- Legend Biotech USA, Inc. (Raritan, NJ)
- …support and manage change controls, and maintain permanent inspection readiness and actively support regulatory inspections. Lead facility operating review ... and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Good Practices Guides, and RBA/CSA methodologies to ensure compliance and inspection readiness .Stay current with emerging technologies and industry trends; ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …NN Standard Operating Procedures (SOPs) Advanced knowledge and participation on internal audit/ inspection readiness (ie FDA PADE inspection ) Excellent ... provides support to audits and Health Authority inspections, including readiness activities, to ensure internal/external compliance with requirements/regulations Support,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …first mindset, a Right First Time culture of quality, permanent inspection readiness compliance mindset and passionately drives continuous improvementProvides ... experience working and leading in a matrix environmentAbility to lead with influencecGMP manufacturingMetrology, calibrations, instrumentation, automation PLCs, VFDs… more
- Eisai, Inc (Nutley, NJ)
- …general enrollment figures to COL or leadership team as requestedContribute to inspection readiness , including, but not limited to, creating and updating ... close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical study timelines. Gathers… more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Data Integrity Inspection Readiness Lead uses advanced subject matter expertise ... audit outcomes. *Develops and executes data integrity campaigns, gap assessments, inspection readiness plans, audit observations and responses, and ensures… more
- Parkview Health (Fort Wayne, IN)
- …maintenance. The lead is responsible for keeping the laboratory in continuous readiness for inspection . The Lead is responsible for the consequences ... Summary The Lead Support Tech is responsible for assuring that...the needs of the laboratory's customers are met. The Lead coordinates the daily workflow and oversees the routine… more
- Jabil (West Chester, PA)
- …Be the Champion and subject matter expert for Regulatory Compliance programs. + External inspection readiness and associated activities. Lead and manage site ... assigned sites. You will also drive internal audits and lead the preparation/ readiness activities for customer audits,...audit readiness activities to ensure inspection readiness at all times. + Prepare… more
- GRAIL (Durham, NC)
- …collaborate cross-functionally to proactively manage both GCP and CDx regulatory risks, lead inspection readiness , and continuously improve quality standards ... and CDx programs. + Lead and continuously refine the organization's inspection readiness framework for clinical studies and companion diagnostic development,… more
- Parkview Health (Fort Wayne, IN)
- …+ Visual acuity and color discrimination required Key Performance Areas: + Growth : Lead in inspection readiness , test development, and continuous education ... Parkview Health is seeking a highly skilled and dedicated Lead Scientist-Technologist to join our dynamic laboratory team. This...as a key operator for analyzers + Ensure continuous inspection readiness (CAP, ISDH, JCAHO, etc.) +… more
- Lilly (Durham, NC)
- …the ground up. **Responsibilities:** During the project phase, the Line Lead (Technician) - Inspection will support commissioning/qualification activities ... automated vision systems into service as well as supporting site operational readiness activities. This position may require domestic travel with the opportunity for… more
- Lilly (Durham, NC)
- …is a requirement for this position. During the project phase, the Lead Technician - Visual Inspection will support commissioning/qualificationactivities required ... systems into service as well as supporting site operational readiness activities. This role is expected to become a...to become a subject matter expert for the visual inspection equipment/process and will be directly involved with training… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …will ensure a state of continuous GMP compliance in Regeneron and to build inspection readiness capability across the organization. This role will help to build ... advice and direction to other departments on quality and regulatory issues. + Inspection Readiness + Benchmark leading practices and recommend improvements to… more
- Aerotek (San Antonio, TX)
- … readiness for delivery. **Responsibilities** + Perform verification and inspection of flight component installations and operational functional testing of ... **Job Title: Flight Readiness Technician Inspector (Level C)** **Job Description** We...San Antonio, TX. This non-managerial role involves performing verification, inspection , and testing of aircraft systems to ensure their… more
- Novo Nordisk (Bloomington, IN)
- …7:30am Relationships Reports to Manufacturing Supervisor. Essential Functions + Applies to Inspection and Packaging + Entry-level position with little or no prior ... be able to effectively palletize product and material per written specifications + Inspection + Perform inspection techniques for manual visual inspection … more
- Novo Nordisk (Bloomington, IN)
- …Relationships Reports to Manufacturing Supervisor. Essential Functions + Applies to Inspection and Packaging + Has developed proficiency typically developed through ... the shift to ensure effective and accurate communication of production activities + Inspection + Perform inspection techniques for manual visual inspection … more
- The Boeing Company (North Charleston, SC)
- …**Boeing Commercial Airplanes (BCA)** is currently seeking **Associate or Experienced Flight Readiness Technician (Level B or C)** to support the 787 Program Boeing ... as well as, systems operational functional validation testing. Flight Readiness Technicians perform rework, modification, maintenance, preflight and post-flight… more
- Takeda Pharmaceuticals (Boston, MA)
- …with all applicable internal policies and procedures, regulations, support inspection readiness of all regulated activities. + Lead or participate in special ... quality and alignment to Takeda's requirements, values and policies. + Lead ballparking, contracting and commercial management of complex clinical studies,… more
- Parexel (Glendale, CA)
- …Units. This role ensures first-time quality, robust risk and issue management and inspection readiness by collaborating with operational teams and clients. Key ... office & remote based)** The Project Quality & Risk Lead II is responsible for leading quality and risk...Facilitate root cause analysis (RCA) and corrective/preventive actions (CAPA). ** Inspection Readiness ** + Conduct Inspection … more
- RTX Corporation (East Hartford, CT)
- …worldwide leader in jet engines, is looking for a dedicated individual to lead Deployments of Model Based Manufacturing and Inspection technologies, policies and ... deployment standard work resulting into a playbook for operations to execute MB-DMI readiness + Lead and contribute to deployment level passports for business… more
