- Legend Biotech USA, Inc. (Raritan, NJ)
- …shifts) as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Investigations Lead has the responsibilities for providing quality ... the treatment of multiple myeloma.Legend Biotech is seeking a QA Investigations Lead (1st or...experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …required. Advanced degree preferred.A minimum of 5 years of operations or quality Assurance experience within a cGMP environment in the biotech/biopharma ... to close nonconformance records and identify necessary corrections.Key Responsibilities Lead cross functional investigations independently from end to… 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 ... standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations /OOS/OOT/Lab Event,… 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 ... for identified continuous improvement efforts associated with the manufacturing site. Lead assigned Quality tasks associated with process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations , Corrections, and QMS records.Build the Site Readiness of MES ... be part of Manufacturing Excellence team reporting to the Manufacturing Execution Systems Lead and will be responsible for EBR development and administration at the… more
- Cook Medical (Pittsburgh, PA)
- …performance objectives for the department. The Team Lead works closely with QA Management to ensure investigations are completed in a compliant and timely ... and execute short-term and long-term development plans. The Team Lead , Investigations is responsible for leading the... discussion meetings as subject matter expert* Conducts deviation investigations in compliance with Cook Myosite quality … more
- Lilly (Durham, NC)
- …business objectives are met. The QA Product Complaints individual represents Quality Assurance on projects, including lean initiatives. Finally, the QA ... / Deliverables:** + Technical knowledge of complaint handling and/or quality systems + Support the QA Compliance...Compile and present complaint data for process teams, Site Quality Lead Team, and Process Flow team.… more
- HAECO (Lake City, FL)
- Quality Assurance Auditor ( QA -LCQ) Lake... investigations as assigned by the Manager of Quality Assurance . 4. Conduct periodic audits of receiving ... Tuition Reimbursements + Collaborative and Safe Work Environment **Position Overview** The Quality Assurance Auditor conducts internal audits at the HAECO… more
- Safran (Sarasota, FL)
- …efforts. * Product Maintenance: o Collaborate with cross-functional teams including design, quality assurance , supply chain, programs and customer support, to ... minimizing disruption to customers and stakeholders. * Root Cause Analysis: o Lead investigations into complex technical issues, conducting and documenting… more
- Citigroup (New York, NY)
- …in overseeing complex data environments, including experience with controls, monitoring, and quality assurance functions. + Deep understanding of data retrieval ... technologies to meet regulatory compliance and facilitate downstream discovery and investigations . **Key Responsibilities** : + Lead the execution of… more
- Catalent Pharma Solutions (Madison, WI)
- …network, Catalent Biologics is positioned to drive significant growth for Catalent. The Quality Assurance department is responsible for all aspects of the ... quality assurance functions at Catalent, Madison. The...as necessary, professionally and accurately. + Ability to independently lead investigations , deviations and change controls and… more
- Quality Consulting Group (Juncos, PR)
- …+ Approve planned incidents. + Represent QA on NPI team. + Lead investigations . + Lead site audits. + Own site quality program procedures. + Designee ... QUALITY CONSULTING GROUP, a leader in the pharmaceutical,...ability to interact with regulatory agencies. + Approve NC investigations and CAPA records. + Approve change controls. +… more
- City of New York (New York, NY)
- …clearance results. - Responsible for the maintenance of confidential records for all investigations performed. - Perform quality assurance review of ... covers a broad range of subject matter, including oversight of environmental investigations , lead poisoning, injury prevention, occupational health, food safety,… more
- ICON Clinical Research (Salt Lake City, UT)
- Quality Assurance Auditor II - US,...host Sponsor audits & Regulatory Inspections of ICON * * Lead investigations , root cause analysis (RCA) and ... to join us on our mission to shape the future of clinical development. Quality Assurance II Roles and Responsibilities: * Perform tasks relevant to the assigned … more
- Actalent (Foster City, CA)
- Job Title: Quality Assurance SpecialistJob Description We are seeking a dedicated Quality Assurance Specialist to manage and investigate product ... teams and Contract Manufacturing Organizations (CMOs), primarily via email. + Quality assurance expertise. Additional Skills & Qualifications + 2-4… more
- IQVIA (Durham, NC)
- …for continuous process improvements. + Assist in training of new Quality Assurance staff. + Support in QA initiatives/projects for quality , process ... By joining us as a **Senior** ** QA Auditor,** you will support global investigations...field. + At least 5 years experience in GCP Quality Assurance within pharmaceutical, technical, or related… more
- Kelly Services (Columbus, OH)
- …in the heart of Columbus, OH and 100% onsite. **Job Title:** Senior QA Specialist, QA Investigations /CAPA **Location:** Columbus, OH **Rate:** $35/hr. ... + Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments. + Performs the function of… more
- CSL Behring (Kankakee, IL)
- …Execute root cause analysis around equipment and operational events, owning change controls, investigations - Lead investigations as the subject matter expert ... control drawings, flow diagrams and Standard Operational documents.- Perform inspections for quality assurance on a periodic basis and initiate any procedures… more
