Quality Assurance Chula Vista

David Haviland

*** *** *** ****, ***** Vista, CA 91910 619-***-**** ***********@*****.***

Education

MASTER OF EDUCATION, SECONDARY EDUCATION APRIL 2021 GRAND CANYON UNIVERSITY BACHELOR OF SCIENCE MAY 2015 SAN DIEGO STATE UNIVERSITY

· Major: Microbiology

Skills & Abilities

· NDA, IND, IMPD authoring assistance experience.

· Veeva Rim and Quality systems.

· Track stability schedules at contract service organizations

· Possesses an understanding of Quality Assurance and Process Control

· Possesses GMP/GLP Written Documentation Skills

· GLP testing with HPLC, KF, Dissolution and FTIR

· Reviewing GLP Analytical raw data, stability data sheets, calculations.

· Author and/or reviewer of SOP revisions

· Excellent interpersonal and communication skills Professional Experience

NEUROCRINE BIOSCIENCES SAN DIEGO, CA JUN2022- PRESENT SPECIALIST, ANALYTICAL DEV STABILITY APR2024-PRESENT

· Track stability test schedules at contract service organizations

· Reviews and/or approves stability protocol

· Review, summarize and trend stability data with statistical software such as SLIMstat

· Determines shelf life and retest periods

· Generate stability protocols, reports and presentations

· Author and/or review department SOPs related to stability programs SCIENTIST STABILITY COORDINATION JUN 2022-MAR2024

· Assist authors and ensures data accuracy for FDA submissions

· Ensures reports/release/stability data compliance with GMP

· Identifies deviations, Out-of-specification results, and out-of-trend results

· Works with Supervisor to investigate deviations, out-of-specifications and out-of-trend results.

· Upload applicable reports into QMS.

BIODURO (CDMO) SAN DIEGO, CA OCTOBER 2018- JUN2022 SCIENTIST / ASSOCIATE SCIENTIST APR 2020-JUN 2022

· Manage GLP CTM stability pulls and stability set downs for QC stability protocols. Page 1

· Executed established GLP Test methods and generated data reports

· Manage lab inventory and maintain GLP stability chambers calibration and validation.

· Review instrument qualification reports and associated data.

· Provide QC, GLP testing for stability studies, raw materials and In process testing.

· Perform GLP HPLC(RP), Dissolution, using Empower software as well as KF. FTIR testing

· Execute and validate incoming GLP test methods.

· Work with QA and MFG departments to maintain GMP timelines. MANUFACTURING OPERATOR OCTOBER 2018-APR 2020

· Provide manufacturing support to complete productions

· Perform daily calibrations for balances, weight sorters, and metal detectors used for productions.

· Provide packaging and labeling support

· Assist in maintaining GMP facilities, including performing manufacturing suite cleaning.

· Work with Manufacturing Leads and Quality Assurance to coordinate and complete line clearances CATALENT SAN DIEGO, CA APRIL 2016 – OCTOBER 2018 MANUFACTURING TECHNICIAN II JANUARY 2018 – OCTOBER 2018 MANUFACTURING TECHNICIAN I APRIL 2016 – DECEMBER 2017

· Provide manufacturing support to complete productions

· Perform daily calibrations for balances, weight sorters, and metal detectors used for productions.

· Provide packaging and labeling support

· Assist in maintaining GMP facilities, including performing manufacturing suite cleaning.

· Work with Manufacturing Leads and Quality Assurance to coordinate and complete line clearances Additional Accomplishments

· Revise SOP for Profill in order to condense verbiage and provide clarity for ease of use

· Work collaboratively with another coworker to revise the SOP for MET 1 Particle Counter in order to add a new model of equipment. Revision included addition of manufacturer’s specifications and applicable instructions for use, which included pictures for ease of use, as well as the addition of a required cleaning step to be performed after use to prevent cross-contamination.

· Represent Manufacturing Department during on site Compliance Enhancement Project - Change Management team, with the end goal of improving multiple processes surrounding cross-departmental changes. Project accomplishments include creating a survey to gather feedback on efficiency of communicating changes, such as changes to SOPs. Also creating a process flow map for receiving new GMP equipment in order to evaluate the efficiency of the procedure. SAN DIEGO STATE UNIVERSITY SAN DIEGO, CA

BRIDGES TO BACCALAUREATE INTERNSHIP SUMMER 2012

· Performing laboratory support activities, including preparing solutions and gram staining bacteria

· Perform research and report findings in a presentation. Page 2

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