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Paquita Poole

205-***-****

adzb99@r.postjobfree.com

Work Experience

Quality Assurance Auditor II

Avanti Polar Lipids- Alabaster, AL

November 2021 to Present

Responsibilities:

• To ensure compliance with United States Food and Drug Administration’s current Good Manufacturing Practices.

• Ensure compliance with establish quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations.

• Determines root cause of non-conformance and develops strategies to address issues. Provides audit questionnaire reports to management.

• Execute duties as required associated with supporting the internal auditing process. Quality Assurance Document Control / Batch Record Review Oxford Pharmaceuticals - Birmingham, AL

October 2017 to October 2019

Responsibilities:

• Lead the company’s Quality Assurance (QA) documentation activities, oversee cGMP compliance initiatives, and manage QA resources at a startup pharmaceutical company.

• Lead the site Quality Assurance documentation functions including agency audits, document control, label printing, label issuance, product specifications, component specifications, raw material specifications, validation protocol and report review/ approval, vendor qualification program, customer audits, internal audits, vendor audits, record review, product release, and GMP training for pharmaceutical facility.

• Organizing the on-time release of finished goods, raw materials, packaging components, and labeling to meet production and distribution requirements by the sampling of raw materials, in-process, and finished product and the auditing of all receiving, manufacturing, packaging, and analytical records for cGMP compliance. Vendor, Customer, and Internal Audit Program, Vendor and Customer Complaint Program. Maintaining and re-enforcing cGMP compliance, Non-conforming Materials Policy, Out of Specifications Policy, and Training Records.

Owner

Helping Hands In-Home Caregivers, LLC- Memphis, TN October 2012 to December 2016

Responsibilities:

• Help maintain optimal level of independence for older adults in the comfort of their own homes. 2

Quality Assurance

Endo Pharmaceuticals Inc - Chadds Ford, PA

February 2009 to June 2013

Responsibilities:

• Organized, and prioritized work load including SAP to ensure product is available for distribution and worked closely with Supply Chain to prevent back orders.

• Conducted and wrote investigation/deviation reports as required.

• Performed inspection of drug product lots at the contracted distribution centers in Memphis, TN and Harrisburg, PA for commercial distribution.

• Reviewed/ approved inspection paperwork to ensure completeness and accuracy.

• Oversaw and participated in rework activities to ensure inspections and statistical sampling were performed appropriately to ensure compliance with internal standards.

• Performed inspection of retain sample labeling components for evidence of deterioration.

• Performed GMP audit of Distribution Center, and monthly walk-through to ensure facility is appropriately maintained in compliance with housekeeping and sanitation practices.

• Coordinated with cross functional team to resolve issues

• Maintained various QA databases, compiled metrics and issued trend reports.

• Ensured written procedures reflect current practice and implemented necessary revisions via electronic document management system.

• Provided on-the-job training to others as required.

• Skilled in participating in rework activities to ensure inspections and statistical sampling were performed appropriately to ensure compliance with internal standards.

• Knowledge of 21 CFR 210 & 211 and Microsoft Office (Microsoft Word, Excel and PowerPoint).

• Experience performing inspections in accordance with statistical sampling plan, and ensuring compliance with standards

•Documented/recorded information- entering, transcribing, recording, storing or maintaining information in written or electronic format.

•cGMP Batch Record Review process.

•cGMP Document Control process.

Case Manager

Seraaj Family Homes Inc - Birmingham, AL

August 2008 to January 2009

Responsibilities:

• Participated in planned visitation between foster children and their biological parents and/or extended family members.

• Developed treatment plans for foster children, conducted bi-weekly home visit surveys, and provided in service training to staff personnel.

Pharmacy Tech II/Doctor Calls

Caremark Pharmacy - Birmingham, AL

March 2006 to August 2008

Responsibilities:

• Performed data entry, created and maintained customer account profiles for processing prescription orders.

• Reviewed, scanned and processed prescription mail orders in the system, and handled telephone inquiries from customers and physicians.

3

Education

MBA

University of Phoenix

2024

Bachelor of Arts

(Psychology) Auburn University - Auburn, AL

2008

Associate in Science - Biology

Lawson State Community - Birmingham, AL

2002

Additional Information

Skills:

• GMP audit, Microsoft Word, Excel and PowerPoint, 21 CFR 210 & 211, SOP, SAP

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