Quality Specialist

PROFESSIONAL SUMMARY

Quality Assurance • Quality Control • Deviation Management • Lab Scientist

Individual in the Pharmaceutical Industry with experience developing and managing different processes that increase overall quality, safety, and proficiency. John

Blue

East Greenville PA

Phone #: 610-***-****

Linkedin:

www.linkedin.com/in/john

-blue-03b385198

CORE EXPERTISE

• Quality Management

• Quality Improvement

• Writing Deviations

• Technical Writing

• Investigations/CAPA/

Root Cause Analysis

• Technology: Microsoft

Office, Power BI, LIMS,

QAD, VeevaVault

EDUCATION

East Stroudsburg

University of

Pennsylvania

BS, Exercise Science, 2019

CERTIFICATIONS

Aseptic Gowning, 2020

HIAC, 2023

LIMS, 2023

EXPERIENCE

Sharp Macungie, PA

Quality Specialist 08/2024 - Present

• Review and approve quality documentation, including forms, work instructions, shipping requirements, and specifications.

• Foster and support customer relationships regarding quality-related inquiries and issues.

• Implement methods for process control, improvement, testing, and inspection to enhance operational efficiency.

• Ensure compliance with internal and external testing and inspection requirements.

• Conduct in-process inspections and AQL sampling as required.

• Collaborate with the training department to develop and implement new training opportunities.

Merck West Point, PA

Deviation Management Specialist-I 02/2024 - 06/2024

• Provided technical support to manufacturing operations by resolving and reducing process deviations, developing corrective and preventative actions, and leading investigations in manufacturing and laboratory settings.

• Offered scientific support for manufacturing areas within the Client’s Manufacturing Division (CMD).

• Conducted troubleshooting and root cause analysis of laboratory test failures and atypical manufacturing events.

West Pharmaceutical Services Exton, PA

Associate Scientist Particle Group 01/2023 - 02/2024

• Performed analysis utilizing various established and experimental test methods.

• Employed qualitative and quantitative instrumentation for data reconciliation and analysis.

• Utilized particle analysis techniques and software, contributing to the preparation of comprehensive technical reports.

Veltek Associates Inc. Malvern, PA

Quality Control/Assurance 05/2020 – 01/2023

• Conducted environmental and personal monitoring for product sterility testing, including filter integrity assessments.

• Monitored and recorded equipment performance in varying temperature incubators on a daily basis.

• Executed quality control checks across multiple production lines to ensure compliance with standards.

Veltek Associates Inc. Malvern, PA

Production Associate 05/2020 – 08/2020

• Accurately assembled products in accordance with Standard Operating Procedures and customer specifications.

• Certified to operate within an aseptic environment, ensuring adherence to safety and quality protocols.

• Inspected finished products for compliance with labeling, seals, and weight requirements.

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