Job Description
Pay is commiserate with experience and ranges bfrom $30-40/hr
Quality Assurance Specialist I - Overnight Wed-Sat Location - Frederick, MD Onsite
*Shift is Wed - Sat 5:00 pm - 3:30 am*
4 days a week / 10 hours a day
Quality Assurance Specialist IWe 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 the 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 quality objectives.
Shift is Wed-Sat 5:00 pm- 3:30 am*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 performanceIdentify continuous improvement actionsEnsure timely resolution and escalation of issuesEnsure 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 assignedBasic Qualifications:
MA/MS in a technical discipline (Chemistry/Microbiology/Engineering or similar) ORBA/BS 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) ORAssociates in a technical discipline (Chemistry/Microbiology/Engineering or similar) and 4+ 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 standardsAbility to effectively negotiate and build collaboration amongst individualsStrong teamwork and collaborative skillsExperience 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 skillsComfortable in a fast-paced environment and able to adjust workload based upon changing prioritiesWillingness to think outside of the box and adapt best practices to a small, but growing environmentMust be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficienciesSelf-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.Does this sound like you? If so, apply today!
