Quality Assurance Data Entry

Collins Latimer

Raleigh, NC • *******.*******@*****.*** • 919-***-****

Quality Assurance Leader

Dynamic, solutions focused quality assurance leader with over 20+ years of experience in the science, agricultural and environmental related fields. Proven capabilities performing as a team member or individual contributor through leadership and mentorship skills with strong analytical and problem-solving abilities. Strong clinical/commercial based data and project management skills determined for a positive outcome.

— Areas of Expertise —

Horticulture LIMS Super User Cell Culture/Purification Trackwise Technical Expert

Chemistry/Microbiology Lab Methodologies & Instrumentation DeltaV Automation Captivate Oracle SCRUM

Infor10 Visio UAT IT Operations GLP/cGMP/ICH-GCP/EU/FDA (GxP) Compliance

USP, EP, JP, BP Compendia ISO-17025 ISO-9001 Risk Management

Clinical to Commercial Launches Manufacturing Change Control Non-Conformity Investigations CAPA Utility/Environmental Monitoring Cross-Site Collaboration

Microsoft Office Applications: Access, Outlook, Excel, Word, PowerPoint, OneNote, SharePoint, Empower, Labware, PMS

Professional Experience

Horticulture, Self-employment/Entrepreneur

Raleigh, NC Aug 2022-Present

Currently growing multiple varieties of organic micro greens under USDA guidelines for local markets; including farmers markets, restaurants and freeze drying operations. Processes include soil cultivation (micro flora), water and indoor growing maintenance (lighting, water/air filtration, pH/conductivity sampling), seed procurement, plant harvesting and distribution.

Catalent Pharma Solutions Morrisville, NC

QA Auditor April 2020-Aug 2022

Responsible for Auditing a variety of methodologies as applied to various stages of pharmaceutical development, and verifying accurate transcription of raw data into Certificate of Analysis (COA), Text reports, and issuing completed COA’s/Text Reports to the Project Director for the relevant customer. Auditing the testing data associated with final reports for compliance to all applicable SOPs and regulatory requirements. Perform routine GMP walkthroughs of laboratory areas for compliance and preparation for third party audits. Discuss issues in real-time with lab staff as discovered during final report auditing, laboratory walkthroughs, or other internal audits. Archive study phase documentation following review of testing data and issuance of final reports in a timely manner. Assist in other non-routine duties for investigation(s) support. Perform review and approval of method/SOP revisions.

Lead Scientist

Responsible for writing investigations in the Biologics department and collaborating with site management for CAPA’s (Corrective and Preventive Actions) in compliance with regulatory standards.

Hemp Hill Farms, LP Oxford, NC

Consultant/ Company Co-Founder, CQO 2018 – 2020

Responsible for startup operations in accordance with the 2018 Hemp Pilot Program, GMP ISO-9001 requirements, licensing process, and quality agreements. Experience with (hemp) cultivation, harvesting and curing within a small-scale farm and greenhouse operation. Assisted with final CBD/CBG product formulations for existing extraction methods using bench scale laboratory method validation testing.

Key Accomplishments:

Member of NCIHA

Transitioned into a GMP compliant company by researching established federal guidelines and implementing various requirements for operations

Biogen (2001-2019) Durham, NC

QA Associate 3 – Large Scale Manufacturing Support 2016 – 2019

Identified corrective and preventative actions (CAPA’s) after QA review of internal investigations and in response to audit findings. Helped implement and support CAPA effectiveness checks (CAPA-E), and approval of Remedial Action Reports (RAR), Non-Compliant deviations, planned exceptions, alert/action (utility/EM) investigations, and change control for all aspects of production/manufacturing and Quality Control. “On the Floor,” final review and QA approval of SLR/BPR’s for adherence to GMP standards. Support implementation of clinical campaign documents and review and approval practices in accordance with GCP/ICH standards. Responsible for Clinical Process Flow Diagram (PFD) reviews and Formula approvals for clinical production campaigns. Trained new hires for various QA positions, along with guided tours and overview of the high-purity generation/distribution (WPU/WFI) system. Performed QA review of production related SOP/work instruction revisions, Purification column/cassette binders and release of equipment for production use. QA overview of change in/change out processes for production equipment between MFG campaigns. Site administrator for Trackwise (Sparta Systems) exception database, and revisions support of document type workflows and UAT/SCRUM testing. Support regulatory and partner audits in various functions. Support exceptions transformation by providing training to site management. Trending data and metric reports for exceptions included in all QA roles referenced below

QA Associate II- Associate III - Investigations 2014-2016

Exceptions support and QA review of internal investigations, Corrective and Preventive Actions, Remedial Action Reports, Planned Exceptions, Alert/Action Excursions and Patient Services Risk Map exceptions program. Provided third party and regulatory audit support. Trackwise administrator function for RTP site. Taught classroom-based trainings for Trackwise production use. Exceptions transformation training support-Project lead for global based Trackwise e-learning platform for all employees. Author of Manufacturing/Facility/Equipment related exceptions section of Annual Product Reviews (APR). Support Trackwise (Sparta Systems) exception database system revisions of document type workflows, including exception transformation (event) workflow by providing UAT/SCRUM testing and classroom training. Performed QA owned SOP revisions when required.

QA Associate II - OTF 2011-2014

“On the Floor,” final review and QA approval of SLR/BPR’s. Conducted exceptions review/approvals and Alert/Action QA SME. Routine audit support with monthly walkthroughs of manufacturing areas and warehouse for general GMP observations and review of equipment critical alarms. Support third party/regulatory audits in various functions. Trackwise administrator function for RTP site.

QA Associate I- Associate II Laboratory QA 2008-2010

Provided support and QA review of Deviations/Investigations, Corrective and Preventive Actions (CAPA), Remedial Action Reports. Planned Exceptions, Laboratory Exceptions (Invalid Assays/AR/OOS), Change Controls and Alert/Action Excursions while reviewing the final batch production QC release test data for QA authorization. Reviewed and released Certificate of Analysis (CofA), raw material data packets, instrument validations binder(s), and critical alarms. Supported audit processes. Trackwise administrator function for RTP site.

Additional Positions

QA Associate I – Exceptions Management (2006-2008)

2001-2006 QC Microbiology Technician

Sr. Technician I (2004-2006), Tech III (2003-2004), Tech II (2001-2003),

Technical expert and lead for the environmental / utility monitoring (EM/UM) programs. EM/UM sampling coordinator and LIMS super user, EM/UM batch release data review. Executed and oversaw validation protocols for EM, UM, facility certification, DQ, IQ, and OQ protocols for new instruments (particulate Counters, ARTI/Climet). Authored EM/UM quarterly technical report and presented to senior leadership at quarterly meetings. Proficient in all areas of UM and EM (viable, non-viable) sampling/testing. Performed bioburden and endotoxin (LAL) testing on in-process, release and utility samples. Performed Dynamic air particulate monitoring in class 100 areas with cell culture manufacturing groups. Partnered with functional groups to revise, validate and implement electronic alert/action (EM/UM excursions) workflow system (Trackwise). Performed investigational studies with manufacturing for continuous improvement of procedures and cleanroom practices.

Key Accomplishments:

Created dashboards to help with KPI's and turnaround time metrics for various non-conformance reports in Trackwise.

Author of manufacturing/facility/equipment related exceptions sections of Annual Product Reviews (APR).

Development of an e-learning platform to move Trackwise training for new employees from a classroom training into a computer-based module as part of new hire training requirements.

Helped implement on the floor review of manufacturing records for real-time corrections and increase turnaround times for batch production records from 1 week to 24 hours.

Revision of Alert/Action Trackwise workflow from a linear path to a tabular format so that affected area, Lab assessment and Utility system owner can complete sections in unison thus reducing turnaround time from 45 days to 20-30 days

Helped implement Exceptions Transformation initiative to change deviation classifications to include “event” type workflow, significantly reducing TAT, and giving focus to more value added investigations.

Education and Credentials

Associate of Applied Science – Environmental/Pharmaceutical

Wake Technical – Garner, NC

Professional Development:

Hazmat Certified

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