Quality Assurance Specialist - LanceSoft Inc
Frederick, MD 21704
About the Job
Job Title : Quality Assurance Specialist I
Location : Frederick, MD - Onsite
Duration : 6 months contract
Shift : Sunday Wednesday 7:00-AM - 5:30-PM
Pay Range : $30.00 - $35.00 USD hourly on W2
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.
Location : Frederick, MD - Onsite
Duration : 6 months contract
Shift : Sunday Wednesday 7:00-AM - 5:30-PM
Pay Range : $30.00 - $35.00 USD hourly on W2
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.
Source : LanceSoft Inc
