- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …partners to ensure a culture of compliance at all levels.Create and maintain project management methodologies. Support the global GMP quality annual objectives, ... affiliates and DS HQ's in order to ensure the quality of drug products marketed globally and acts as...GMP Compliance team's participation in local, regional, and global project teams. Provides direction and consultation services for global… more
- Catalent (Philadelphia, PA)
- …in Philadelphia, PA is hiring a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors on the production floor, ... incoming material quality , and/or distribution quality , including quality oversight for material management...packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document ... packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... updating relevant Trial Master Files (TMF) with CSO-related documentsSupports the CSO Project Mgmt Lead in executing additional operational and logistical duties… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of best practices and lessons learned. This role will also work with R&D Quality Assurance (R&D QA) and the respective operational functions to identify areas ... in pharmaceutical or biotechnology in clinical trial operations or clinical quality assurance . required Experience Qualifications4 or More Years Strong… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and compliance standards in the healthcare and digital health space. Establish quality assurance processes and protocols to support implementation Budget ... business challenges Strategic Planning, Execution and follow-through skills required Strong project management skills to lead and oversee multiple initiatives… more
- Aequor (Thousand Oaks, CA)
- …required about 1 week a month - multiple short trips. In support of 's Quality Assurance program manages and oversees the operations of a specific area(s) of ... Environmental Characterization reports) Approve planned incidents) Represent QA on NPI team) Lead investigations) Lead plant audits, participate in site audits)… more
- Aequor (Devers, TX)
- …Schedule: Mon - Fri, First shift (8:30AM - 5PM)Job Description/ Responsibilities: Provides Quality Assurance (QA) support to Devens Site and reporting Manger ... through quality review and approval of Investigations and Corrective Actions....ISPE. Prior experience of QC equipment Qualification and some project management experience Knowledge of biotech, bulk drug substance… more
- Careerbuilder-US (Johnstown, OH)
- …of new products and process platforms from R&D into the current manufacturing environment. . Quality Assurance : Ensure product quality through the design of ... between teams and departments to optimize setup, reduce changeover times, and enhance quality . . CAD Projects : Generate CAD drawings for new projects and update… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expertise and solutions to CSV questions and issues.Responsibilities- Provide Validation Lead support for Daiichi Sankyo GxP and Non-GxP computer systems ... for CSV projects. Work within a risk-based framework (Computer Software Assurance (CSA)) that is compliant with global regulatory expectations and business… more
- Eisai, Inc (Nutley, NJ)
- …incidents.Conduct annual tests and address vulnerabilities.Analyze threat data and lead hunting efforts.Deploy standards, conduct training, and track KPIs.Define ... daily coaching and mentoring to staff (direct reports and project teams). Manage direct reports including recruitment, supervision, scheduling, development,… more
- Southwest Research Institute (San Antonio, TX)
- …department QA staff, project engineers, and management.Create and deliver quality assurance presentations.Conduct training on program/ project /system ... quality assurance engineering procedures at both the program and project levels. Daily and Monthly Responsibilities: Lead the implementation of, and… more
- Aequor (Thousand Oaks, CA)
- …by outsourced/contract verification staff. Act as a liaison between engineering and quality assurance during project planning, execution, and closeout ... regulatory inspections Participate in internal audits and assess in conjunction with quality assurance Assist in developing and maintaining business metric… more
- Merck & Co. (Durham, NC)
- …upkeep of new and existing MES environments in accordance with Computer Software Assurance (CSA) Lead the definition, SDLC documentation and validation of new ... work in our manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work...and embracing an empowered team culture.The Sr. Specialist will lead a small elite team of like-minded Subject Matter… more
- Eisai, Inc (Nutley, NJ)
- …confirmation for all key commitments including scope and requirements changes , quality assurance plans, budget s , and implementation schedules. Approve ... best practices. Advises on SaaS support and conversion . Project Management (25% of Time ) Lead ...consistently demonstrat es Eisai 's core company values : Quality , Teamwork , Respect, Integrity, and Professionalism. Desirable Knowledge… more
- Aequor (Thousand Oaks, CA)
- …leadership, International Quality , Quality Control, Contract Manufacturing Quality , Regulatory, Process Development, Quality Assurance , and other ... (referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ)...responses to questions. The individual is directly responsible to lead a Product Quality Team (PQT), including… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …key functions (eg clinical research & development, clinical science, clinical quality assurance , project management) Preferred requiredStrong leadership, ... partners to support GCO risks. This individual will also lead and manage the GCO CTOR and Strategic Vendor...risks.Manage and oversee the CTOR team who support GCO Quality by Design, risk and issue management. This team… more
- American Honda Motor Co Inc (Marysville, OH)
- …as well as New Model, Procurement, and Supplier Assurance to drive supplier characteristic improvement.Responsibilities include:Support supplier improvement ... report on, and escalate suppliers that are not capable of meeting project milestones within the timeframe established.Evaluate NARS reports (A-Rank, mislabel, etc)… more
- Merck & Co. (North Wales, PA)
- …We are Looking for: Minimum:-Bachelor's Degree in Regulatory Affairs, Quality Assurance , Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, ... attend educational sessions, and receive direction from our Veteran Talent Program Lead throughout the Fellowship. Our primary objective is to provide you with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functional areas (eg clinical research & development, clinical science, clinical quality assurance , project management) preferredStrong leadership, ... for the ownership and maintenance of GCO-owned procedural document packages. Lead authoring, review, and periodic reviews/updates for all GCO procedural… more
