Experience

Rhodes Technologies Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Contract Specialist / Document Coordinator (Part-Time)

  • Jun 2017 - Present

  • Initiate, draft, and revise legal agreements through finalization to support pharmaceutical company in-house attorneys• Interface with vendors and internal business partners to establish Confidential Disclosure Agreements, Statements of Work, and Master Supply & Clinical Lab Agreements• Review documents with legal department to ensure document details are accurate and resolve any issues with vendors• Ensure status of company covered persons or attorney general covered persons were defined • Confirm fully executed documents are received prior to commencement of contracted work• Coordinate track and review, initiation, drafting and completion of expiring contracts due for renewal or extension• Track and generate departmental documentation metrics



TechTrueUp

• United States
• Human Resources Services
• 1 - 100 Employee

• QA Specialist (Contractor)

  • Aug 2016 - Jan 2017

  • Perform Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current (cGMP), Good Distribution Practices (GDP) and other applicable regulations• Review and approve of cGMP processes, procedures, documents and records, including Non-Conformance, Corrective Action/Preventative Actions (CAPA), Document Control records and Validations• Ensure that changes, and deviations from established procedures, that could potentially impact product quality are assessed, investigated and documented according to procedures.• Provide on the floor oversight to ensure facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations• Supported Continual Improvement initiatives, programs and projects



ProPharma

• United States
• Business Consulting and Services
• 700 & Above Employee

• QA Compliance Specialist (Contractor)

  • Nov 2014 - Jul 2015

  • Perform investigations and root cause analysis for Facilities Department into non-conforming events in compliance with cGMP• Review and revise SOPs, Work Instructions and other peripheral documents as appropriate• Act as a liaison between the Facilities Department and other onsite departments to define and address issues of non-compliance • Provide support, information, and assistance to other Facilities personnel with the initiation, review, submission, and follow-up of documents such as change controls, investigations, impact statements and corrective action plans• Perform review of Facilities preventative maintenance records and corrective work orders to assess for compliance with established quality standards, policies and procedures• Facilitate review and revision of Facilities Department related SOP’s, plans, and policies.



ALKU Technologies

• Process Validation/Technical Writer Consultant

  • Nov 2013 - Jan 2014

  •Authored summary documentation necessary to close long term outstanding complex process deviation for medical device company initiated during Phase II clinical trial •Generated manufacturing process SOP revisions to meet new requirements•Audited Training Records of Manufacturing Department personnel, including compliance statistics and gap analysis against newly restructured requirements to prepare for upcoming Phase III clinical trial launch •Authored summary documentation necessary to close long term outstanding complex process deviation for medical device company initiated during Phase II clinical trial •Generated manufacturing process SOP revisions to meet new requirements•Audited Training Records of Manufacturing Department personnel, including compliance statistics and gap analysis against newly restructured requirements to prepare for upcoming Phase III clinical trial launch



Oxford Global Resources

• Quality Assurance SME Consultant

  • May 2013 - Jul 2013

  •Researched and reviewed CAPA findings and Gap Analyses for adequacy in addressing FDA findings and to further assess depth of known QSM issues of large medical device company•Authored and executed Global QA Legacy Review protocols against FDA audit findings and resultant CAPAs•Generated protocol sampling plans and rationale in support of CAPA Review output metrics •Researched and reviewed CAPA findings and Gap Analyses for adequacy in addressing FDA findings and to further assess depth of known QSM issues of large medical device company•Authored and executed Global QA Legacy Review protocols against FDA audit findings and resultant CAPAs•Generated protocol sampling plans and rationale in support of CAPA Review output metrics



Boston Scientific

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Quality Assurance Analyst II

  • Sep 2010 - Nov 2012

  •Generated and presented site metrics for Core 5, Management Review & CAPA Review Board •Coordinator, contributor and presenter for site-wide Management Review & CAPA Review in compliance with CFR 820, 210 and 211, EN ISO 13485:2003, EN ISO 11135-1:2007•Generate metrics to support site for Ops QMR and Deep Dive drill downs•Site eCAPA Coordinator and eCAPA Analytics SME/Power User•Collaborated with team to drive CAPA phase cycles for effective and timely completion, maintaining tracking and trending of essential CAPA data (ie. FMEA, Root Cause, etc)•Apply LBP and 5S to lean processes and practices within areas of responsibility•Back room support for internal/external site audits•Review approval & release of SFUs •Write/review/revise SOPs, Work Instructions and other peripheral documents as appropriate•As QA Technician IV (Temp): NCE Coordinator; SOP revision, in-line process checks (sterilisation facility), BI testing, SPR (batch record) documentation, review, approval, and product shipment release to distribution centre



Independent Contractor

• QA Validation Documentation Specialist,

  • 2007 - 2008

  • Reviewed, validated and constructed Equipment Turnover Package documentation libraries meeting client expectations in a timely manner and strict adherence to GMP practices • Resolve documentation non-conformance issues • Wrote, edited, and executed Quality Assurance Test Scripts to support launch of new proprietary software converting SOPs for electronic notebook application in cGxP environments • Reviewed, validated and constructed Equipment Turnover Package documentation libraries meeting client expectations in a timely manner and strict adherence to GMP practices • Resolve documentation non-conformance issues • Wrote, edited, and executed Quality Assurance Test Scripts to support launch of new proprietary software converting SOPs for electronic notebook application in cGxP environments



Manpower Professional

• QA Documentation Specialist (Temp); Office Manager, Right Management Pfizer Career Centre (Temp)

  • 2006 - 2007

  • Managed client databases and developed and maintained tracking systems• Executed an Outreach program, resulting in increased client base and client retention • Designed, authored, edited and produced Monthly Newsletters and Events Calendars• Set up and promoted networking events• Prepared coursework modules for classroom seminars• QA of documentation conversion from hard copy USAF manuals to online training system • Wrote and designed interactive CBT (computer based training) training modules for USAF



Amgen

• Pharmaceutical Manufacturing Associate I, Inoculum Prep Team

  • 2003 - 2005

  • Performed lab instrument and cryostorage unit, monitoring, maintenance, and troubleshooting (i.e. BGA, YSI, Fiske Osmometer, Cedex, Sorvall, Mettler-Toledo Balances, Bell Magnetic Stirrers, Thermo Incubators)• Negotiated instrument service contracts and tracked maintenance and calibration schedule• Conducted P & ID's walk-downs of plant systems and executed Validation Protocols of Start-up lab equipment (MQ, IQ, OQ, PQ)• Executed batch record documentation, calculations and tracking (WERUM, Pi Historian, Finite Scheduling, JDE/ERP)• Performed batch record review and revision, and assisted in writing Change Controls, N/Cs and CAPAs • Consulted, drafted and assisted related departments with SOPs for equipment use, cell culture manipulations, and the safe handling, control, transport and use of reagents, solutions and associated materials• Initiated Cell Thaws, subsequent open/closed passages (LFH and RS2/Climet EM equipment), and maintained cell lines (CHO)• Developed solutions for spinner scale-up process in cooperation with Process Development and Quality Assurance• Executed Shakedown and FDA Conformance lots for start-up lab well within corporate timeline goal • Executed bioreactor inoculation and sampling (Delta V /Siemens Control System)• Performed in-process analyses against parameters--upstream and downstream (glucose/lactate, pH, O2/CO2, Osmolality, Cell Count--Manual/Automated, Viability, Microscopy)



Graafin Enterprises

• Owner/Operator

  • 1999 - 2003

  • Established independent consulting service for spa/salon industry serving new and established businesses in need of technical, administrative, and/or structural modernisation• Drafted and negotiated contractual agreements and salon design plans on for salon owners• Specified and oversaw computer installation, and performed computer software set-up and support• Provided sales, technical, and industry software training for employees• Wrote employee manuals and established business guidelines for owners• Secured cost effective benefits for employees which increased employee retention• Provided Human Resources support, advertising and marketing plans, and employee recruitment



Path Lab, Inc.

• Microbiology Aide

  • 1998 - 1998

  • Accessioned, reviewed and tracked received samples and documentation for subsequent testing including Chain-of-Custody • Ensured accurate urinalyses and fecal analyses, using both automated bench-top equipment and via microscopic exam• Performed Quick-Strep diagnostic analyses• Plated samples utilising corresponding media for desired testing• Conducted sample handling and aliquotting using GLP• Maintained result entry database and computer based dispatch for authorized medical informational release



All Pets Veterinary Hospital

• Veterinary Technician

  • 1986 - 1988

  • Member of close working technical team to Dr. J. Gaines (DVM), in small animal, avian and exotics practice• Surgical assistant, including anaesthesia • In-patient treatment nurse and radiographer • Performed lab analyses including, but not limited to, stains, haematology, and microscopy • Provided support, education and home instructions to pet owners, and trained new staff members • Member of close working technical team to Dr. J. Gaines (DVM), in small animal, avian and exotics practice• Surgical assistant, including anaesthesia • In-patient treatment nurse and radiographer • Performed lab analyses including, but not limited to, stains, haematology, and microscopy • Provided support, education and home instructions to pet owners, and trained new staff members



California Animal Hospital

• Veterinary Technician

  • 1981 - 1981

  • Back office technician for cardiac specialist Dr. Stephen Ettinger (DVM)• Performed EKG tests and monitoring• Delivered medications and treatments required for cardiac patients in small animal specialty practice • Provided support, education and home instructions to pet owners • Back office technician for cardiac specialist Dr. Stephen Ettinger (DVM)• Performed EKG tests and monitoring• Delivered medications and treatments required for cardiac patients in small animal specialty practice • Provided support, education and home instructions to pet owners



Emergency Pet Clinic

• Veterinary Technician

  • 1979 - 1980

  • Critical care technician for Dr. B. Silverman (DVM) in predominantly small animal emergency practice• Performed initial emergency room assessments and triage measures • Assisted in broad range, trauma, and surgical procedures • Conducted diagnostic tests using EKGs, X-ray, standard bench-top lab analyses and microscopy • Critical care technician for Dr. B. Silverman (DVM) in predominantly small animal emergency practice• Performed initial emergency room assessments and triage measures • Assisted in broad range, trauma, and surgical procedures • Conducted diagnostic tests using EKGs, X-ray, standard bench-top lab analyses and microscopy