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Quality Specialist II - Biologics US
Job Number:
25715553
Company Name:
BioReliance
Job Location:
Rockville, MD US
Job Category:
Healthcare & Medical
Quality Specialist II - Biologics US
Quality Specialist II - Biologics US Location: Rockville, Maryland Department: Quality Job Code: QU25US # of openings: 1
Description
Quality Specialist II - Biologics
Position Objective The QA Specialist II is responsible for oversight of Quality - Testing compliance issues.
Essential Functions: • Review assay data, protocols, reports, technical specifications, RIRs • Review batch records and other documents for auditing requirements • Conducts assay systems and in-process inspections • Trains other QA auditors as a Qualified Trainer • Audits custom assays • Reviews SOPs/other documents for compliance requirements • Reviews validation protocols and reports • Works with Operations Groups to implement procedures to improve data accuracy • 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. 4-Critical document Review to reconcile/align documents (Protocols, batch records, SOPs) up for 2-yr review, revised, harmonized or new. . 5-Training (at least 1x/quarterly or more as needed): Cross training other auditors and interns, training when new assays introduced
Nature and Scope: Takes independent ownership of specific quality system aspects. Is capable of making decisions and representing quality in cross functional settings. Is capable of cross training others in the area. May be relied upon to provide regulatory guidance in specific areas. Has regulatory knowledge in defined areas.
Education: BS degree in a life science
Experience: A minimum of 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.
