- Regeneron Pharmaceuticals (Troy, NY)
- …ensuring DG principles are embedded in the site culture. As a Senior GMP Data Governance & Engagement Specialist , a typical day might include the following: ... of these within IOPS + Fostering a culture of quality & DG within the organisation and promoting the...seeking feedback and supporting initiatives designed to enhance data quality and governance + Leading/supporting initiatives to embed DG… more
- Mayo Clinic (Jacksonville, FL)
- …will be part of a team of four, consisting of the site QA manager, one QA specialist and two senior QA specialists. + Is responsible for oversight of quality ... independently schedule workday activities with minimal direction. ASQ certification in quality and/or GMP principles (eg, quality process analyst, quality… more
- Astellas Pharma (Westborough, MA)
- ** Senior Validation Specialist , Quality Assurance** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? ... research programs. AIRM is headquartered in Massachusetts. Astellas is announcing a ** Senior Validation Specialist , Quality Assurance** opportunity at their… more
- Integra LifeSciences (Boston, MA)
- …treatment pathways to advance patient outcomes and set new standards of care. The Senior Quality Compliance Specialist -Training will create and conduct ... skills and competencies of employees in a medical device-regulated environment. The Senior Training Specialist will assess training needs, develop curriculum,… more
- Merck (West Point, PA)
- …products through pipeline acceleration and uninterrupted supply of commercial product. The ** Senior Specialist ** , BCR Sciences is an individual contributor role ... enhanced operational and digital capabilities. **Primary Activities** As a BCR Sciences ** Senior Specialist ** for Large Molecule Biologic Critical Reagents, this… more
- Merck (West Point, PA)
- … systems, regulatory intelligence, and the Quality Management System (QMS). The Senior Specialist role reports into the Global Quality Systems ... quality assurance, quality systems, auditing, quality management systems or other GMP compliance...systems, auditing, quality management systems or other GMP compliance activities. + Strong computer skills, experience with… more
- Boehringer Ingelheim (Fremont, CA)
- …supervision and according to standard operating and QC procedures. Technical and Quality lead for non-routine, new method transfer / validations / qualifications, ... verifications and technical assessments. Responsible for quality and compliance activities including new test methods, specs,...years of work experience in analytical testing in a GMP regulated industry or equivalent; Or + Masters degree… more
- Fujifilm (Thousand Oaks, CA)
- …our workplace, our company, our community and the world at large. The Senior Quality Control Instrumentation Specailist will author, review, approve laboratory ... as they pertain to lab instrumentation. **External US** **Sr. Specialist , Quality Control - QC Instrumentation** **QC...from procurement through validation for both direct and indirect GMP impact systems. The candidate must have strong … more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …Familiarity with plasma fractionation and purification, aseptic processing, filling, sterilization, GMP regulations, and Quality Operations are desirable. * Must ... managers, supervisors, and technicians/operators from the following departments: Manufacturing, Quality , Instrumentation, GMP , and Engineering. + Develops… more
- Verista (Boston, MA)
- …experiences to enhance our collective expertise Responsibilities: + As part of the GMP Operational Quality group primarily responsible with providing quality ... release + Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product … more
- Bristol Myers Squibb (Devens, MA)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Specialist of Supplier Quality is responsible for the ... Material Management programs at the Devens Biologics site. This includes Quality management of vendor qualification, material qualification, change management and… more
- Randstad US (Newbury Park, CA)
- quality assurance senior specialist ....and/or experience. + Typically 2 plus years of related quality assurance or manufacturing experience in a GMP ... skills with the ability to manage multiple projects or assignments. skills: Quality Assurance, GMP (Good Manufacturing Practice) Equal Opportunity Employer:… more
- University of Southern California (Los Angeles, CA)
- cGMP Senior Quality Control (QC) SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ Senior ... at the USC/CHLA cGMP Facility will lead advanced quality control activities to ensure the quality ...projects, and collaborating closely with other teams. The QC Senior Specialist will also conduct in-depth analytical… more
- Catalent Pharma Solutions (Harmans, MD)
- …and vaccines. The Sr. Specialist , QA-OTF is responsible for providing Quality Assurance support for GMP Manufacturing of master/working cell banks, ... **Sr. Specialist , QA OTF - Night Shift** **Position Summary**...to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP… more
- Integra LifeSciences (Plainsboro, NJ)
- …challenging what's possible and making headway to help improve outcomes. The ** Senior Training Specialist , Operations** will create and conduct training programs ... competencies of operations employees in a medical device regulated environment. The Senior Training Specialist will assess training needs, develop curriculum,… more
- Actalent (Santa Clara, CA)
- …knowledge of industry practices, techniques, and standards. You will assist the Principle Quality Specialist with the following: o Ensure Quality Management ... with FDA, European MDD/MDR & ISO regulations, the Sr. Quality Systems Specialist will perform work under...Medical Device, quality systems management, Data entry, Quality assurance, Regulatory compliance, Gmp , NCR, Compliance… more
- Bristol Myers Squibb (Summit, NJ)
- …no better place than here at BMS with our Cell Therapy team. The Senior Specialist , Data Integrity role is responsible for assisting with the implementation ... and management of Bristol Myers Squibb's GMP Data Governance and Data Integrity program at the...**Knowledge & Skills:** + Must have familiarity with GMPs, Quality , and Data Integrity principles. + Must be familiar… more
- Bristol Myers Squibb (Devens, MA)
- …personal lives. Read more: careers.bms.com/working-with-us **Position Summary** Provide Quality assistance and oversight to operations, for in-process intermediates ... and manufactured products, and other GMP processes as required. Performs review and approval of...and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- ** Senior Cleaning Validation Specialist ** **Position Summary** Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical ... to solve your most difficult development and manufacturing challenges The ** Senior Cleaning Validation Specialist ** position involves creating cleaning cycle… more
- Catalent Pharma Solutions (Harmans, MD)
- …**Sr. Specialist , QA - Batch Disposition** is responsible for providing Quality Assurance support for GMP documentation of master/working cell banks, bulk ... **Sr. Specialist , QA - Batch Disposition** **Summary:** _Our FDA-licensed,...drug product. Responsibilities include but are not limited to GMP documentation review and supporting other QA functions as… more
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