QUALITY ANALYSTS
KATALYST HEALTHCARES & LIFE SCIENCES INC.
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At a glance
Requirements
Credentials this posting asks for.
Job overview
KATALYST HEALTHCARES & LIFE SCIENCES INC. is hiring a QUALITY ANALYSTS. The role involves design, development, implementation, testing, documentation and support of cGxP systems per 21CFR Part11 and US FDA, including qualification and validation, master plans, protocols, change requests, gap and root cause analysis, risk management, traceability, and summary reports for facilities, equipment, systems and processes.
Key focus areas include Design, develop, implement, test, document, and support cGxP systems, Perform qualification and validation (IQ/OQ/PQ) activities, and Create master plans, protocols, and change requests.
Important skills include cGxP Systems, 21CFR Part11, US FDA, Qualification & Validation (IQ/OQ/PQ), Risk Management Plans, and Traceability Matrix.
Skills & qualifications
Skills
Qualifications
Full job description
Experience Required
6 Months
Minimum Education Required
Master's degree
Compensation
$98,571.00 - $98,571.00 / Yearly
Hours Per Week
40
Number Of Positions
5
Shift
First Shift (Day)
Job Description
Involve in the design, development, implementation, testing, documentation & support of cGxP systems as per 21CFR Part11 & US FDA. Responsible for qualification & validation (IQ/OQ/PQ), master plans, protocols, changes requests, gap & root cause analysis, risk management plans, traceability matrix, summary reports for facilities, equipment, systems & processes. Preparation, review, authorize & submission of documentation for quality compliance & regulatory authorities. Master's degree in Science, Engineering, Pharmacy, Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Mechanical Engineering, Industrial Engineering, Regulatory Affairs, Public Health, or related field along with six months of experience in the job offered or related occupation is required. Work location: South Plainfield, NJ and various unanticipated locations throughout the U.S.
Email Resume to HR Dept., Katalyst Healthcares & Life Sciences, Inc., at [email protected].
Place of Work
On-site
Requisition ID
QE-559
Job Type
Full Time
Application Email
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