What are the responsibilities and job description for the Quality Assurance Specialist I position at ICONMA?
Location: Frederick, MD
Duration: 6 months
Description:
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 at Client’s Frederick, MD 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 production
Ensure process control measures are in place and followed in product manufacturing
Receipt and disposition of incoming apheresis material.
Oversee and authorize shipment of final product
Verify and ensure timely issuance of production documents and labels
Review batch-related documentation and ensure resolution of issues to release and ship product.
Gather and report metrics to measure performance
Identify continuous improvement actions
Ensure timely resolution and escalation of issues
Ensure 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.
Perform other duties as assigned
Basic Qualifications:
BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) OR
Associates 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) OR
High 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 standards
Ability to effectively negotiate and build collaboration amongst individuals
Strong teamwork and collaborative skills
Experience with manufacturing investigations, deviations, and CAPA.
General knowledge of aseptic manufacturing processes.
Proficient in MS Word, Excel, Power Point and other applications.
Strong interpersonal, verbal and written communication skills
Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
Willingness to think outside of the box and adapt best practices to a small, but growing environment
Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
Duration: 6 months
Description:
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 at Client’s Frederick, MD 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 production
Ensure process control measures are in place and followed in product manufacturing
Receipt and disposition of incoming apheresis material.
Oversee and authorize shipment of final product
Verify and ensure timely issuance of production documents and labels
Review batch-related documentation and ensure resolution of issues to release and ship product.
Gather and report metrics to measure performance
Identify continuous improvement actions
Ensure timely resolution and escalation of issues
Ensure 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.
Perform other duties as assigned
Basic Qualifications:
BA/BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) OR
Associates 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) OR
High 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 standards
Ability to effectively negotiate and build collaboration amongst individuals
Strong teamwork and collaborative skills
Experience with manufacturing investigations, deviations, and CAPA.
General knowledge of aseptic manufacturing processes.
Proficient in MS Word, Excel, Power Point and other applications.
Strong interpersonal, verbal and written communication skills
Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities
Willingness to think outside of the box and adapt best practices to a small, but growing environment
Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
As an equal opportunity employer, ICONMA provides an employment environment that supports and encourages the abilities of all persons without regard to race, color, religion, gender, sexual orientation, gender identity or express, ethnicity, national origin, age, disability status, political affiliation, genetics, marital status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
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