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Work Background
Iveric BioQuality Systems Coordinator
Mar. 2022 - Jul. 2024Remote-Oversee quality assurance processes and site-wide training programs using ComplianceWire, ensuring alignment with FDA and industry standards. - Led the implementation and validation of ComplianceWire and Veeva Vault systems to enhance regulatory compliance and operational efficiency. - Ensured adherence to GCP and GMP standards, supporting quality control during a company's transition to commercial production after successful clinical trials. - Played a pivotal role in an FDA audit resulting in no 483 observations, showcasing expertise in regulatory compliance and audit readiness.
HUVEPHARMA, INCSenior Quality Assurance Specialist
Jul. 2021 - Mar. 2022Longmont, Colorado, United StatesHuvePharma: - Senior QA Specialist reporting to the Quality Manager in St. Louis, MO, with a focus on quality control and regulatory compliance. - Perform critical QA functions, including document revisions, change control, MCSRs, APRs, batch record reviews, deviations, and CAPA management. - Ensure compliance with FDA regulations and industry standards through meticulous oversight of quality processes and documentation. - Mentor and oversee less experienced Quality Assurance Associates, fostering a culture of quality excellence and continuous improvement.
Neva AnalyticsQM/QC specialist
Oct. 2020 - Mar. 2021Longmont, Colorado, United StatesNeva Analytics: Title: Quality Management/Quality Control Specialist: - Reviewed data on early-stage pre-clinical/clinical drugs, biologics, and medical devices, evaluating and troubleshooting experimental testing methods. - Ensured quality control data integrity and audit readiness, supporting successful FDA audit preparation. - Reduced laboratory investigations and exception reports by advising chemists on best practices for testing and optimizing early-stage methodologies.
Ananda ScientificRegulatory and Quality Manager
Sep. 2017 - Oct. 2018Greenwood Village- Advised the CEO and leadership team on FDA and FTC regulations, ensuring compliance in a startup environment unfamiliar with regulatory requirements.
- Evaluated and revised product labeling and advertising to align with FDA and FTC regulatory standards, ensuring accuracy and compliance. - Directed policy updates and developed SOPs to establish a comprehensive quality program, including implementing GMPs, a document control system, and employee training. - Oversaw quality control processes by conducting investigations, reviewing data, certifying analyses, and approving the release of new products.
Agios PharmaceuticalsQuality Control Scientist - contractor
Aug. 2016 - Oct. 2016remote- Conducted comprehensive reviews of laboratory data, method validations, and validation reports to ensure GMP/GLP compliance and data validity for an innovative rare disease drug. - Supported global product release by remotely reviewing analytical laboratory data from international sites, ensuring accuracy and completeness. - Consistently met strict deadlines, contributing to timely product approval and market readiness.
Front Range LaboratoriesQuality Control Officer-Contractor
Jun. 2016 - Aug. 2016Loveland Colorado• Managed instrumentation for microbiology and quality control at Front Range Laboratories in Loveland, Colorado.
• Wrote SOPs to address gaps in GMPs, leading to improved compliance and efficiency.
• Identified and resolved GMP infractions, such as stability chamber issues, ensuring accurate temperature and humidity recordings.
• Implemented Investigations and exception reports, preventing customer loss due to frequent electrical outages.
HospiraQA data reviewer / QC Document Revision Specialist
Nov. 2014 - Aug. 2015Boulder, COIn my role as a QA data reviewer/QC Document Revision Specialist at Hospira in Boulder, CO, I was responsible for reviewing quality control stability data, auditing documents, and revising procedures to ensure compliance with regulations and ease of use.
-Managed Stability program. -Assisted in planning new product launches. -Performed analytical testing.
Colorado Department of Public Health and EnvironmentVolunteer
Oct. 2013 - May. 2014DenverAssisted in the writing and editing the quality program to align with the Manual of Certification of laboratories analyzing drinking water (EPA) and ISO/IEC 17025:2005 regulatory requirements. Pick up from scratch new regulations and converted them into a valuable system for analysts.
HospiraQA Data Reviewer, Stability Coordinator, Analyst III
Jan. 2006 - May. 2013Boulder Colorado• Quality Control Analyst, testing raw material, in-process and final product API data, and stability samples, and development work. Promoted to Stability Coordinator with the responsibility of entire stability program and migrated from a three-product site to a 14-15 product site. Represented stability during FDA audit with no 483s. Wrote Investigations, Exception, Corrective Action Preventive Actions reports, change controls, and standard operating procedures. Gathered information for corporate in response to the FDA oversite committee issues during a later audit that required remediation. Saved the company from three significant errors before the FDA audit. Two were major software issues and one a spreadsheet calculation mistake, all giving inaccurate results, involving months of data. Coordinated and participated in the quality training program. At the end, involved in remediation.
SandozProfessional III, Team Lead (started as Chemist I)
Mar. 1997 - Jan. 2006Broomfield Colorado• Led a team of six chemists at Sandoz, promoting teamwork through bi-monthly meetings and training sessions on new SOPs and regulations.
• Addressed issues and recognized team efforts that consistently met and exceeded deadlines, fostering team cohesiveness and resolving conflicts.
• Planned and coordinated training for new employees, ensuring the team's quality training program was successful.
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