trial preparation, provide trial support to manufacturing, and test new or experimental trial products

Support corporate proprietary technology by documenting novel ideas

Provide competitive product analysis for product development and marketing

Develop and document new lab test methods to better predict and understand product performance in use

Investigate product quality problems and determine root cause and prevention action

Maintain adequate material and operating supplies

Maintain a clean workplace

GlaxoSmithKline R&D / Lab Support King of Prussia, PA Sep 09 - Sep 10

Position: Material Logistics Specialist

Procure, receive, sample, coordinate release and distribute GMP materials to support clinical production within Bio pharm R&D

Schedule and control GMP supply to meet production and to provide overall material expertise to support Bio pharm R&D

Management of Bio pharm bulk drug substance for use in safety assessment and phase II, III, IIII clinical supplies

Ship drug substance, reference standards and material supplies to support Bio pharm R&D assets

Maintain materials management documentation (logbooks, forms, raw materials files, records, and certificates

100% inspection of all incoming material used to support clinical production within Bio pharm R&D

Customer service

Interface with QA/QC regarding raw material sampling

Raw material sampling

GlaxoSmithKline SmithKline Phila, Pa Jun 07 - Sep 10

Position: Material Logistics Specialist

Procure, receive, sample, coordinate release and distribute GMP materials to support clinical production within Biopharma R&D

Schedule and control GMP supply to meet production and to provide overall material expertise to support Biopharma R&D

Management of Biopharma bulk drug substance for use in safety assessment and phase II, III, IIII clinical supplies

Ship drug substance, reference standards and material supplies to support Biopharma R&D assets

Maintain materials management documentation (logbooks, forms, raw materials files, records, and certificates

100% inspection of all incoming material used to support clinical production within Biopharma R&D

Customer service

Interface with QA/QC regarding raw material sampling

Bilcare Inc. Phoenixville, PA Dec 08 - Jun 09

Position: Quality Control Inspector

Determine proper in -process test standards and assure compliance to same

Perform accurate and timely inspection of incoming, in- process and finished materials and components according to established procedures.

Pull customer/Bilcare reserve samples

Verify documentation and inspect all shipments in support of distribution

Ensure testing is in adherence to current procedures and sampling plan

Ensure compliance with cGMP’s, SOP and CMDI during execution of shipping orders

Perform daily verification activities (temperature /humidity chart inspections, weight verifications on balances, etc.

Participates in investigations, deviations, discrepancies, technical problems, procedures, complaints and non- conformance of materials and processes

Assist in training employees in cGMP’s, Sop’s, MI, CDMI or quality issues as necessary

Change status of material, GMP areas, equipment, and utensils from quarantine to approve

Perform and document hourly inspections of production rooms

GlaxoSmithKline R&D King of Prussia, PA Jun 08 – Nov 08

Position: Material/Logistics Specialist

Procure, receive, sample, coordinate release and distribute GMP materials to support clinical production within Bio pharm R&D

Schedule and control GMP supply to meet production and to provide overall material expertise to support Biopharma R&D

Management of Biopharma bulk drug substance for use in safety assessment and phase II, III, IIII clinical supplies

Ship drug substance, reference standards and material supplies to support Biopharma R&D assets

Maintain materials management documentation (logbooks, forms, raw materials files, records and certificates

100% inspection of all incoming material used to support clinical production within Biopharma R&D

Customer service

Interface with QA/QC regarding raw material sampling

Raw material sampling

Catalent Pharmaceuticals Phila, Pa Feb 07 - May 08

Position: QA Inspector/Auditor (Bio Tech Cell Team)/ (Pouch Cell)

Documents hourly QA inspections on production packaging rooms as per both production protocol and Sop’s requirements as well as ensuring that the production protocol and GMP standards are being followed

Perform walk through audits of production floor and clean rooms to ensure cGMP are being followed

Reviews production room logbooks for cGMP compliance

Ensures that all inventory management system printed labels are correct against the information provided in the associated protocol for the production floor

Verify documentation for accuracy and completion in production rooms (components, drug verification etc.)

Reviews the batch record and any associated paperwork for any documentation errors made during the production packaging operation and again when the job is completed prior to submitting the batch record to document control

Reviews EMS system printouts for out of specification temperatures, humidity, and pressures

Knowledge/authorization to shut down production room if discrepancy issues are found

Responsible for proper handling and documentation of controlled substances. (Correctly document all steps on batch record.)

Follow batch record, Sop’s and cGMP’ s guidelines to ensure product specifications and tolerances are met

Verifies materials to and from production rooms and works with production to handle any discrepancies

Responsible for ensuring that Standard Operating Procedures are consistently followed, and that cGMP’s’ s are being observed while packaging operations

Participates in any investigation for a deviation involving batch record

Participates in customer audits when required and train new employees

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