Human Resources Quality Assurance

Stefanie Berryhill-Chain

Cell# 215-***-**** ******@*****.***

Summary: Professional Consultant with over 15 years of experience working in Finance, Government, Healthcare, Insurance, Education, Human Resources, Pharmaceutical, and Industrial Operations positions. Proficient in Microsoft Office – Access, Excel, Outlook, PowerPoint, Word, Windows, SharePoint, and Visio. Hands on experience in clinical studies, supply chain, human resources, transportation, production, pharmaceutical, and bio-technology systems. Core Competencies: Quality Management Systems Governmental Planning Education:

Project Resource Management Lean Six Sigma - White Belt 2027 (TBD) Business Administration B.S., Cedar Crest College, Allentown PA 2009 Business Management A.A.S., Lehigh Carbon Community College, Schnecksville PA Professional Background:

May 2024 – Present Harmony Biosciences, QMS Documentation Specialist (Meet Recruitment Ltd)

• Responsible for the Quality oversight of documentation activities at Harmony Biosciences in accordance with policies, procedures, industry guidance and health authority regulations.

• Work directly with the Quality Assurance team to ensure documentation archiving activities are executed according to Harmony Biosciences business procedures and system practices.

• Assist in the lifecycle of Quality Assurance (QA) documentation, which may include, creation, review, approve, revise, issue, supersede, and obsolete.

• Assist in the maintenance of Quality Procedural Documents (QPDs) such as Standard Operating Procedures (SOPs), policies, plans, manuals, templates, forms and other controlled documents stored in Veeva an electronic document management system (eDMS) and governed by the eDMS lifecycles.

Mar 2022 – Feb 2024 Eisai, Inc, Veeva Document Control Specialist

• Project Management of new and existing eDoc workflows utilized which includes accountability for system administration, validation, automation, operation, analytical, compliance, quality, facilities, pharmacology, and user support activities.

• Primary system administrator ensuring compliance of system with applicable regulations, company policies and procedures.

• Supported records management for Administration, Audit, Archive. Quality, Operations, Analytical, Stability, Supply Chain, Engineering, Validation, Facilities, Laboratory (Microbiology and Biochemistry), and Training.

• Manage and enhance the periodic review process for all controlled documents in eDoc and Veeva systems.

• Train new contractors and employees in procedural documents, period reviews,

• Experienced in MS Office, Adobe, WebEx, Documentum, LMS, CMMS, Trackwise, SharePoint, SAP, and LIMS. Nov 2020 – Mar 2022 Quotient Sciences, Senior GMP Document Manager/GDP Trainer

● Responsible for 100% full-detailed comprehensive review of GMP documents on behalf of Commercial Technical Validation Services and Manufacturing Groups within 72 hours of documentation.

● Managed all executed and archived documentation such as Executed Batch Records, Cleaning Validation Protocols, Level 1 and Level 2 Cleaning Records, OPS/TECH/VAL Training Forms, Deviations, CAPAs, Change Controls, Visual Inspections, Extended Test Protocols, and API/Detergent/Micro Analytical Samples.

● Trained new hires and interns on QS Manufacturing and Tech Validation records.

● Managed user access, passwords, trainings, and 3rd party registrations. Created and revised training quizzes and online modules.

● Experienced in eDoc, Veeva, LMS, ComplianceWire, SuccessFactors Learning, SAP, SharePoint, MS Office, and LIMS. May 2019 – Oct 2020 PCI Pharma Services, 3rd Shift Lead Quality Coordinator

• Reviewed and implemented SOPs, customer standards, procedures, and specifications for dissemination relative to batch records, Quality and Validation forms (IQ, OQ, PQ) and material specifications.

• Managed batch records, archives, accountability reports, investigations, deviations, change orders, and CAPAs and necessary documentation to customers to facilitate product production and release.

• Performed record reviews of audits and orders in process to ensure compliance with cGMP's and customer specifications. Jul 2018 – Apr 2019 Siegfried USA and Sharp Services, Sr QA Equipment Auditor (System One)

• Created Periodic Equipment Qualification Assessments evaluating Master Production Records by equipment, critical process parameter targets, corrective work orders, preventive maintenance, equipment calibrations, checkout sheets, P&ID drawings, Engineering projects, and validation/qualification status reviews.

• Reviewed and assessed change controls, deviations, batch log records, training records, minor equipment changes, audits, archives, etc.

• Responsible for cGMP compliance of assigned manufacturing operations, QMS maintenance for commissioning and qualification.

• Knowledge of ICH Q7, 21 CFR Part 11, US and EU FDA, USDA, EH&S, and cGMP compliances and regulations. Mar 2018 – Jul 2018 Catalent Pharma Solutions, Quality Systems Management Training Specialist

● External and internal audits, employee trainings, DEA/Production/Facility/Equipment forms, enable/disable users as a Systems Site Administrator in ComplianceWire, Trackwise, and Documentum.

● Responsible for managing COAs, COCs, SOPs, document retention, periodic reviews, and issuance and control logbooks.

● Coordinator in the Employee Engagement Team, i.e. Bring Your Kids to Work, Philly Treetop Quest, Aid for Friends, etc. May 2017 - Feb 2018 Sanofi Pasteur, Validation Data Pack Analyst 2 (AumVis PharmaTec)

• Managed and assisted over 600 employees in Industrial Operations with data pack assembly.

• Reviewed and assessed validation and qualification documentation of scale studies, filtrations, sanitizations, leachable and extractable studies, vendor memos, specifications, equipment alignments, line clearance forms, production runs, training verifications, audits, PI historian data, stability sample tests, work orders, change controls, and batch records. Jun 2015 – May 2017 Sanofi and Foster & Wheeler Engineering, Project Management Specialist

(Rangam Consultants and Universal Resources)

• Performed administrative and project management duties for Executives and VPs such as travel arrangements, scheduled meetings, ordered office supplies purchased heavy equipment, registered visitors, arranged video/audio conferences, electronic expense reports(concur), purchase orders, archives, audits, and administered multiple projects to meet 100% milestone.

• Reviewed, tracked, and uploaded over 1000 Sanofi, and Novartis technical and engineering SOPs, BOMs, URSs, CIPs, SIPs, MSDSs, change controls, deviations, CAPAs, blueprints, drawings, batch log records, cleaning records, validations, formulations, protocols, and deviations in SharePoint, i.e. Novartis, GSK, Eurofins, Amgen, Shire, Thermo Fisher Scientific, Pfizer, Merck, etc. Jan 2014 – May 2015 Johnson & Johnson, Document Control Analyst III (Dinalic LLC)

• Responsible for tactical activities related to all aspects of document control (creation, revision, approval, distribution, obsolete and retention).

• Exhibited Quality Assurance, Pharmaceutical Operations, and Computer Systems Validation Experience.

• Identified compliance gaps, provided resolution proposals and participated in Compliance Team Meetings.

• Knowledge of US and EU FDA, USDA, EH&S, and cGMP compliances and regulations. Computer Experiences:

Kenexa – Taleo – PeopleSoft

HRIS – SAP HR R3 – iCIMS

SAP ERP Finance – ORACLE Financial

NEXTS/ARIBA – SAP Concur

Citrix EMR – Med Access EMR

MIDAS Healthcare – COMET

SilkRoad ATS – OpenHire ATS Cognizant/Catalyst – GoldMine EClinical Works – WebPT Talent Network Samson – Markview – Bottomline Artiva - SSI - OnDemand BARRT - Navinet - Passport

Cerner - HMS - EDM

RevCyclePro

Microsoft – Intranet CRM – TEADS – Connect Vu – GUI DocCompliance – Quality eDoc Internet - WebEx – CRT ICOMS – OASYS – NPAC – E911 CDMS – EDMS – Planisware 6 CPT – Word Perfect 6.0 CNAM – LIDB – CLEC

ILEC Streamline

Labware LIMS– Trackwise R6 -

Documentum – Veeva – LMS -SAP

Community and Organization Affiliations:

● Volunteer Services at Senator Patrick Browne, Allentown PA

● African American Business Resource Group (AABRG)

● Society for Human Resource Management (SHRM)

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