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Experience with Veeva (Quality Docs, QMS and Training modules) a plus. Global Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expandingLooking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization.
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Manufacturing quality technician. Employee is responsible to follow and uphold all Food Safety, Food Quality, Occupational Safety, Health and Environment policies and procedures as pertains to role.
$25 - $31.12 an hourFull-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
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The CMC Regulatory Technical Writer II authors high quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports. A background of pharmaceutical manufacturing or quality control/quality assurance is a plus.
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Internal Partners: Planning, Quality Engineering and Product Support. QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.
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3-5 years of experience in drug safety, pharmacovigilance, quality assurance, or a related field. Provide drug safety and pharmacovigilance leadership to the quality and compliance team, fostering a culture of collaboration, excellence, and continuous learning.
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The Quality Assurance Manager will work under the direction of the Quality Assurance Director to perform the required quality assurance inspections on utility scale PV systems. Responsible for verifying quality of work based on drawings, code compliance, submittals, and product manuals.
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Position requires on-site presence at companies' HQ Essential Duties and Responsibilities Conducting Training: Developing and conducting training programs for personnel on GMP and GDP requirements, quality systems, and relevant procedures to ensure understanding and compliance throughout the organization.
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Developing and Maintaining Quality Systems: Establishing and maintaining comprehensive quality systems in compliance with GMP and GDP regulations. Continuous Improvement Initiatives: Leading or participating in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes, driving a culture of quality and excellence within the organization.
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Quality Lab Inspections. The key focus is on GBP Lab procedures, sample management and chain of custody, sample inspections, and reports. Product Packaging Inspection and Forensic Analysis (no chemical forensic analysis.
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8+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC. Hands-on experience with designing and implementing GMP Quality Systems.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Certification in Quality Management (e.g., Certified Quality Auditor, Certified Quality Engineer) may be beneficial. 2 years or more in Experience in a Quality functional area, i.e. Quality Systems, Quality Management etc.
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He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. Job Title: Technical Writer II (Manufacturing/Quality.
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Worker manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. Title: Technical Writer II (Manufacturing/Quality) 1st Shift.
$50 an hourExpandApply NowActive JobUpdated 8 days ago - UpvoteDownvoteShare Job
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Apply appropriate Quality Engineering and PEx tools (e.g. PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) ASQ Certifications for Certified Quality Engineer (CQE), Quality Manager (CQM), and/or Supplier Quality Professional (CSQP.
$121,900 a yearFull-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
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10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC. Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches.
$210,000 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago
Title: quality Company: Direct Line Global in Whitehouse Station, NJ
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