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Clinical Compliance Specialist

Integrated Resources, Inc

Pennsylvania

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Biology, Biotech and Pharmaceutical, Chemistry, Clinical Research, Clinical Trial, Communication Skills, Contract Analysis, Contract Manufacturing, Drug Development, Drug Products, GMP (Good Manufacturing Practices), Information Technology & Information Systems, Investigative Reports, Laboratory, Maintain Compliance, Manufacturing, Medical Products, Pharmacy, Product Development, Quality Assurance, Rehabilitation Nursing
LOCATION
Pennsylvania
POSTED
2 days ago
Clinical Compliance SpecialistA 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 Description• To provide QA support for work performed at contract manufacturers and analytical laboratories for primarily for developmental/clinical use.• To provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP.• To perform GMP release of IMP and ensure compliant release to other global markets as appropriate.• To communicate with contractors/suppliers regarding technical information and queries.• Ensure deviations/OOS are adequately investigated and documented.• Ensure clinical complaints are adequately investigated and reported.• To provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP and IND/CTA requirements.• Review and approve Master records, labels and protocols.• Actively participate in project meetings as required.Qualifications• To be knowledgeable about the products supplied for clinical trials.• University degree or equivalent in Chemistry, Biology, Pharmacy or other relevant science or an equivalent combination of education and experience – required• Practical Experience of at least 4 years in a QA environment in the pharmaceutical industry – required.• Practical clinical manufacturing/packaging environment experience – required• Good understanding of GMP's within a global environment – required• Good understanding of Clinical Trial Manufacturing – required• Good understanding of API manufacturing – preferred.• Good technical and QA background having a good understanding of method development and validation, specification setting.• Communicate effectively with contractors for technical information.• Good technical and QA background having a good understanding of drug product development.• Disposition certify and release IMP as required ensuring compliance• Global QA• Global Pharmaceutical Technology.• Global Pharmaceutical Sciences (Product development and clinical supplies)

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Integrated Resources, Inc

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