- 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)
- …review and drug product release practices.Develop positive relationships with the QA team, Quality Control, Information Technology, maintenance, Manufacturing ... Site Leadership Team members, and peers.Independently makes appropriate and compliant GMP decisions. Lead the establishment and improvement of QA practices to… 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
- 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 ... quality systems to include; Change Control, Deviations, CAPA's, Investigations and Audits.Plan and maintain spares and consumables for min-max and… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Operations, ). You will develop root cause analyses in the context of Quality Investigations (QI's). He/she supports CAPAs (Corrective and Preventive Actions) ... deployed and maintained following necessary GMP requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems… 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
- Pfizer (Collegeville, PA)
- …Regulatory Quality Assurance related to audit and inspection CAPA management ** Quality Compliance Assessment** Plan, lead and report out on Quality ... **ROLE SUMMARY:** The Senior Issue Lead will be accountable for: + Quality...investigation process including root cause analysis. The Senior Issue Lead will ensure the investigations are conducted… more
- Federal Reserve Bank (Philadelphia, PA)
- …flexible work environment where you can truly find balance. The Software Quality Assurance ( QA ) Engineering Supervisor will lead and deliver quality ... Improvements** + **Relationship Management** + **Engagement Management** The Software Quality Assurance ( QA ) Engineering Supervisor will lead and deliver… 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
- 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
- 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
- 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
- Kelly Services (Juncos, PR)
- …+ Approve planned incidents. + Represent QA on NPI team. + Lead investigations . + Lead site audits. + Own site quality program procedures. + Review ... + Review and approve EMS/BMS alarms. + Approve NC investigations and CAPA records. + Approve change controls. +...with knowledge in Warehouse and Incoming QC operations, in quality oversights, in quality records such as… 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
- ThermoFisher Scientific (Asheville, NC)
- …approval of procedures, training documents, and forms of moderate to high complexity. + Lead and participate in CAPA investigations . + Lead multi-functional ... III, QE and play a vital role in maintaining compliance and quality for our brand-new laboratory equipment. These innovative products impact education, research,… more
- Dairy Farmers of America (Birmingham, AL)
- …ensure preventive maintenance program is robust and adhered to . Collaboratively lead investigations relating to non-conforming events driving to root cause(s) ... **Job Description** GENERAL PURPOSE Manage and lead a quality department and ensure...related issues, complaints, or inquires . Manage plant complaint investigations ensuring a thorough, effective, timely and customer facing… more
- Actalent (Foster City, CA)
- …+ Perform data analysis in support of product quality complaint investigations and quarterly trend analysis. + Assist lead /coordinator with investigations ... Quality Assurance SpecialistMUST HAVE + Experience with deviations, investigations , and CAPA. + 1-2 years of pharmaceutical experience in OSD or Biologics +… more
