- Aequor (West Greenwich, RI)
- …equivalent combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP ... pharmaceutical or medical device industry. Evaluate documentation and operation and documentation according to company guidelines. Be self motivated, attentive to details and able to prioritize and meet deadlines. Basic statistical mathematical skills… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …required.It is preferable that the candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing ... SOPs, work instructions.Develop positive relationship with the QA team, Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations ... and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance.Expertise in GMP compliance ... and controls systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance.Thorough knowledge and ... computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will be responsible in handling day-to-day activities… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …support for all finishing manufacturing activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring compliance ... current Good Manufacturing Practice (cGMP) for in process manufacturing pharmaceuticals. Provides Quality Assurance support for all manufacturing … more
- Aequor (West Greenwich, RI)
- …for this role? IE office based, lab based, manufacturing floor? This is plant quality assurance role, therefore the EW will spend 50-60% of their time in a ... making.Job Details: In this vital role, will be responsible for PQA (Plant Quality Assurance ) On the Floor in support of Manufacturing activities. This… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …by the FDA, EMEA or a leading international regulatory agency preferred Experience with Quality Assurance oversight and support for all phases of Clinical and ... certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …with an interdisciplinary team that includes but is not limited to quality assurance , quality control, operations, engineering, maintenance, calibration, ... safety, supplier quality , technical services, subject matter experts, and quality approvers to ensure appropriate and timely determination of scope, potential… more
- Aequor (West Greenwich, RI)
- …In this vital role, will be responsible for PQA (Plant Quality Assurance ) On the Floor in support of Manufacturing activities. This position requires ... tasks are completed Preferred Qualifications: Bachelor's degree and 2 years of Quality / Manufacturing work experience Experience working in a cGMP environment… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …the company. The Quality Director will oversee the health of the manufacturing processes through risk monitoring and oversee the conformance to the QMS through ... the day-to-day responsibilities and duties of personnel within the quality department.Perform manufacturing investigations, writing investigation reports, and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …investigations into microbiological and manufacturing process nonconformances.Assist Sterility Assurance and Quality management during routine audits by ... to coordinate project execution and to work alongside Sterility Assurance , Quality , and Operations personnel to ensure...regulatory agencies, pharma manufacturing partners and internal corporate auditors.Assist as a facility… more
- Aequor (Thousand Oaks, CA)
- …, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment. Understanding of biopharmaceutical bulk and drug product ... hours 8-5 Mon - Friday. Ideal candidate: Experience with quality management systems and 5&plus YOE. Nice to have:... manufacturing and distribution processes. General knowledge of cGMP and… more
- Merck & Co. (Rahway, NJ)
- …product, preferably an autoinjectorDemonstrated sound understanding of related fields (eg, manufacturing , process development, analytical, quality assurance ) ... the Director/Principal Scientist in Devices and Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device… more
- AUROBINDO (Durham, NC)
- …quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing , R&D, Quality Assurance and Quality control, and ... method development, validation, and technology transfer, with strong knowledge of manufacturing , analytical, and quality control processes. Skilled in… more
- Merck & Co. (Durham, NC)
- Job Description Job Description: Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, ... Demonstrated knowledge of GMPs, compliance issues, inspectional trends, industry quality assurance practices, and systems. Demonstrated innovative mindset.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is preferable that the candidate have 2 years + of experience working in Quality Assurance . Previous cell therapy experience is a plusKnowledge of cGMP ... compliance input for identified continuous improvement efforts associated with the manufacturing site.Lead assigned Quality tasks associated with process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …technical discipline is requiredA minimum of six (6) years of experience in Quality Assurance / Quality Systems or ComplianceExperience conducting internal ... the planning and execution of internal audits for all quality system areas for the manufacturing site;...for all quality system areas for the manufacturing site; write audit reports, issue audit observations and… more
- Merck & Co. (Millsboro, DE)
- … teams are the people that make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous ... improvement.- We work in the local/regional plants connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …packaging and labeling. This position will interface with Operations, Regulatory, Quality Assurance , Finance, R&D, Project Management and Quality ... coach cross functional team staff in areas such as quality , compliance, safety, project planning, process development, technology development.Communicate effectively… more
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