Associate Sr Consultant Qa resume example with 20+ years of experience
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Experienced Senior pharmaceutical Quality Assurance Consultant with 20 years of experience managing all aspects of Global Product Complaints. Deep understanding of both regulatory and internal expectations to drive a compliance mindset across the organization.
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Peace Health – Burlington, WA,
Led Global Product Complaint (PC) Management including the following:
- System owner for the global product complaint management database. My responsibilities included collaboration with my IT counterpart to determine and approve business/system requirements. Identify Beta testers and ensure any non-working functionality was corrected prior to system release. Approved all business documentation required for system release. Coordinated with Training coordinator to design and deliver training guide and hands on training
- System owner for global metrics reporting tool. My responsibilities included design/review/approval of requirements for standard reports that could be used by manufacturing sites and marketing affiliates, as well as the ability to build ad hoc reports to be used at the global level
- Business Process Owner of global product complaint standard. This standard provided the high level regulatory agency requirements required for PC management at the manufacturing sites and marketing sites. Coordinated with the Training coordinator to develop and deliver applicable training/assessments
- Designed global product complaint metrics to be delivered to senior management as a high level snapshot of product complaints.
- SME for FDA product complaint metrics pilot
- Business process owner for product complaint improvement related 6 sigma projects
- Worked closely with out-sourced and then in-house call centers. Lilly used an out-sourced call center for a period of time and I shared some Q oversight responsibility to that facility. Reviewed procedures, patient interactions and ways to streamline complaint intake. When the call center was moved in-house, I was the complaint representative member of the team to review procedures. I was responsible for design and delivery of complaint database training to the call center representatives. I provided Q oversight in the periodic meetings during the discussion of deviations
- Supported agency inspections FDA, EMA, MOH, etc, by providing product complaint data and speaking to the global product complaint standard
- Led business process to determine what and how to merge product complaint data from a business alliance into the Lilly global product complaint database
- Supported product complaint regional centers and local mfg and marketing affiliates by leading monthly product complaint meetings to share best practices, metrics, and information on upcoming complaint database releases
- Liaised with Pharmacovigilance organization/IT to build a link between the two databases. This would allow us to look at key points where adverse events could be related to a quality issue in manufacturing
- Hosted/led Pharma company discussion groups
- Co-chaired Pharma company product complaint conferences
Eli Lilly And Company – City, STATE,
I was hired at Lilly as a Consumer Technical Services representative. The role was a product complaint coordinator for the US. I was one of two Pharmacists that had responsibility for reviewing product complaints from the US call center, determining the need for return of product, assessing physical aspects of returned product, sending to the manufacturing/packaging site for investigation, and responding to the patient. Responsible for annual controlled substance review of returned product complaint samples. Periodically, I would travel to the US call center to review complaint management process and work with the call center management to improve complaint intake process. I managed our third party manufacturers, reviewed quality agreements and provided complaint data. Early 2002 I was promoted to Global Complaint Consultant (Associate Sr Consultant QA). There was a period of time where I performed the role above and the Global Complaint Consultant role.
Hook's Drugs – City, STATE,
Registered Pharmacist 1980 until 1992: I started as an Assistant Manager and gained management experience as I moved and worked at three different stores. In 1985, I was promoted to Store Manager and successfully managed two different stores in the Indianapolis area. Responsibilities included the following:
- Accurate filling of prescriptions and patient and health care practitioner consultations
- Maintaining pharmacy inventory
All store functionality:
- Accountable for ensuring appropriate staffing
- Maintaining appropriate store inventory including warehouse orders and outside vendor merchandise
From 1992 to 1995, I was the Assistant pharmaceutical buyer. My responsibilities included:
- Determining amounts of drug product to be ordered from direct Pharma companies or from wholesaler only companies and maintaining a 4-6 week warehouse inventory.
- Consulting with Primary Buyer to determine best time to purchase pharmaceuticals
- Met with Pharma company and wholesaler representatives to negotiate which drugs to purchase
- Oversaw the product returns to Pharma companies or wholesalers ensuring compliance standards were followed at all times
- Responsible for re-packaging process from bulk packaging. Filed FDA registration forms and designed bottle label/information in accordance with applicable regulations.
Butler University - Indianapolis, IN,
I have been involved with Special Olympics (in Johnson County, Indiana) for the last 15 years. I have been on the county management team for ten years and served as the treasurer overseeing the annual budget. I am currently serving as the County Coordinator with the overall accountability for the program.
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Resume Overview
School Attended
- Butler University
Job Titles Held:
- Associate Sr. Consultant QA
- Product Complaint Coordinator
- Pharmacist
Degrees
- Bachelor of Science
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