- 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 of materials at Catalent-Philadelphia. Assist in… more
- Catalent (Philadelphia, PA)
- Quality Assurance Document Control Supervisor Position Summary Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Document ... Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and...committed to a Patient First culture through excellence in quality and compliance, and to the safety of every… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …support records to certify compliance with specifications and procedures Releases product based on Quality Assurance record review and approval by QA Manager ... EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience in pharmaceutical or biotechnology in clinical trial operations or clinical quality assurance . required Experience Qualifications4 or More ... around rare diseases and immune disorders. Summary The Manager, Clinical Quality Management (CQM), Inspection Readiness Lead...lessons learned. This role will also work with R&D Quality Assurance (R&D QA) and the respective… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... Summary This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas/process improvement to stakeholders via the QMS scheme (ie, Quality Management Review , Quality Review Board) across the global CSPV organization ... business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise...in close collaboration with the VP, Global head of Quality Assurance (RD/PV QA). CAPAs Ensure adequate… more
- Catalent (Philadelphia, PA)
- …other related scientific discipline or equivalent experience. 15 + years of Scientific or Quality Assurance in clinical trials packaging, in addition of ... Control, and Customer relations.The Role: Provides direction and guidance to the Quality Disposition, Materials Sampling Quality Assurance , Regulatory and… more
- Aequor (Thousand Oaks, CA)
- … Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance , Quality ... vital role, you will provide support to the Product Quality (PQ) organization as a subject matter expert of...Review , verify, report, and archive GMP data for clinical and commercial products Apply keen attention to detail… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …equivalent technical discipline is required A minimum of six (6) years of experience in Quality Assurance / Quality Systems or Compliance with a minimum of 4 ... compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP...team, ad hoc, for activities such as annual product review , site risk register, or internal quality … more
- Catalent (St. Petersburg, FL)
- …Catalent St. Petersburg site. The QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical documents ... QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's...across the site and with clients to drive timely review , approval, and closure of investigations, change controls, audit… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(eg clinical research & development, clinical science, clinical quality assurance , project management) preferredStrong leadership, collaboration, ... around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management, will be… more
- Dexian - DISYS (Rocklin, CA)
- Title- Quality Assurance Specialist Duration- 12+ months Location : Rocklin, CAPay range- $25-27/hr Preferred: Bachelors degree in any life science, GMP, Pharma ... to Quality are compliant to company procedures, regulatory requirements, and the quality manual. * Performs project review and audit of Device History Files… more
- Catalent (St. Petersburg, FL)
- …metrics, including DRB (Deviation Review Board) presentation.Effective communication with Quality Assurance Supervisor and Manager regarding status of daily ... I. Department Overview: The Quality Assurance Department is responsible for...organization, participating in internal assessments, routine compliance and CAPA review board meetings including follow-up actions and facilitate and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and supporting complaint and recall programs, . This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as ... expectations for products. The incumbent is responsible to adhere and maintain Quality Management System and GMP Compliance Programs to assure product quality… more
- Careerbuilder-US (El Segundo, CA)
- Job Title: Senior Quality Assurance Specialist - I Job Location: El Segundo, CA Job Duration: 6 Months (Possible extension) Pay range: $58/hr. on W2 Job ... * Perform Product Disposition and Lot Closure. Includes commercial and clinical products. * Review batch-related documentation and ensure resolution… more
- Catalent (St. Petersburg, FL)
- …and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. ... manufacturing challenges.Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer… more
- Merck & Co. (North Wales, PA)
- …Experience/Skills We are Looking for: Minimum:-Bachelor's Degree in Regulatory Affairs, Quality Assurance , Clinical Affairs, Pharmacovigilance, Biology, ... the preclinical space, RDH partners with functional leaders and teams within Digital Clinical Measures (DCM), Global Clinical Operations team (GCTO) and Business… more
- Aequor (New York, NY)
- …York State Prefer minimum of 1-3 years relevant experience in case management, utilization review and/or quality assurance Experience in acute episodic care, ... Position Purpose:Provide case management and clinical services to employees within their regulated scope of practice.Experience/Education: BA/BS in nursing degree… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate hasexperience working in an aseptic manufacturing facility, preferably in quality assurance ,manufacturing compliance, clinical quality , or ... of corrective and preventive actions, as necessary. Supports internal/external audits. Supports Quality risk assessment teams. Review /approve documents as a … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , ... Lead (2nd or 3rd shift) as part of the Quality team based in Raritan, NJ. Role Overview The...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
