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Complete all work in compliance with established cGMP, FDA, OSHA, USDA, EPA, ISO and Quality System regulations, as applicable, to assure output meets established quality and regulatory specifications.
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The Associate Quality Systems Specialist will be part of the Quality team and responsible for providing quality support for the site quality management system. Bachelor’s degree in any life science, GMP, Pharma industry experience At least 1 year of experience 100% on-site Ideal candidate has reviewed docs in a GMP setting or worked in a quality role in a GMP setting.
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Roles that are responsible for the analysis, development, and operation of quality and risk management systems. Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies.
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The Quality Assurance Expert will conduct analytics to ensure that the company's products are according to defined quality standards. Activities include developing standards for quality, documentation, and processes as well as continuous improvement and preventive activities.
$28 - $30 an hourExpandUpdated 5 days ago - UpvoteDownvoteShare Job
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Responsible for the analysis, development, and operation of quality and risk management systems. The position prepares Quality System documents and reports as needed for Rocklin site metrics and management review.
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Conducts analytics to ensure that the company's products are according to defined quality standards. BEPC has an open position for a Quality Assurance Expert I. The position may represent Quality on cross-functional teams to support business needs driving a positive site quality culture.
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Directly responsible for ensuring documents submitted to Quality are compliant to company procedures, regulatory requirements, and the quality manual. Collaborates and coordinates with internal stakeholders to identify, escalate, and resolve quality issues.
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Electronically signs as a technical approver for quality on applicable documents and within the validated electronic databases. Review and approve quality documentation and records. Understands and follows the requirements of the quality system.
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Associate Quality Systems Specialist. Electronically signs as technical approver for quality on applicable documents and within the validated electronic databases. Post-Market Surveillance plans and reports.
$24 - $26 an hourFull-timeExpandApply NowActive JobUpdated 23 days ago - UpvoteDownvoteShare Job
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This Associate Quality Systems Specialist position is multi-disciplinary with opportunities to work on future products and current product and process improvements. Organization: Typically reports to a Manager role or Project Manager role (for a defined period of time) based on organizational set-up, will have a lead person for day-to-day guidance.
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Skills: Quality Assurance, GMP (Good Manufacturing Practice) Preferred: Bachelor's degree in any life science, GMP, Pharma industry experience. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals.
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Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates. Provide QA support to enforce CQV guidelines, policies and procedures for equipment, analytical equipment, utilities, and facilities (Examples: Chromatography Systems, harvest hold tank, Lyophilizers, washers, autoclaves, gas distribution system, HVAC, etc.
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Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems.
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Quality/Compliance - Adherence to CMTI Quality systems/cGMP •Delivery - ensuring a timely flow and completion of micronization and milling jobs •Cost - Ensure base cost and inventory management, process efficiency and resource utilization.
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Interact with manufacturing management to provide quality perspective on routine operations and support systems. Compile and review raw data, batch records and test results, including Final Reports and CoA’s, in accordance with cGMP.
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