Quality control manager

Integrated Resources, Inc

Cambridge, Massachusetts

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JOB DETAILS

JOB TYPE

Contractor

SKILLS

Analysis Skills, Analytical Chemistry, Analytical Method Development, Analytical Method Validation, Assay Methods, Assays, Biology, Biotech and Pharmaceutical, Chromatography, Clinical Research, Communication Skills, Contract Analysis, Creative Writing, Employee Orientation, Healthcare, Inductively Coupled Plasma Mass Spectrometry (ICP-MS), Information Technology & Information Systems, Laboratory, Leadership, People Management, Performance Analysis, Quality Assurance Methodology, Quality Control, Quality Management, Regulations, Rehabilitation Nursing, Small Molecules, Testing, The Joint Commission (TJC)

LOCATION

Cambridge, Massachusetts

POSTED

1 day ago

Quality Control ManagerA Few Words About Us - Integrated 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 DescriptionOur Client is looking for Quality Control Manager-with Small molecules, validation, analytical chemistry, methods validations etc. experience…..!!!!!Summary: Manage Small Molecules/Oral Solid Dosage analytical test methods validations and transfers for release and stability testing of commercial pharmaceutical products.Manage complex scientific knowledge of analytical methods and updates. Manage a staff of qualified scientific employees and provide guidance in the area of expertise.RESPONSIBILITIES:Method design (re-design) and validation (re-validation)Method performance monitoring (trending), control and troubleshootingMethods transfer working with internal and contract sitesAuthor analytical regulatory sections and response to questionsWork with interconnected departments and other groups in Pharmaceutical OperationsAnalytical expert for assay optimization, validation and transferPresent analytical issues and findings to senior managementQualificationsQUALIFICATIONS AND SKILLS NEEDED:• A bachelor's degree in analytical chemistry with 5+ years or a Master's with 3+ years of leadership and experience in a pharmaceutical/biotechnology industry.• Experience directing activities related to analytical method development, qualification and validation of Small Molecules, Oral Solid Dosage assays, method performance monitoring, methods transfer and working with external laboratories.• Experience with regulatory writing of analytical sections and response to questions• Excellent communicator, author and creative thinker with extensive knowledge in the area of expertise• Specific techniques include chromatography, particle size, XRPD, Dissolution and Disintegration, ICP-MS, KF and compendia methods• Excellent project and people manager who can motivate, direct projects, and align scientificAdditional InformationRegardsPooja MishraClinical RecruiterIntegrated Resources, Inc.IT Life Sciences Allied Healthcare CROCertified MBE |GSA - Schedule 66 I GSA - Schedule 621ITel: 732 429 1636(W) 732-549-2030 x 214 | (F) 732-549-5549Gold Seal JCAHO Certified for Health Care Staffing"INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES" (8th Year in a Row)

About the Company

Integrated Resources, Inc

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Quality control manager

Integrated Resources, Inc

Cambridge, Massachusetts

About the Company

Integrated Resources, Inc

Resume Resources

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