PATRICIA GEHRKE, MBA, BS, MT(ASCP)

Cell: 747-***-****

ad36ny@r.postjobfree.com://www.linkedin.com/in/patriciagehrkeMBA

QUALITY ASSURANCE SPECIALIST/ COMPLIANCE AUDITOR

Six Sigma I Kaizen I Lean Green Belt

Versatile results-oriented Pharmaceutical/Biotechnology professional with 22+ years of experience in commercial cGMP manufacturing and plant operations driving improvements to enhance productivity while minimizing quality risks seeking Quality Specialist position.

which will provide opportunities for career advancement and interaction with various industry facets, enhance knowledge and further develop technical skills. Lead internal and external audits/inspections. Recognized for strong organizational skills, cross-functional teamwork, and the ability to work independently to ensure timely project completion. Relationship management with suppliers/CMOs including Quality Systems Management, Inspection Preparedness and Execution.

Areas Of Expertise

Quality Management Systems

21CFR 210 and 211, ICH Guidelines

Regulatory Compliance

FDA/External & Internal Audits/Inspections

Batch Record Issuance/Review/Product Release

Continuous Quality Improvement

Revise/Implement SOPs and Standards

Non-conformance/ Deviations

Corrective Action Preventive Action (CAPA)

Project Management

Cross-functional Team Building

Aseptic Processing

PROFESSIONAL EXPERIENCE

Amgen Biotechnology Thousand Oaks, CA

(Collabera LLC)

Specialist Manufacturing- Contractor, June-September 2023

Managed and authored non-conformance deviations using comprehensive root cause analysis

Collaborated with cross-functional QA teams to confirm similar products/materials did not have similar non-conformance events.

Ensured Compliance with local regulations and Amgen policies, standards, and procedures

GOLDEN STATE MEDICAL SUPPLY (GSMS), Camarillo, CA

Quality Systems Specialist- Lead Auditor, August 2021-February 2023

Responsible for execution of internal and external auditing program and processes, develop audit plan, maintain inspection preparedness, execute audits, draft audit reports, and communicate findings including compliance risks.

Provide Leadership for the development, maintenance, and continuous improvement of Quality Audit System programs and processes throughout GSMS.

Review and evaluate supplier/service providers Supplier Questionnaire and audit response against current FDA regulations and guidelines, 21 CFR: 210 and 211, Eudralex, and ICH Guidance, industry standards and guidelines to assure sufficient controls are in place.

Facilitate risk assessment as identified during site and external regulatory inspections.

Follow up on audit finding corrective actions and establish collaborative relationships with internal/external customers and suppliers.

Effectively follow-up on audit findings with auditees and communicate audit outcomes to management and cross-functional departments.

Supplier Quality Manager, March- August 2021

Managed Supplier Quality systems to include drafting, reviewing, and approving Supplier profiles, Supplier Quality Agreements (QAg), and Quality Assessments.

Reviewed and approved Supply Change Notifications (SCN) to ensure changes did not impact GSMS products and systems.

Attended weekly product launch meetings, ensured Quality Agreements were completed on time to meet new product launch due dates. Presented supplier audit metrics during monthly Management Review Board (MRB). Drafted and implemented SOPs related to supplier quality systems.

Managed Supplier Corrective Action Reports (SCARs) in collaboration with internal stakeholders and Quality Agreement procedures and templates specific to Suppliers and Service Providers.

INTEGRITY BIO, INC., Camarillo, CA

Quality Assurance Associate December 2019- March 2021

Performed batch record issuance and timely review. Released product to meet supplier market deadlines.

Supported/performed supplier qualification activities and internal client audits. Created, reviewed, and approved assigned documents including SOPs, Validation reports, and manufacturing procedures.

Reviewed/closed non-conformances (NCs); assessed impact to manufacturing and CAPAs for reoccurrence.

Performed timely Batch Record review. Released product to meet supplier release deadlines.

KITE PHARMA, INC., El Segundo, CA

Facilities Technical Specialist March 2017-March 2019

Supported Facilities department with primary focus on collaborating with T-cell manufacturing operations and quality assurance to investigate and author non-conformance deviations using comprehensive root cause analysis.

Coordinated efforts across multiple departments to gather supporting justification data to determine appropriate corrective and preventative actions.

Presented non-conformance CAPA updates to daily cross-functional team triage meetings. Created/revised SOPs for Facilities maintenance, calibration, and engineering programs.

Wrote and revised Facilities Maintenance, Calibration, and engineering program Standard Operating Procedures (SOPs).

BAXALTA (formerly BAXTER INTERNATIONAL), Thousand Oaks, CA 1999-2016

Senior Quality Operations Analyst

Spearheaded CAPA management across Facilities, and Quality Control departments. Organized comprehensive root cause investigations targeting non-conformance resolution within 30 days. Advanced continuous improvement initiatives to prevent recurrences. Provided compliance to GMP regulations and assisted in documentation for area operations and support processes.

Defended $800K in final product filling opportunities by identifying and resolving root cause of lyophilizer shelf residue issue as leader of rapid DMAIC cross-functional team.

Expedited collection of reliable investigation data and improved 30-day closure rate by forging productive relationships across organizations.

Quality Operation Analyst

Performed statistical trending on temperature-controlled equipment monitored by Kaye LabWatch system. Participated in quality audits. Defended investigation outcomes during reviews by regulatory agency auditors.

Prevented rejection of $500K in final product by diagnosing and remedying root cause of sterility testing failure as key contributor to rapid DMAIC team.

Reviewed and approved manufacturing NCs and CAPAs. Ensured on-time closure of records.

Lowered pest control costs by $4k annually while boosting service quality by sourcing new vendor.

QA Product Release Associate

Reviewed bulk manufacturing and final batch records for GMP and compliance with FDA, product license, and SOP requirements. Exercised approval authority.

Authored annual product reviews be working with cross-functional team to gather and review product and test data.

Completed 100% of product release activities within established timelines. Dispositioned 100% of bulk intermediate and final packaged lots within established timelines.

CAREER NOTE: Earlier roles for MERCK Pharmaceuticals include:

Pharmaceutical Sales Specialist, Human Health, Los Angeles Territory. Created effective business relationships with health care partners by providing information and marketing materials to increase product awareness and sales.

Vaccine Biotechnician- Manufactured vaccines and Black Widow spider antivenin

EDUCATION

M.B.A. Saint Joseph’s University, Philadelphia, PA

B.S., Biology/Medical Technology, Rutgers University, Camden, N.J.

CERTIFICATIONS/ CREDENTIALS/AFFILIATIONS

Project Management and Business Processes

Lean Green Belt

American Society for Quality

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