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Drug Supply Coordinator/Supervisor Resume Example

Resume Score: 90%

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DRUG SUPPLY COORDINATOR/SUPERVISOR
Summary

5 years of management experience with 3 years in mechanical engineering and 2 years in pharmaceutical industry. Results-driven, skilled supervisor focused on achieving success and increased productivity through improvements in operations, quality, safety and administration

Highlights
  • Skilled and trained in TrackWise (PSQRS), Cognos and ERP systems monitoring such as POMS (Product Order Management Systems)
  • Developed and Reviewed Standard Operating Procedures (SOPs), Validation Master Plans (VMPs) and Validation Summary Reports (VSRs)
  • Conducted investigations and monitored progress for any process gaps related to packaging as per Research Commercialization and Quality (RCQ) standards
  • Familiar with the process and development of the batch record in GDP fashion
  • Familiar with FDA regulated environment with good understanding of cGMP guidelines, and 21 CFR Part 11 and 211
  • Processed change control on the issued staged materials and updated batch records by working with QA and project management
Accomplishments
  • Planned, directed, coordinated and assigned manpower to efficiently meet production requirements.
  • Supervised second shift operations and more than 7 production and assembly line staff.
  • 98% Quality deliverance rate.
  • 100% SOP, deviation memos and CAPA deadlines.
  • 96 % RFT (right first time) metrics.
  • Validation Engineering Course and Training successfully completed (October–December 2012).
  • HIPPA Certified (2011-Present).
  • Registered Pharmacy Technician (2009-2011).


Experience
Drug Supply Coordinator/Supervisor
December 2014
Merck & Co/PRA - West Point, PA
  • Check global clinical supply inventory for both IVRS and traditional studies via tracking of specific milestone dates and adjusting drug distribution plan accordingly
  • Resolve issues involving Operations, Planning and Quality
  • Lead Subject Matter Expert (SME) for Formal Stability Studies (FSS)
  • Manage clinical supply complaints received from investigative sites and/or subsidiaries, address supply replacement requests.
  • Manage a team of 14 technicians and assign/schedule their daily tasks
  • Monitor expiry dating for clinical study supplies
  • Review Notice of Events (NOE), initiate investigation and CAPA (if necessary) to improve process flow
  • Initiate, write-up deviation for any potential product impact
  • Interact with other departments, as needed, to resolve any issues involving clinical supply inventory and distribution
  • Resolve and document urgent/critical unblinded and pharmacy related issues and investigate trends.
  • Provide input to refine the clinical supplies process in alignment with stakeholder needs and in compliance with systems and strategies
  • Coordinate development and maintenance of learning plans and assuring consistency across RCQ
  • Contribute to ensuring optimum utilization of resources and compliance with project deadlines
  • Review monitoring visit reports as designated (initiation, periodic & close-out)
  • Identify documents and escalates major/critical issues to the clinical trial team
  • Provide updates to clinical trial team on pharmacy-related and compliance issues in a blinded fashion
  • Ensure that all tasks meet sponsor and PRA expectations, and are delivered in accordance with the contract, trial protocol and applicable SOPs
  • Interpret packaging specification to determine clinical supply needs for packaging and labeling of clinical supplies
  • Manage global inventory management of bulk clinical supply chain investigational materials, including bulk drug product, primary packaged drug product, clinical packaged supplies (finished goods) and package components
  • Prepare required documentation and assist internal and external stakeholders to facilitate activities for the import and export of clinical supplies, as required.
Project Coordinator/Supervisor
October 2013 to November 2014
Merck & Co/Insync - West Point, PA
  • Assisted in determination of project requirements and preliminary schedules
  • Established project work plan and calendar or schedules; monitor, reviews, and evaluate progress
  • Track the progress and quality of work being performed by the technicians
  • Use project scheduling and control tools to monitor projects plans, work hours and expenditures
  • Communicate ideas for improving company processes with a positive and constructive attitude, and developed this attitude within technician
  • Assign daily projects and tasks to technicians and ensure the production meets the deadlines
  • Reviewed GMP batch records, initiate investigation and write investigation report
  • Reviewed clinical complaints, initiate investigation and CAPA (if necessary) to improve process flow
  • Finish periodic revision of SOPs and write deviation memo for the procedures already in place until next revision is in effect
  • Process different nature of Clinical Packaging Orders (CPOs) with different clinical techniques in order to deliver RCQ dates on time
Lab Supervisor
May 2013 to September 2013
Xerimis Pharmaceuticals - Columbia, NJ

A Clinical packaging firm that mostly serves pharmaceuticals, bio-technology and clinical research organizations.

  • Assisted with clinical protocol development, interpretation and implementation of packaging plan generation.
  • Coordinated related activities with clinical manufacturers, analytical laboratories and IVR responses
  • Provided support to clinical trials and packaging qualification activities prior to introduction of any new or change in processes
  • Ensured cGMP and regulatory compliance are met by following all the written and signed SOPs
  • Read all the batch records and ensure bill of materials are up to date
  • Ensured that change control procedures are followed working with QA and Regulatory to implement changes
  • Involved in process management and change control procedures of different manufacturers depending on the pharmaceuticals drugs that are staged into the lab and materials rejects.
  • Worked with project management and QA to ensure staging material's batch record and bill of materials are up to date with the newly issued change control Collaborated with cross-functional teams (i.e.QA/QC, Maintenance, Regulatory, etc.) in pre-commercial and commercial activities
  • Provided support in the assessment, development, and implementation of solutions for complex problems related to packaging or packaging systems
Lab Manager/Research Assistant
June 2009 to July 2012
University of South Carolina - Columbia, SC

An application of health monitoring systems in the prediction and prevention of the detectable component failures in the main rotor and tail rotor articles on the US Army Apache helicopter

  • Contributed in the decrease in maintenance costs, increased flight safety and enhanced mission capabilities of the rotorcraft fleets by testing seeded and naturally fault component
  • Investigated new sensor technologies and signal processing techniques by analyzing data after helping install and monitor new sensors
  • Performed accelerated-life fatigue tests and integrated advanced engineering, maintenance, and information technologies
  • Discovered operational characteristics by discovering unscheduled maintenance and maintenance workload
  • Developed and applied new diagnostic algorithms Assist with two different hydraulics system containing pressure of 500 psi and 1000 psi each to maintain balance in tail rotor and main rotor swashplate of an apache AH 64D.
Pharmacy Service Associate
June 2008 to May 2009
CVS Pharmacy - Columbia, SC

Retail Pharmacy that required extensive knowledge of drug related, prescription (new/refill and transfer prescriptions), health and insurance information with great customer service while maintaining CVS standards

  • Performed all prescription pick-up procedures, in adherence of CVS policy and procedures; Complete Prescription Pick-Up Log, and validate customer address
  • Maintained prescription prioritization throughout prescription processing
  • Resolved Third Party rejections and complete any manual claim forms Retrieved and file prescriptions appropriately according to State and Federal Law
  • Participated in all required store operational meetings Interacted with patients to allow them to become more knowledgeable about their medications
  • Ensured the doctor and insurance company were aware of the prescription being filled Accessed, input and retrieved information to/from the computer.
Sales Associate
January 2007 to January 2008
Milan Jewelers - Florence, SC
  • Developed retail sales skills by gaining knowledge on different jewelry products and designs that can help assist customers in selection of the fine jewelry purchases.
  • Successfully sold over $400,000 of a wide range of jewelry and accessories.
  • Satisfied customer needs by matching customer requirements to product specifications.
  • Maintained monthly sales goals and profit margins of the company.
Education
Bachelor of Science : Biomedical Engineering, May 5, 2012University of South Carolina - Columbia, SC, United StatesGPA: Academic Honors and Awards LIFE Scholarship recipient (2007-2011), President's List (2009), Dean's List (2009), Capstone Scholar (2008), Sam Walton "Wal-Mart" Scholarship recipient (2008)

Biomedical Engineering Academic Honors and Awards:

  • LIFE Scholarship recipient (2007-2011)
  • President's List (2009)
  • Dean's List (2009)
  • Capstone Scholar (2008)
  • Sam Walton "Wal-Mart" Scholarship recipient (2008)
Project/Research Experience

Senior Design (2011-2012) 

  • Collaborated with Great Lakes Neurotechnologies to design an iPhone application for Parkinson's disease patient that can create mobility to patients and help connect with their doctors easier and faster

Biomedical Manufacturing Design (2012) 

  • Developed a new protocol for testing maximal tremor detection for the Parkinson's disease patient and recorded all the movement in different directions
  • Utilized Kinesia Homeview instrument as a constant tremor-monitoring device to perform directional detecting test

Tissue Engineering (2011) 

  • Introduced heart valve replacement technique of any sheer stressed, shapeless or poor blood flow through a valve by doing detailed research on Medtronic freestyle aortic root bioprosthesis
  • Worked on tailoring heart valve which proved that bioprosthesis may also be available in different sizes and diameters depending on patient's natural valve
  • Introduced future improvements that prevents open heart surgery by inserting stented heart valve through femoral artery, which may cause minimal invasive surgery

Biomaterials (2011) 

  • Performed compatibility of different biomaterials for ball and socket connection of hip resurfacing
  • Developed different techniques to help retain metal and ceramics longer than usual
  • Operated Lab Master machines to perform material stress/strain tests
Language and Skills
  • Fluent in Hindi, Gujarati & English
  • Sales and manufacturing experience
  • Exceptional communication skills
  • Fast learner, persistent, and highly motivated

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Resume Overview

Companies Worked For:

  • Merck & Co/PRA
  • Merck & Co/Insync
  • Xerimis Pharmaceuticals
  • University of South Carolina
  • CVS Pharmacy
  • Milan Jewelers

School Attended

  • University of South Carolina

Job Titles Held:

  • Drug Supply Coordinator/Supervisor
  • Project Coordinator/Supervisor
  • Lab Supervisor
  • Lab Manager/Research Assistant
  • Pharmacy Service Associate
  • Sales Associate

Degrees

  • Bachelor of Science : Biomedical Engineering , May 5, 2012

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