Quality Assurance Engineer Resume Salt Lake City, UT - Hire IT People

SUMMARY:

Quality Assurance Engineer in the development area of transdermal drug delivery with expertise in document review, equipment and method validation/verification, Trackwise, and LiveLink.
Background includes working for the world’s largest generic drug manufacturer.
Unique strengths demonstrated in managing multiple development projects as quality team lead assessing cGMP standards and Confidential requirements.
Clinical Trial Material Protocol/Packaging Review and approval
TrackWise administration and support
Project planning and tracking
Meeting facilitation
Reporting timelines to Management
Formulation Research and Development
Cross functional teams

PROFESSIONAL EXPERIENCE:

Confidential, Salt Lake City, UT

Quality Assurance Engineer

Responsibilities:

Provided Quality support for15 development projects, ensuring manufacturing schedules and timely filing to Confidential .
TrackWise support and input towards the implementation of SAP.
Reviewed and approved material specifications, test methods, validation reports and clinical trial material protocols and their packaging.
Quality project management for development activities for on - time regulatory filings.
Provided administrative site support for TrackWise system.
Quality lead fir the transition of development projects to commercial.
Consistently delivered results that exceed performance expectations.

Quality Assurance Auditor

Confidential

Responsibilities:

Routine activities in the development facility that facilitate the clinical and small scale manufacturing schedules required for multiple development projects.
Reviewed Trackwise investigations and provide timely feedback to ensure investigations are complete and defendable.
Quality orientated decision making skills/values used when dealing with various situations to ensure manufacturing and clinical trial materials timelines are met.
Background knowledge in R&D/Formulation facilitated quick review and release of incoming raw materials, finished goods and clinical trial materials.
Provided site quality activities for the global implementation of a new Trackwise system used at the site.

Laboratory Technician and Scientist

Confidential

Responsibilities:

Worked with senior scientist on the research and development of matrix formulations to perform in-vitro skin flux permeation studies and analyze samples to provide insight on formulation selection.
Determined/selected best materials and components for finished matrix systems prior to small scale manufacturing.
Produced highly accurate data.
Consistent and dependable output with consideration to quality and thoroughness.
Excellent problem solving/gap analysis skills.

Confidential, Salt Lake City, UT

Lab Technician

Responsibilities:

Prepared samples for liquid/liquid and solid phase extraction techniques and analysis for drugs of abuse and quantitation.
Analysis if samples on gas chromatography/mass spectrometry (GC/MS) and enzyme multiplied immunoassay technique (EMIT) analyzing equipment.
Method development and research analysis for drug detection using experimental techniques.
Prepared/validated quality control testing samples.
Laboratory hazardous chemical communication coordinator for department.