Cube Hub Inc.
Quality Assurance Specialist
Cube Hub Inc., Baltimore, Maryland, United States,
Job Title - Quality Assurance Specialist I -Grade 25
Location - Frederick, MD
Shift - Shift is Sunday – Wednesday 7am- 5:30 pm
This position will be 100% On-Site***
We are seeking a highly motivated individual to join us as a Quality Assurance Specialist.
In this role you will support the activities of the Quality Assurance department manufacturing site.
The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and client quality objectives.
Responsibilities (included But Not Limited To)
Provide QA support on the floor for productionEnsure process control measures are in place and followed in product manufacturingReceipt and disposition of incoming apheresis material.Oversee and authorize shipment of final productVerify and ensure timely issuance of production documents and labelsReview batch-related documentation and ensure resolution of issues to release and ship product.Gather and report metrics to measure performanceEnsure all product-related Deviations are initiated, investigated and resolved.Ensure that associated CAPAs are initiated and resolved, as needed.Perform lot closure activities.Ensure approval and timely delivery of final product.Ensure products are manufactured in compliance with regulatory and GMP guidelines.Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
Basic Qualifications
BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) ORAssociates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) ORHigh School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).
Preferred Qualifications
BS/BA + 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standardsprefered PHARMACEUTICAL industry experienceExperience with manufacturing investigations, deviations, and CAPA.General knowledge of aseptic manufacturing processes.Proficient in MS Word, Excel, Power Point and other applications..
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Location - Frederick, MD
Shift - Shift is Sunday – Wednesday 7am- 5:30 pm
This position will be 100% On-Site***
We are seeking a highly motivated individual to join us as a Quality Assurance Specialist.
In this role you will support the activities of the Quality Assurance department manufacturing site.
The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and client quality objectives.
Responsibilities (included But Not Limited To)
Provide QA support on the floor for productionEnsure process control measures are in place and followed in product manufacturingReceipt and disposition of incoming apheresis material.Oversee and authorize shipment of final productVerify and ensure timely issuance of production documents and labelsReview batch-related documentation and ensure resolution of issues to release and ship product.Gather and report metrics to measure performanceEnsure all product-related Deviations are initiated, investigated and resolved.Ensure that associated CAPAs are initiated and resolved, as needed.Perform lot closure activities.Ensure approval and timely delivery of final product.Ensure products are manufactured in compliance with regulatory and GMP guidelines.Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.
Basic Qualifications
BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) ORAssociates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 2+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) ORHigh School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).
Preferred Qualifications
BS/BA + 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standardsprefered PHARMACEUTICAL industry experienceExperience with manufacturing investigations, deviations, and CAPA.General knowledge of aseptic manufacturing processes.Proficient in MS Word, Excel, Power Point and other applications..
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