Senior QA Specialist - GMP Medical Device/Regenerative Medicine
Organogenesis Inc.
Organogenesis Inc. is seeking a QA Specialist to support new product production and quality review in a regulated environment. You will inspect, release, and validate batches while coordinating cross-functional QA activities with Production, Facilities, Validation, Calibration, Materials, Quality Control, and Logistics. The role emphasizes documentation reviews, batch release, and collaboration with external entities like contractors, suppliers, and customers to ensure regulatory compliance. #J-18808-Ljbffr Organogenesis Inc.
$71.7k - $83.2k
About Us We are a leading regenerative medicine company in the advanced and acute wound... ...Organogenesis What You Will Achieve: The QA Specialist performs quality activities in... ...combination 5-8 years of GMP experience in a Medical Device/Biotechnology industry. Demonstrated...Medical deviceTemporary workFor contractorsImmediate startFlexible hours- ...Framingham, MA seeks a Principal Associate I/II, Quality Assurance to support GMP compliance and product disposition for BDS, DP, and FDP across internal and external facilities. You will collaborate with QA, QC, Regulatory, and Clinical teams, manage batch release,...Senior
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...Role:Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build... ...worldwide.This role is embedded within MSAT, supporting external GMP manufacturing across chemical and biologic modalities, including...SeniorPermanent employmentFull timeWork at officeWork from homeWorldwide$99.5k - $128.5k
...future. Summary of job description: The Senior Associate, Plant Quality Assurance (PQA)... ...Quality Control, Manufacturing, or a related GMP-regulated function. Working knowledge of... ..., including, but not limited to, medical, dental, and vision insurance, 401k match...SeniorLocal areaFlexible hoursAfternoon shift$125k - $160k
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Position SummaryWe are seeking a Senior Application Engineer to provide technical support... ...OEM customers with servo motors, feedback devices, and motion controllers in industries... ...QualificationsExperience in robotics, laboratory automation, medical devices, aerospace, or defense...SeniorMedical deviceFull timeImmediate startFlexible hours- Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical Solutions Regulatory affairs team. They are responsible for regulatory activities associated with new product development and maintenance of business projects. This includes being...SeniorMedical device
- ...1(k) plan for all employees Comprehensive insurance plans for medical, dental and vision coverage for full‑time employees Supplemental... ...plan for all employees Electronic medical records and mobile devices for all clinicians Incentivized bonus plan Responsibilities...Medical deviceFull timeReliefFlexible hours
$169.58k - $233.18k
...valuing your unique contributions. As a Senior Director, Program Management, you will... ...development programs within a global, regulated medical device environment from program initiation... ..., professionals, and skilled specialists, who believe in each individual’s potential...SeniorMedical deviceTemporary workWork at officeLocal area$87.8k - $150k
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