Current jobs related to Principal Quality Systems Specialist - Tarrytown - Regeneron Pharmaceuticals, Inc
-
Quality Specialist
3 weeks ago
Tarrytown, United States LS Solutions Full timeJob Title: QAIT Quality Specialist Location: Tarrytown, NY Duration: 6 + Months extensionSummary: The Consultant – QAIT Quality (Consultant) specialist will provide guidance to support IT Quality and Data Integrity programs in the organization. The Consultant will serve as SME by supporting investigations, risk assessments, and IT Operations while...
-
Principal Scientist
3 weeks ago
Tarrytown, United States Joulé Full timeTitle: Principal Scientist (Biospecifics) Location: Tarrytown, NY Schedule: M-F Full Time Type: Contract Responsibilities: Seeking a motivated and skilled Principal Scientist to join a dynamic team developing immunotherapies in the oncology space. You will independently conduct in vitro and in vivo studies and work with a cross-collaborative team to...
-
Principal Scientist
3 weeks ago
Tarrytown, United States Joulé Full timeTitle: Principal Scientist (Biospecifics)Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below. Location: Tarrytown, NY Schedule: M-F Full Time Type: Contract Responsibilities: Seeking a motivated and skilled Principal Scientist to join a dynamic team developing...
-
Tarrytown, New York, United States Regeneron Pharmaceuticals Full timeJob Summary: We are seeking a highly skilled Quality Assurance Specialist to join our team at Regeneron Pharmaceuticals.Key Responsibilities:Perform activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.Work closely with Clinical...
-
Quality Enhancement Specialist
4 weeks ago
Tarrytown, New York, United States IAHD-Institute for Applied Human Dynamics Full timeJob SummaryThe Quality Enhancement Specialist at IAHD-Institute for Applied Human Dynamics is responsible for ensuring that all programs and services meet the highest standards of quality and regulatory compliance. This role involves conducting comprehensive internal audits of documentation and practices to verify adherence to federal, state, and...
-
Principal Scientist
2 weeks ago
Village of Tarrytown, United States System One Full timeTitle: Principal Scientist (Biospecifics) Location: Tarrytown, NY Schedule: M-F Full Time Type: ContractResponsibilities:Seeking a motivated and skilled Principal Scientist to join a dynamic team developing immunotherapies in the oncology space. You will independently conduct in vitro and in vivo studies and work with a cross-collaborative team to assess...
-
Quality Assurance Validation – Medical Device
3 weeks ago
Tarrytown, United States Grove Technical Resources, INC Full timeJob Title: Quality Assurance Validation – Medical DeviceLocation: Onsite, 1 Global View and Tarrytown, NY Duration: 6 months + extensions Type: W2 contractSummary: The Consultant – QAIT Quality (Consultant) specialist will provide guidance to support IT Quality and Data Integrity programs in the organization. The Consultant will serve as SME by...
-
Tarrytown, New York, United States Regeneron Pharmaceuticals, Inc Full timeJob Title: Senior Principal Secure Software Development Life Cycle EngineerWe are seeking a highly skilled Senior Principal Secure Software Development Life Cycle Engineer to join our team at Regeneron Pharmaceuticals, Inc. This individual will be responsible for designing, engineering, deploying, governing, and providing level 3 support for the Regeneron...
-
Tarrytown, United States Regeneron Pharmaceuticals, Inc Full timeWe are looking for a Sr Principal Secure SDLC Software Development Engineer who will be responsible for the design, engineering, deployment, governance and level 3 support of the Regeneron Secure Software Development Life Cycle (SSDLC) framework, solutions, and services, aligning with the Cybersecurity by Design program, in a global environment. As a Sr...
-
Hydraulic Systems Specialist
4 weeks ago
Tarrytown, New York, United States INTECH Full timeAbout The PositionINTECH Process Automation is seeking a skilled Hydraulic Technician to support the maintenance and repair of hydraulic machinery, equipment, and components. The ideal candidate will have experience diagnosing, maintaining, and repairing hydraulic systems, as well as a strong understanding of mechanical systems and...
-
Mechanical Systems Specialist
4 weeks ago
Tarrytown, New York, United States Six Construct Full timeMechanical Engineer RoleAt Six Construct, we are seeking a skilled Mechanical Engineer to join our team. The successful candidate will be responsible for ensuring the optimal performance and reliability of mechanical systems and equipment within our facilities.Key Responsibilities: Conduct regular maintenance and inspections on mechanical systems and...
-
Senior QA Specialist
1 day ago
Tarrytown, United States RCM Life Sciences and IT Full timeContract / Right to Hire: Title: Senior QA Specialist Compensation: Up to $70 Per Hour, Commensurates with experience. Location: Tarrytown, NY Length of Contract: 1 Year Position Description: The Senior QA Specialist will serve as SME by supporting investigations, risk assessments, and IT Operations while verifying that GxP computerized systems operate as...
-
Quality Assurance Specialist
1 month ago
Tarrytown, New York, United States Emerge Talent Cloud Full timeJob OverviewPrestige Consumer Healthcare is a leading company in the over-the-counter healthcare and women's health categories, focusing on product innovation and quality to improve the lives of customers and their families. We are the largest independent provider of over-the-counter products in North America, constantly improving and creating products that...
-
Principal Electronic Warfare Systems Engineer
1 month ago
Tarrytown, New York, United States Asterix Communications Full timepstrongAboutAsterixCommunications/strong/ppAsterixCommunicationsisaregionalandinternationalleaderthatoffersnext-generationelectronicwarfaresystemsandroboticsexpertisetomeetthechallengesofarapidlychangingworld./ppWehavedevelopedin-houseexpertiseacrosstheentirevaluechainforelectronicwarfaresystems,includingdesign,development,testing,manufacturing,andassembly.O...
-
Senior Quality Assurance Specialist
1 month ago
Tarrytown, New York, United States Katalyst HealthCares & Life Sciences Full timeJob Summary: We are seeking a highly skilled Senior Quality Engineer to join our team at Katalyst HealthCares & Life Sciences. The successful candidate will be responsible for reviewing technical files from a quality perspective, ensuring compliance with the EU MDR standard.Key Responsibilities:* Review technical files for EU MDR compliance* Validate test...
-
Medical Billing Specialist
1 month ago
Tarrytown, New York, United States ENT and Allergy Associates Full timeJob SummaryENT and Allergy Associates is seeking a highly motivated and detail-oriented Medical Billing Specialist to join our team. As a key member of our revenue cycle team, you will be responsible for reviewing, correcting, and billing encounters for submission to the clearinghouse, ensuring compliance with timely filing deadlines.Key...
-
Technical Application Specialist
4 weeks ago
Tarrytown, New York, United States Siemens Medical Solutions USA, Inc Full timeRole SummaryWe are seeking a highly skilled Technical Application Specialist to join our team at Siemens Healthineers. As a Technical Application Specialist, you will be responsible for providing implementation services, training, and troubleshooting on our instrumentation and data management applications.Key ResponsibilitiesProvide excellent customer...
-
GxP compliance and Data integrity Specialist
3 weeks ago
Tarrytown, United States Master Compliance Full timeJob Title: Quality Assurance Validation – Medical DeviceLocation: Tarrytown, NY (on site)Duration: 6 months + extensions Type: W2 contractSummary:The Consultant – QAIT Quality (Consultant) specialist will provide guidance to support IT Quality and Data Integrity programs in the organization.The Consultant will serve as SME by supporting investigations,...
-
Technical Support Specialist
4 weeks ago
Tarrytown, New York, United States Siemens Medical Solutions USA, Inc Full timeJob DescriptionJob Title: Technical SupporterJob Summary: We are seeking a highly skilled Technical Supporter to join our team at Siemens Medical Solutions USA, Inc. The successful candidate will provide implementation services, train-the-trainer education, and troubleshooting on all Siemens Healthineers instrumentation and Data Management applications.Key...
-
Tarrytown, New York, United States System One Holdings, LLC Full timeJob Title: Biostatistician - Immunology & Inflammation SpecialistJob Summary: We are seeking a skilled Biostatistician to join our team at System One Holdings, LLC. As a Biostatistician - Immunology & Inflammation Specialist, you will be responsible for implementing and executing methodological and statistical aspects of clinical studies under the...
Principal Quality Systems Specialist
6 months ago
Summary: The Quality System Specialist participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Engineering, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations. The Quality Systems Specialist provides oversight of the Quality Management System (QMS) implementation and use. This position may also support global elements of the QMS and lead or participate in continual improvement initiatives.
Essential Duties and Responsibilities : include, but are not limited to, the following:
Responsible for ensuring compliance with all aspects of quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
Maintains regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
Collaborates with cross functional teams to resolve issues, complete investigations and maintain compliance.
Responsible for QA review and approval of the following types of documents:
- Failure investigations
- Corrective and preventative actions (CAPA)
- Standard operating procedures (SOP’s)
- GxP documents
- Change control documents
Reviews various system records for assignment, compliance, and closure.
Provides administrative support of electronic systems
Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
Provision of monitoring and trending metrics associated with site quality systems.
Actively participate in continuous improvement ideas, initiation, and implementation.
Participation in internal, regulatory and customer audits.
May train personnel on quality system processes.
May supervise team members.
Perform additional duties as requested.
Education and Experience:
Principal Quality Systems Specialist: Requires BS/BA in scientific discipline or related field and 8 years of industry/relevant experience or equivalent combination of education and experience.
Senior Quality Systems Specialist: Requires BS/BA in scientific discipline or related field and 5 years of industry/relevant experience or equivalent combination of education and experience.
Knowledge, Skills, and Abilities:
Ability to develop relationships and coach business users on QMS system requirements.
Excellent written, oral and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences.
Excellent time management, communication, and organizational skills along with a proven ability to multi-task required.
Knowledge of quality and cGMP principles and systems and relevant regulatory guidelines.
Exhibits a drive for results, dealing with ambiguity, learning on the job and individual courage with a strong attention to detail.
Project management skills with the ability to manage many diverse tasks simultaneously.
Effectively organizes and manages work responsibilities under general guidance.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
#JOBSIEPR #IRELIM #REGNIEQA #LI-Onsite
