Robyn Westover
Fallston,MD
Summary
Proven Quality Assurance professional with a robust background in regulatory compliance and product quality improvement at Ferring Pharmaceuticals. Expert in Post Market Product Complaint Management and possesses keen attention to detail, significantly enhancing operational efficiency. Demonstrated success in leading quality system enhancements and driving continuous improvement initiatives.
Overview
19
19
years of professional experience
Work History
Associate Manager, Quality Assurance
Ferring Pharmaceuticals
07.2016 - Current
- Manage Product Quality Complaint process through Trackwise to ensure proper documentation of drug product complaints, medical device complaints, and adverse events associated with product complaints including case data entry.
- Perform product complaint sample evaluation
- Identify reportable events (Field Alert/Recall) and report to FDA in accordance with regulations associated with Complaint Handling and Medical Device Reporting
- Conduct training for product complaint intake for Third Party Patient Support Vendors
- Responsible for providing complaint metrics
- Work closely with 3PL Call Center Management to identify gaps in Quality Assurance/Compliance and implement corrective actions as needed
- Compile weekly and monthly reconciliation of data exchange between product complaints, drug safety and third party call center
- SME for product complaints for all audits and inspections
- Perform self inspections for other functional areas
Specialist, Quality Assurance
Ferring Pharmaceuticals
10.2013 - 07.2016
- Maintenance and administration of Standard Operating Procedure (SOP) System by processing and routing procedures within system
- Monitors and tracks status of SOPs process
- Administration of SOP training for FPI employees
- Maintenance of training metrics and records
- Assist in preparation of local SOPs to ensure compliance to GMPs, local requirements and corporate standards
- Administration of GMP training program, which may include working with vendor
- Assist in performing quality internal audits to ensure compliance
QA Operations Associate II
Dendreon Pharmaceuticals
04.2010 - 12.2012
- Perform batch record preparation, issuance and review
- Issuance of controlled labels and forms
· Perform batch record closure and product disposition - Review and approve GMP controlled documents including SOPs, batch records and test methods
- Ensure full GMP compliance for disposition of raw materials and components
- Review, approve and track closure of deviations, non-conformances, OOS and corrective actions
- Provide support for investigation and recall of non-conforming materials
- Provide support for investigations associated with product failures, product complaints and BPDRs
- Support FDA inspection readiness teams
Technical Writer, Quality Assurance Specialist
Wyeth Pharmaceuticals
05.2008 - 12.2009
- Completed deviation investigations and recorded findings of manufacturing process, collaborating with quality team members and department managers.
- Proved successful working within tight deadlines and a fast-paced environment.
- Edited and proofread technical documents for accuracy and consistency.
- Followed company policies and editorial guidelines to craft thorough, well-written content.
QC Chemist
Teva Pharmaceuticals
12.2005 - 04.2008
- Prepared sample, standard and volumetric solutions, mobile phase.
- Calibrated pH, balances, and Karl Fisher.
- Maintained the QC logbooks for equipment calibration and use, raw materials, in-process (cores) products, finished products, stability samples and USP References Standards for FDA requirements.
- Reviewed peer chemists’ results.
- Experimented in Dissolution, HPLC, UV/VIS, IR, impurity testing, content uniformity, assay, weight variation, Karl Fisher, and particle size.
- Organized intake of samples, progress of testing, and disposal.
Laboratory Technician
OSI Pharmaceuticals
03.2005 - 12.2005
- Duties included calibration of balances and pH meter, temperature monitoring of environmental chambers, glassware maintenance and overall upkeep of laboratory.
- Determined osmolality, pH, clarity, appearance/color and evaluation of visible particles for drug product and drug substance.
- Prepared mobile phases, buffers and sample preparations to be run on HPLC.
- Performed HPLC analysis of drug product to ensure drug authenticity.
Education
Bachelor of Science - Biology
Bloomsburg University of Pennsylvania
Bloomsburg, PASkills
- Product Quality Complaints
- Quality Systems
- Audit Coordination
- Attention to Detail
- Learning and Development
- Documentation Review
- Document Control
- Quality assurance background
- Continuous Improvement
- Internal Audits
- TrackWise
- VEEVA
Timeline
Associate Manager, Quality Assurance
Ferring Pharmaceuticals
07.2016 - Current
Specialist, Quality Assurance
Ferring Pharmaceuticals
10.2013 - 07.2016
QA Operations Associate II
Dendreon Pharmaceuticals
04.2010 - 12.2012
Technical Writer, Quality Assurance Specialist
Wyeth Pharmaceuticals
05.2008 - 12.2009
QC Chemist
Teva Pharmaceuticals
12.2005 - 04.2008
Laboratory Technician
OSI Pharmaceuticals
03.2005 - 12.2005
Bachelor of Science - Biology
Bloomsburg University of Pennsylvania
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