- Aequor (Thousand Oaks, CA)
- …Sr. Associate Quality Assurance position supports 's Quality Assurance program under the Plant QA organization providing daily oversight of the Drug ... on the manufacturing floor, inc. Inspection support, ASP and QA assessments, Electronic batch record review, SOP revision approval,...functional area quality for the Drug Product Quality Assurance department in the execution of… 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 QA role on the manufacturing floor and the remaining...this vital role, will be responsible for PQA (Plant Quality Assurance ) On the Floor in support… 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 ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and focus on the delivery and execution of non-project initiatives within R&D Quality and Global RD/PV QA by collaborating with business process owners ... on applicable Global QA processes and quality standards for continuous improvement and operations excellence. This may include the review of business partner… more
- BioAgilytix (Durham, NC)
- …then you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPerforms Quality Assurance ( QA ) audits, inspections (internal/external), and ... role/operations Not less than two (2) years' experience in GLP/GCLP quality assurance ( QA )Experience working in biotech, pharmaceutical, CRO/CMO or similar… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position SummaryThe Quality Director is the senior leader and decision maker for the Quality Department and Quality Management System. This position is ... ultimately responsible for the product quality received by the customer and the quality system integrity expected by the customer. The Quality Director is… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …provides direct support for all finishing manufacturing activities. This position supports the Quality Systems within the Quality Assurance Unit ensuring ... Good Manufacturing Practice (cGMP) for in process manufacturing pharmaceuticals. Provides Quality Assurance support for all manufacturing activities performed… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …must have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Supervisor as part of the Quality... QA Investigations Supervisor as part of the Quality team based in Raritan, NJ. Role OverviewThe … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... in the treatment of multiple myeloma.Legend Biotech is seeking QA , Document Control Specialist (1st Shift) as part of...Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Specialist (1st shift) role is an… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …SQE Manager, QA Compliance, is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring ... with all CFR, USP, cGMPs, and SOPs. SQE Manager, QA Compliance will rely on experience and judgment to...to plan and accomplish goals specific to the Supplier Quality Program. This position supports the ongoing development and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Executive Administrative Assistant to provide comprehensive support to leaders and members of GMP Quality Assurance team and will serve as the primary point of ... for someone with pharmaceutical industry experience supporting senior leaders within Quality or related function.Proficiency in Microsoft Office Suite (Word, Excel,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …supporting and participating in regulatory agency inspections, partner audits, and QA inspections preferred- Veeva Quality Docs Vault, Valgenisis, Trackwise ... improvements and workflow efficiencies. The GSM works closely with QA during regulatory agency, partner, and internal audits and...on the global performance of owned processes. Monitor Service Quality and put proactive measures in place to improve… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Specialist, Quality Assurance 2nd Shift - Our Company constructed a new manufacturing facility to significantly expand its ... lyophilization, product inspection, and quality control laboratories. - The Quality Assurance Specialist will support this expansion. Project activities… more
- Tris Pharma (Monmouth Junction, NJ)
- …Summary:The Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance ( QA ) Investigations and Product Quality ... Improvements (CPIs)Works directly and cross functionally throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and resolve basic to moderate operating difficultiesCollect required samples needed for Quality Assurance testing as requiredPerform line changeovers in a safe ... of the production lineComplete all required documentation and scheduled quality checksEnsure adequate supply, function, and output of production equipmentAdjust… more
- Merck & Co. (Rahway, NJ)
- …Final Study Report Maintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed of the study ... and scientific contacts and key opinion leaders in relevant fields.Conduct quality control inspections of study protocol, study documentation files and reports.… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …plans for staffAssist in the performance of Media Fills with input from Quality Assurance , Validations, and Operations This position may be involved with ... assist leadership in building, leading and developing a group of quality control microbiologists that support the ongoing development, manufacture, and distribution… more
- Merck & Co. (Durham, NC)
- …experienceAseptic Gowning knowledge and techniquePrevious shop floor quality , quality control or quality assurance experienceExperience with ... assignments to support business needs. Primary Responsibilities: Member of the Quality Sterility Assurance team, providing support to ensure compliance… more
- AUROBINDO (Dayton, OH)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... or related scientific discipline.Up to 2 years experience in pharmaceuticals Quality control Laboratory. Physical RequirementsLAB TECHNICIANS - Must be able to… 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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