Junior Qa Support Specialist

Delores J Perry

Loganville, GA ***** *****.********@*****.*** 770-***-**** linkedin.com/in/deloresjperry

Quality Assurance Professional

Auditing • Compliance • Team Leadership

Quality professional with over 10+ years of experience. Recently earned a Regulatory Sciences Master’s degree. Blends quality assurance (QA) experience with academic training to offer solid skills in quality, regulatory science, and project management for product improvement, sustainable sourcing, and strategic and practical planning in compliance. Proven ability to effectively communicate across teams within an organization. Ensures project objectives meet compliance and regulatory requirements.

Core Competencies

Internal/External Facility Auditing • Project Management • Field Trial Coordination • Document Control/Management • Standard Operating Procedure (SOP) Writing • Database Management • Team Training

• Archive Management • Customer Service/Relations • Product Label Review • Change Control • ISO 9001 Lead Auditor Trained • Corrective Action/Preventative Action (CAPA) • Quality Management Systems (QMS)

• Good Laboratory Practices (cGLP) • Good Manufacturing Practices (cGMP)

Relevant Course Work

FDA and USDA Applications and Submissions • Quality Control/Quality Assurance • Process Control and Validation

• Ethical Issues in Research • Project Management •Trial Design & Monitoring

Quality Assurance Experience

Quality Assurance (QA) Auditor -Arxada (formerly Lonza), LLC, Alpharetta, GA 2017 – Present

Perform in-life critical phase inspections for compliance with the GLPs, study protocol and SOPs. Review protocols, study and facility data and final reports for compliance with GLP standards. Liaise with regulators upon site visits and audits.

Compliance

Audit protocols, study data, facility documents, and final reports for GLP compliance with a 98% margin of completion by requested due date

Manage and audit up to 5 studies per week, including chemical/physical evaluations and long and short-term storage stability studies

Prepare and conduct independent, system-based audits of internal and external processes to verify conformance to regulatory and environmental, health and safety requirements

Apply subject matter expertise in the review, development and enhancement of company standards, policies, and procedures in addition to regulatory requirements

Develop monthly status reports identifying study progress and time management, improving study completion rates

Team Leadership

Lead monthly training of up to 15 laboratory personnel on GLP standards and practices

Supervise and mentor junior QA auditors on the team

Seek proactive insights and knowledge on industry trends and technology that will further improve the organizations value proposition and performance.

Ensure accomplishments of departmental and corporate-wide long-term goals and solutions

QA Manager/Business Support Specialist - BIO-LAB, Inc, A KIK Company Lawrenceville, GA 2012 – 2017

Managed the GLP program. Performed as study sponsor/representative for contract GLP studies.

Audited facilities, equipment, records, and reports to identify and reduce areas of potential noncompliance

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Worked in team environment to identify gaps and document requirements to improve customer satisfaction

Organized training of 20+ laboratory personnel on GLP standards and practices

Supported sunscreen product development to ensure compliance with the 21 CFR 58 guidelines, Chemistry Manufacturing and Controls (CMC) and cGMP requirements

Approved qualifications of new suppliers or materials and their associated purchase specifications through Bio-lab’s internal Vendor Material Qualification (VMQ) process

Performed product label reviews

Senior GLP Specialist BIO-LAB, Inc, A KIK Company Lawrenceville, GA 2010 – 2012

Performed study director, study representative, and/or study chemist responsibilities with compliance to GLPs. Coordinated internal/external GLP studies for new and existing pesticidal and non-pesticidal products, and raw materials.

Liaise with Internal & External Stakeholders

Leveraged and influenced leadership and operations to support, communicate and drive regulatory compliance

Led 5 federal EPA audits with no significant written findings or concerns

Directed team to gather appropriate records and served as primary point-of-contact with auditing staff

Negotiated agreements and functioned as study sponsor/representative for external studies

Coordinated contract studies such as toxicology, ecotox, microbiological, and analytical

Maintained consistent interaction with product development, regulatory, quality assurance, manufacturing, laboratory operations and EH&S to ensure compliance with the 40 CFR 160 and the Series 830 guidelines

Systems & Processes

Wrote and reviewed 100% of protocols, final reports, amendments, and deviations for GLP studies

Ensured compliance of over 180+ studies with federal requirements of the EPA, OPPTS guidelines, and the FDA

Incorporated guidelines regulations of global agencies such as OECD, the European Medicines Agency (EMA), and the Australian Pesticides & Veterinary Medicines Authority (APVMA) as required

Assessed and provided feedback on the quality of corrective action plans to ensure the effective identification, reduction, and mitigation of risks associated with manufacturing, procurement, and regulatory issues

Interpreted study results and provided technical expertise for the development of product specifications, Safety Data Sheets (SDS), and establishment of quality assurance and manufacturing standards

Master’s Thesis Project

Established a risk-based decision-making tool that could be used by quality professionals to optimize acquisition practices of US pharmaceutical corporations acquiring a product line regulated by Good Manufacturing Practices.

Early Career Experience

Senior Chemist, BIO-LAB, INC, Lawrenceville, GA 2006 – 2010

GLP Coordinator/Research Chemist, BIO-LAB, INC, Lawrenceville, GA 2000 – 2006

Professional Affiliations

Member, Society of Quality Assurance (SQA) • Member, American Chemical Society (ACS)

• Lifetime Member, Girl Scouts of America • Member, Delta Sigma Theta, Inc.

Education

Master of Science (MS), International Biomedical Regulatory Sciences, August 2020, University of Georgia, Athens, GA

Certificate, Clinical Trials Design And Management, University of Georgia, Athens, GA

CERTIFICATE, CLINICAL RESEARCH, Gwinnett Technical College, Lawrenceville, GA

Bachelor of Science (BS), CHEMISTRY, Morris Brown College, Atlanta, GA

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