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For your reference, we have included the original job posting below.
Quality Specialist I - Biologics US
Job Number:
25715554
Company Name:
BioReliance
Job Location:
Rockville, MD US
Job Category:
Healthcare & Medical
Quality Specialist I - Biologics US
Quality Specialist I - Biologics US Location: Rockville, Maryland Department: Quality Job Code: QU24US # of openings: 1
Description
Quality Specialist I - Biologics
Position Objective The QA Specialist is responsible for oversight of Quality - Testing compliance issues.
Essential Functions: • Review assay data, protocols, reports, technical specifications, RIRs, pH / Osmos sheets • Review batch records and other documents for auditing requirements • Conducts assay systems and in-process inspections • Reviews SOPs/other documents for compliance requirements • Demonstrates verifiable turnaround times • Other GLP/GMP duties as assigned
Additional Function Details: 1-Comebacks/Mailing: This involves the administrative processing through BRIQS to generate QA Statements upon audit completion 2-Attending variety of Huddles and Meetings (wkly team meeting, monthly QA meeting, process improvements for TAT, to coordinate task coverage and study priorities, align best practices, trouble shoot and to identify unique customer needs (e.g., qualification/filtration requirements). 3-System/Process Inspections (Regulatory Requirement) conducts quarterly for four procedural phases, time intensive to follow up and resolve observations/findings; also involves review of binders for dilution schemes, logs for materials and cleaning, virus titers/recertifications, compliance w/training record requirements.
Nature and Scope: Performs a variety of quality system activities as assigned. Is familiar with regulatory requirements
Education: BS degree in a life science
Experience: A minimum of 0-2 years experience in Quality Assurance in a GMP or GLP environment.
Contacts: Has contact with all levels of company employees as well as interaction with company subcontractors/vendors and with customers.
Working Conditions: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing this job, specifically during audits/inspections, the employee will be exposed to moving mechanical equipment, harsh and/or toxic chemicals and biologicals, low levels of radiation and extreme cold (-70C). Noise level in some areas can exceed 100 decibels. Overtime may be required.
