Determined and well-rounded individual with more than 30 years working as Quality Assurance Professional within thePharmaceutical industry. Detail-oriented professional offering skills in cGMPs, data integrity and good documentation practices.
Overview
24
24
years of professional experience
Work History
Sr. Scientist-QA
Eli Lilly
01.2010 - 04.2024
Designed and led inspections for lab compliance readiness
QA support of five lab areas, such as raw materials, in-process, stability, incoming inspection components, and QC chemistry lab areas
Served as a Quality contact for quality issue resolution
ALCOA+ lead for Lab document project
Computer Software Validation QA certified for qualification and validation of computer controlled analytical instruments
Track and trend deviation records
Performed effectiveness checks for TrackWise record CAPAs
Simultaneously managed several complex projects, meeting all pertinent milestones.
Managed multiple concurrent ALCOA+ projects with strict deadline, prioritizing tasks effectively to maintain progress without sacrificing quality or accuracy.
Sr. Associate-QA
Eli Lilly
01.2003 - 01.2010
Reviewed parenteral semi-finished batch records and issued certificate of manufacture for compliance with local SOPs and Global Standards.
Compliance checks of manufacturing and filling areas. Observed non-compliant issues and if necessary, escalated critical issues to line management.
Streamlined operational efficiency by identifying areas for improvement and proposing actionable solutions.
Suggested and implemented a more efficient way to streamline batch reviews by condensing QA batch record approvals.
QA Engineer
Abbott Laboratories
01.2000 - 09.2003
Company Overview: (Diagnostics Division)
Performed test method validation remediation (test method validation review/approval of protocols and reports).
QA lead in cross-functional meetings for test method validation and test protocol specification reviews.
Instrument remediation of IQ/OQ/PQ (qualification/requalification of analytical instruments) through review and approval of qualification records.