Quality Assurance Customer Service

Monique Young

Roselle, NJ ***** 908-***-**** ad5wak@r.postjobfree.com

ADMINISTRATIVE SUPPORT PROFESSIONAL QUALITY SUPPORT ASSISTANT

Detail-oriented and highly organized Administrative & Quality Support Professional with expertise in quality assurance, compliance, and process improvement. Leverage proficiency in coordinating cross-departmental tasks, managing schedules,

and maintaining documentation to uphold quality standards. People-oriented, Mull tasked, quick learner, projects completed on time, detail-focused, ensure compliance of documents, decision maker, and good organizational skills.

CORE COMPETENCIES

Administrative Support Customer Service Quality Support Quality Assurance & Control Project Management

Cross-Departmental Collaboration Process Changes Process Improvements Complex Problem Solving

PROFESSIONAL EXPERIENCE

Siemens Healthineers, Flanders NJ QA Support III (Remote) 02/2019 – 09/2023

Checked the Training inbox and replied accordingly. Uploaded Training Documents and created Courses/Classes for each trainee. Provided customer service by phone/email to vendors across the world for part(s) requested by the engineers. Added Training Documents info to the log. Terminated training if an employee is no longer present. Reviewed Process Change / Engineering Change Summaries for the Engineers and signed off on them in the Signature Server or manually. Uploaded pFMEA/PRT Docs. for engineering dept. Maintained and filed documents according to internal guidelines. Scanned QN tags and uploaded them into the SAP System. Troubleshoot issues with inspection plans/QIRs.

●Set up PCRB meetings for Process Changes, Quality Systems, Engineering Changes, and TMDs under GMP and regulatory guidelines.

●Sent out the agenda for the day to different departments, ensuring they are aware of what’s being presented.

●Transcribed notes from PCRB meetings and uploaded minutes into Documentum/D2; ensured the presenter had the correct version of the document for CIA, Change plan, and Summary.

●Provided change numbers in PCRB Meetings for Process Changes and validation document numbers for protocol projects.

●Ensured documents were complete and in order by checking the page numbers, signatures, and no cut-off of words. ● Scanned and uploaded Process Change, Quality System, Engineering Changes, and Validation documents into Documentum / D2 per internal guidelines.

●Maintained PCRB and Validation log of scanned documents, to have accountability for each project and product being worked on.

●Reconciled the PCRB and Validation log and folders in Documentum / D2 to correspond with the logs.

●Worked cross-functionally with the Document Control Team, scanning, and uploading (Summaries and Work Instruction documents) for Process Change and Engineering Changes; time spent 10%.

●Created inspection plans and QIRs for the engineers to receive parts for incoming inspection in the warehouse through the SAP System.

●Approved QIRs through the Team Center for the engineers to order parts from multiple vendors.

Infotree Agency, MI Siemens Healthineers, Flanders NJ QA Support III 3/2018-2/2019

●Setting up PCRB meeting for Process Changes, Quality System, Engineering Changes and TMD’s under GMP and regulatory guidelines

●Sending out the agenda for the day to different departments, ensuring their aware of what’s being presented.

●Transcribing notes from PCRB meetings and upload minutes into Documentum; making sure the presenter has the correct version of the document for CIA, Change plan and Summary.

●Providing change numbers in PCRB Meeting for Process Changes and validation document numbers for protocol projects

●Ensuring documents are complete and in order by checking the pages numbers and signatures.

●Scanning and uploading Process Change, Quality System, Engineering Changes and Validation documents into Documentum per internal guidelines

●Maintaining PCRB and Validation log of scanned documents, to have accountability of each project and product being worked on

●Reconciling the PCRB and Validation log and folders in Documentum to correspond with the logs

● Uploading pFMEA/PRT Docs. for engineering dept.

●Working cross functionally with the Document Control Team, scanning and uploading (Summaries and Work Instruction documents) for Process Change and Engineering Changes; Time spent 10%

●Maintaining and File Documents according to internal guidelines

●Scanned QN tags and uploading into the SAP System

TechData Agency, PA Celgene, Summit NJ Document Coordinator (Remote-2 days) 11/2016 – 09/2017

Clinical queries to Celgene-sponsored clinical trials are copied to the Clinical Operations SAE Alert mailbox. Worked 10 hours OT (Mandatory) when advised; worked from home 2x per week. Performed follow-up for Special situations without adverse events created a follow-up query in the Common Communication Module of the Celgene pharmacovigilance database with all the necessary documents (e.g., cover letter, Adverse Drug Experience Report Form, and other applicable forms) and sent the following up letter package to the prescriber or other health care professional.

●Initiated Fast Track Follow-up measures if source documents received are illegible and/or if the correct number of pages was not received.

●Created or updated a previously created Fast Track Follow-up record to document receipt of new information.

●Performed non-AE follow-up measures for all non-AE scenarios including but not limited to drug discontinuation, dosage reduction, hospitalization only, surgery only, and transfusion-only cases (see WP-G- 501, Receipt and Work Aid for Identification of AE (valid ICSR) vs. non-AE (non-valid ICSR).

●Performed the following due diligence activities in the Common Communication Module:

●Send the follow-up letters/queries for cases that need initial or subsequent follow-up and/or cases that need another manufacturer suspect product letter.

Sunrise System Agency, NJ (TEVA Pharm., Monmouth Junction, NJ) Administra1ve Assistant 03/2016 – 11/2016

Predominantly focused on document archiving of different teams (Analytical Chemistry, Engineering, Formulation

Development, QA, QC, Process Development, R&D. Worked with Iron Mountain to archive and retrieve boxes; software (TRIM Syst.). Coordinated and collected personnel information (job description, CVs, etc.).

●Backed up for Sr. Office Administrator and Sr. Assistant (front desk, order supplies, setup meetings).

●Assisted with other Depts. when needed (scanning, copies, emails).

●Worked with different applications (Teva Doc, TevaLMS, Compliance Wire, Stadium, Share Drive, SharePoint, PowerPoint, Adobe Acrobat, Microsoft Visio, SnagIt; Strong MS Office skills (Excel, Word, Outlook, Access).

ALLSourcePPS Temp Agency, CA (Merck Pharm., Rahway, NJ) Senior Clerk III 08/2015 – 12/2015

Customer Service (Phone calls/emails). Maintained spreadsheet (GS operation team site, Records Management). Entered data & archived cases in (MIDAS CDS). Electronically filing, filing, scan, fax, copy, print cases from (Argus, SPARC, Oracle, VAULT, Java, MARRS, and IBM Cognos). Excel, PowerPoint, Microsoft Office, and Word; worked independently. Continued training of SOP’s guidelines.

●Project (pulled 216 boxes back from Iron Mountain to locate 2,008 Adverse Event files of a Merck product through Records Mgmt.) Lin boxes up to 70lbs; stored boxes in warehouse/office; transport files.

ALLSourcePPS Temp Agency, CA (Merck Pharm., Springfield & Rahway, NJ) Senior Clerk III 03/2013 – 04/2014

Operated department independently of archiving medical records and misc. docs. Faxed, scanned, mailed, copied, filed, ordered supplies, and sorted GPV documents. Daily emails of requested archived documents for audits and miscellaneous departments. Warehouse had approx. 1.2K boxes to archive.

●Scanned Quintile & Nuvaring Docs. into the SAP Syst. and archive them for the years 2010 & 2011.

●Data entry of spreadsheets of archived boxes for Records Mgmt. and send boxes to offsite storage; (work from home 1-2 days a week).

●Worked w/ Records Management (retrieval/return documents to Iron Mountain).

Schering Plough/Merck Pharm., Springfield, NJ Senior File Room Clerk 01/2006 – 12/2011

Secured file room from 8:30am to 5:00pm. Maintained GPV logbook of signatures; inventory of both file rooms. Pulled /put back files for Dr’s., Specialist, Nurses in the file room. Daily emails of requests of files for the Case Processing Team & FDA Audit. Provided support to the “Report Generation Team”. Copied & pasted AD-HOC Request tracking sheets to 2006 binder spreadsheets: Data entry of AD-HOC information onto tracking spreadsheet.

●Researched missing files by checking the out cards monthly. Continuous training under GPS & SOP guidelines.

●Distributed Batch Reports to Team Leaders, Dr’s., Specialist, Nurses and Contractual Partners.

●Assisted other teams (Allergy/Respiratory, Gynecology, Hematology, Oncology and Dermatology).

●Crossed trained w/ other depts., Train team members of various projects.

●Archived boxes under the retention schedule & cost center # e.g., (Quintiles, AMPS).

●Completed metrics & spreadsheets; Work w/ Records Mgmt. to send/retrieve archived boxes to Iron Mountain: Send AE files to Clin-Doc.

●Archived, copied, data entry, filed, send/receive faxes and mailing (DHL / FedEx) of documents for GPV Operations or Triage.

Kelly Serv. Agency, NJ Schering-Plough Pharm., Kenilworth, NJ Librarian Clerk 2/2005 –1/2006

●Assisted w/ preparing spreadsheets / pin-coded controlled copies of procedures for distribution to the lab areas; customer service (front desk).

●copied, faxed, emailed, check mail, made labels, filed, and archived (PSID, Mo, Ric, CA, Protocols, Stability Records, and Global Level III Doc.).

● Trained for Zyimage Scanning.

Winston Staffing Agency, E. Rutherford, NJ. Morgan Stanley, Jersey City Tui1on Reimb./ HR Rep 12/2003–12/2005

●Handled the Tuition Dept. independently by processing (tuition forms, calculate reimbursement and forward information into acct’s payable syst.).

●Assisted w/ HR Dept. by (updating employee information).

Health Administrators Inc., Parsippany/Fairfield NJ Data Entry / Claims Examiner 10/1997-3/2001

●Process Claims Forms & Medical Claims Forms for HIP, Blue Cross etc.

●In the process of training for Claims Examiner

●Knowledge of Billing & Coding (CPT4 & ICD9)

Education & Credentials

●Academy of Allied Health & Science, Newark, NJ, Clinical Medical Assistant/Administrative, Med Term., Insurance, billing, EHR. (Certificate) 9/2014-3/2015

●Alpha-Train Institute, Union, NJ, Computerized Office Specialist (Certificate) 3/1996 – 9/1997

●Abraham Clark High School, Roselle NJ, Business Administration (Diploma) 9/1989 - 6/1991

●Roselle Catholic High School, Roselle NJ, Business Administration (Transfer) 9/1987 – 6/1989

(References furnished upon request)

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