QA Specialist IV
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.1
Reclaim your time by letting our AI handle the grunt work of job searching.
We continuously scan millions of openings to find your top matches.
Overview
Job Description
QA Specialist IVIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionWorks in the External Biological QA team of Shire United States (US) Quality Assurance supporting, packing and labeling operations, batch release, warehouse operations and logistics performed
The QA Specialist is responsible for support of appropriate procedures and policies for batch record review and product disposition according to the relevant regional regulations
Responsible for adhering to domestic and international GMP regulations, cGMP's, company policies, and BRAVE values.Responsibilities-This position is responsible for monitoring and supporting batch disposition of bulk drug products (DP) and finished drug products (FDP)The individual may be responsible for, but is not limited to: Conducting record review of executed batch records for finish drug products to support CMO packaging & labeling record review
Performing review of bulk drug product executed records, if needed
Prepares all paper work for product disposition (bulk and finished product) and performed assessments for impact to disposition from deviations and change controls
Reviews and approve deviations and change controls related to DP and FDPMay own CAPAs associated within the QA unit
Supports drug product and finish drug product annual review report sections
Understanding of GMP'sSupports departmental projects as needed
QualificationsBachelor's degree in chemistry, biology or a related discipline6-8 years Quality Assurance experience supporting the manufacture and/or release of drugs, biologics, or devices at CMOsWorking knowledge of DP and FDP batch record review
Understanding of quality systems and cGMPs.Interpersonal skills and professional skills to interact with customers
Must be flexible
Must be able to prioritize and multitask in a stressful environment
Fluency in English is required
Significant experience in parenteral biotech manufacturing (aseptic or sterile processing)Significant experience working with suppliers and/or contract manufacturing organizations
Experience with TrackWise and LIMS systems
Experience with packaging and labeling operations
Evaluation of batches to ensure completeness, accuracy and compliance
Evaluation of manufacturing or operational issues for impact and communication to management.Additional InformationRegardsRickyI'm interested
Automate your job search with Sonara.
Submit 10x as many applications with less effort than one manual application.
