LaToya R. Burkett

SUMMARY

Skills

UPLC, HPLC, Chemistry Laboratory, Pharmaceuticals, Laboratory, SOP writing, Laboratory Supervisor, Quality Management, Lab Start UP, HPLC Method Development, Laboratory Investigations/Root Cause Analysis

PROFESSIONAL EXPERIENCE

Validant Consultant/ICU Medical, Austin, TX 02/2019 – 02/2020

Raw Materials Chemistry Supervisor consultant – Resin Blending/API

Ensured that raw materials laboratory practices comply with current SOPs, ICH guidelines, cGMP, Data Integrity, and regulatory requirements. Directly managed 9 chemists. Indirectly managed 22 chemists across 4 laboratories.

Conducted timely Raw Materials Laboratory Investigations using the DMAIC methodology of root cause analysis.

Identified quality issues and escalated them to management in a timely manner. Worked closely with cross-functional teams to ensure product quality.

Drafted and reviewed quality system records including, but not limited to SOPs, test methods, validation protocols, CAPAs, and other required documentation. Participated as the Quality representative in due diligence activities.

Evaluated and recommended new equipment and technology associated with chemistry testing. Selected and evaluated laboratory vendors.

Coordinated personnel activities such as, vacations, sick time, etc. to ensure there was appropriate coverage in the raw material laboratories at all times; addressed personnel issues; counseled and disciplined personnel as needed; wrote performance appraisals for direct reports; composed performance improvement plans for associates with performance issues and review with Human Resources.

Performed regular, hands-on quality audits of API testing laboratories as well as quality system records.

Avella Specialty Pharmacy, Houston, TX 12/2016 – 01/2019

Chemistry Laboratory Manager

Used USP/ICH/FDA regulations (21CFR211 and USP 797) to set up the laboratory program from scratch.

Was responsible for analytical methods development and instrumentation needs.

Authored and/or reviewed analytical protocols and technical reports.

Developed, implemented, implemented laboratory OOS investigation procedures using DMAIC process improvement methodology.

Worked independently to manage day to day activities for QC of cGMP, manufactured products, and all incoming chemicals.

Drafted, reviewed, and revised Quality Control and Analytical SOPs. Solved complex QC technical issues and provided technical direction to projects internally and externally.

Worked with cross-functional teams to manage finished product, stability program setup, and raw material testing.

Set departmental goals and targets and interfaced with other technical departments on site.

Served as the primary point of contact with internal and external customers.

Managed the department to meet goals for productivity, financial objectives, capital expenses, etc.

Was responsible for environmental compliance and departmental safety programs.

Oversight of laboratory construction and setup operations.

Developed and validated laboratory UHPLC-UV, UPLC-Qda, and Ion Chromatography methods.

Performed chemical analyses independently, as part of team, and supervised laboratory employees in carrying out chemical analyses per cGMP guidelines.

Hired, trained, supervised, and coordinated the work of laboratory employees on projects.

Celltex Therapeutics, Houston, TX 09/2015 – 12/2016

Quality Assurance Manager

Reviewed and improved quality system documentation in accordance with 21 CFR 1271; wrote and/or reviewed Quality Assurance (QA) standard operating procedures to assess cGMP compliance on issues relating to sterile biologics manufacturing.

Performed audits of manufacturing and quality control practices and procedures, including internal audits, vendor qualification audits, and audits of investigator sites.

Supervised the QA Specialist on audit-related work, during final production and quality control record review, and during the release of finished products.

Led inspection and accreditation procedures, including leading and overseeing audit/inspection preparation activities and remediation plans.

Conducted weekly quality review meetings and prepared reports.

Developed and conducted GXP and safety training courses for all staff, post-audits, and maintained staff GMP training records.

Managed the document control system, including document issuance and retirement, and maintenance of document history files.

Led OOS lab investigations and implemented and evaluated the adequacy and effectiveness of corrective and preventive action plans.

Prepared, organized, tracked, and performed QA review of FDA submissions to include INDs, Annual Reports, Supplements, etc.

Provided interpretation of GMP/GTP/GCP regulatory requirements as they applied internally.

Accomplishments

Improved SOPs

Prepared the company for third party audits

Organized SDS

Equipment Calibrations

Process Validations

Clinical Study Documentation

Control Solutions Inc, Pasadena, TX 08/2013 – 09/2015

Quality Assurance/Quality Control and Chemistry Laboratory Manager

Established the quality system and wrote all Standard Operating Procedures for safety, product quality assurance, QC/analytical chemistry laboratory, and company policy.

Partnered successfully with Regulatory, Production, Purchasing, and Corporate to reduce customer complaints.

Spearheaded cross-functional initiative to achieve site safety training. Strengthened company's business by leading implementation of quality assurance and quality control.

Trained, coached, and mentored staff to ensure smooth adoption of new quality laboratory and QA line audit program.

Developed a Quality Manual which describes the company quality management system and outlines the quality policy.

Managed the document control system, including document issuance and retirement, and maintenance of document history files.

Responded to customer requests for Certificates of Analysis.

Maintained trending data on lab test results as well as customer complaints and corrective actions.

Maintained Deviation tracking system. Led nonconformance investigations to determine root cause of failures.

Worked with cross-functional teams to implement process improvements. Suggested product improvements that improved product performance.

Supervised the QA Specialist on audit-related work, during final production and quality control record review, and during the release of finished products.

Helped develop the Quality program at the CSI facility and associated facilities.

Developed written procedures production operation to manage product quality.

Developed analytical methods for analyzing CSI products to assure quality meets product label claims.

Worked with Global Procurement Manager and Purchasing Manage to source ingredients for New Product Development.

Supported Outside Operations Manager and Global Procurement Manager with outside Tolling centers.

PharMEDium Services Llc, Sugar Land, TX 2007 – 2013

Chemistry Laboratory Supervisor

Was responsible for startup and improvement of GMP Quality Control laboratory.

Led a small team of chemists in performing testing on incoming material, final product, and manufacturing monitoring to assure the quality of products manufactured. Tests included capillary electrophoresis and UPLC/MS to prove potency and identity of end product samples. Managed 2 chemists.

Provided scientific support to aid resolution of customer product quality concerns.

Provided validation services for New Product Development and existing product re-validation.

Implemented and executed an ongoing laboratory quality improvement and development program in support of the overall business strategy.

Was responsible for development and quality training of all laboratory personnel. Participated in internal investigations of potential issues to determine root cause and appropriate next steps.

Implemented new quality system procedures and technologies in support of business demands.

Managed vendor selection, contracts, and agreements.

Provided support to customer and regulatory audit activities.

Introgen Therapeutics Inc, Houston, TX 2005 – 2006

Quality Control Associate

Wyeth Vaccines, Sanford, NC 2003 – 2005

Quality Control Scientist

FDA – Office of Regulatory Affairs, Jefferson, AR 2002 – 2003

Microbiology Lab Technician

Baxter Healthcare, Rochester, MI 2000 – 2002

Quality Control Analyst

EDUCATION

Bachelor of Science in Animal Biology/ Minor in Chemistry; 1994 – 1999

Louisiana Tech University; Ruston, LA

CERTIFICATIONS/LICENSES/MEMBERSHIPS

08/2018 to 08/2021

CPGP, Certified Pharmaceutical GMP Professional (ASQ Certified)

CQA, Certified Quality Auditor (ASQ Certified)

GROUPS

American Society for Quality; 01/2016 to Present

The Connection Women's Leadership Group; 09/2016 to Present

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