QA Specialist IV

Integrated Resources, Inc

Lexington, Massachusetts

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Asepsis, Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Clinical Research, Contract Manufacturing, Corporate Policies, Current Good Manufacturing Practice (cGMP), Drug Products, English Language, Establish Priorities, GMP (Good Manufacturing Practices), Information Technology & Information Systems, Interpersonal Skills, Laboratory Information Management System (LIMS), Logistics, Manufacturing, Manufacturing Operations, Multitasking, Product Reviews, Product Support, Quality Assurance, Regulations, Rehabilitation Nursing, Warehousing

LOCATION

Lexington, Massachusetts

POSTED

1 day ago

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 performedThe QA Specialist is responsible for support of appropriate procedures and policies for batch record review and product disposition according to the relevant regional regulationsResponsible 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 reviewPerforming review of bulk drug product executed records, if neededPrepares all paper work for product disposition (bulk and finished product) and performed assessments for impact to disposition from deviations and change controlsReviews and approve deviations and change controls related to DP and FDPMay own CAPAs associated within the QA unitSupports drug product and finish drug product annual review report sectionsUnderstanding of GMP'sSupports departmental projects as neededQualificationsBachelor'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 reviewUnderstanding of quality systems and cGMPs.Interpersonal skills and professional skills to interact with customersMust be flexibleMust be able to prioritize and multitask in a stressful environmentFluency in English is requiredSignificant experience in parenteral biotech manufacturing (aseptic or sterile processing)Significant experience working with suppliers and/or contract manufacturing organizationsExperience with TrackWise and LIMS systemsExperience with packaging and labeling operationsEvaluation of batches to ensure completeness, accuracy and complianceEvaluation of manufacturing or operational issues for impact and communication to management.Additional InformationRegardsRickyI'm interested

QA Specialist IV

Integrated Resources, Inc

Lexington, Massachusetts

About the Company

Integrated Resources, Inc

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