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QA/QC Specialist I

Integrated Resources, Inc

Lexington, Massachusetts

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Analysis Skills, Biology, Biotech and Pharmaceutical, Chemistry, Clinical Research, Clinical Support, Clinical Trial, FDA Requirements, GMP (Good Manufacturing Practices), Information Technology & Information Systems, Maintain Compliance, Manufacturing, Medical Products, Pharmacy, Quality Assurance, Quality Control, Regulatory Compliance, Rehabilitation Nursing, Standard Operating Procedures (SOP), Support Documentation, Time Management
LOCATION
Lexington, Massachusetts
POSTED
3 days ago
QA/QC Specialist IA 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 DescriptionPosition Details:Location Lexington, MAJob Title QA/QC Specialist 1Duration 6+ MonthsJob Function and Description:To provide QA support for the manufacture, packaging and control of clinical trial materials to ensure compliance with GMP and perform GMP release of IMP and to ensure compliance with market regulations.Responsibilities• To provide QA support for the manufacturing, packaging and control of clinical trial materials to ensure compliance with GMP and CTA requirements.• Actively participate in project meetings as required.• To be knowledgeable about the products supplied for clinical trials.• Ensure complaints and deviations are fully investigated and documented. Release supplies in CSMD where appropriate.• Ensure that all appropriate batch related documents are available in order to release the products.• To communicate with contractors/suppliers regarding technical information and queries.• Ensure the documentation systems to support Clinical QA Release activities are maintained.• Prepare and/or update standard operating procedures and to ensure all Clinical QA SOP's are reviewed in a timely manner.• Ensure that GMP training is current and completed on time.Education and Experience Requirements• Degree or equivalent in Chemistry, Biology, Pharmacy or other relevant sciences.• Practical experience of at least1 years in a QA environment in the pharmaceutical industry (in a clinical manufacturing/packaging environment preferred)• Practical analytical experience desired.• Good understanding of GMP regulations (FDA, EU, JP, etc.)

About the Company

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Integrated Resources, Inc