Gulbrandsen Technologies

PRINCIPAL PURPOSE OF JOB: Develop and maintain all aspects of Quality Assurance for both GCI-SC and GTI-SC at Orangeburg plant site.. Responsible for performing inspections, batch record review and quality system functions in accordance with cGMP and related company SOP's, state, federal and local laws as applicable.. Ensure that Lab / Production equipment is calibrated as per the Calibration planner.. Bachelor’s degree in a scientific discipline and at least 7 years of Quality/cGMP experience in the API/Pharma industry. Prior chemical plant experience preferred

quality assurance specialist

REPORTS TO: Global GM - Quality Management & Compliance PRINCIPAL PURPOSE OF JOB: Develop and maintain all aspects of Quality Assurance for both GCI-SC and GTI-SC at Orangeburg plant site. LEVEL OF AUTHORITY: Performs duties with minimal supervision and defined latitude for independent judgment within established guidelines and policies. WORK ENVIRONMENT: Most work will be performed indoors in an office environment with some work performed within the plant and lab facilities. ESSENTIAL JOB FUNCTIONS<ul><li>Ensures compliance with cGMP and internal policies, procedures, and specifications</li><li>Responsible for performing inspections, batch record review and quality system functions in accordance with cGMP and related company SOP's, state, federal and local laws as applicable.</li><li>Track controlled documents through the issuance of Document Control numbers, logbooks, change requests, and document status reports</li><li>Provide new hire training on cGMP using ICH 7Q guidelines and maintain the training program documentation.</li><li>Ensure standard operating procedures are periodically reviewed for relevance and accuracy in compliance with company policies and procedures.</li><li>Ensuring all documents are up to date with respect to version control and issuance</li><li>Perform and support maintenance and closure activities of documents such as reports, CAPAs, change controls, and complaints.</li><li>Ensure that deviations (Internal TAMEs) are recorded and investigated in a timely manner.</li><li>Ensure that Lab / Production equipment is calibrated as per the Calibration planner.</li><li>Ensure that Lab Records are documented following Good Documentation Practices (GDP) underlying ALCOA principles (Attributable, Legible, Contemporaneous, Original & Accurate)</li><li>Ensure that manufacturing and lab records are complete and retrievable.</li></ul> QUALIFICATIONS<ul><li>Should be knowledgeable of cGMP requirements, FDA regulations, and ICH 7Q guidelines.</li><li>Bachelor’s degree in a scientific discipline and at least 7 years of Quality/cGMP experience in the API/Pharma industry</li><li>Experience supporting regulatory/Customer audits followed by remedial measures post audit</li><li>Prior chemical plant experience preferred</li><li>Must have good interpersonal and communication skills.</li></ul>

START NEW SEARCH