Senior QA Specialist

7 days ago

Tarrytown, United States RCM Life Sciences and IT Full time

Contract / 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 expected post-validation. Responsibilities: Ensure IT processes and procedures meet Quality System requirements. Participate and support the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives. Provides support and guidance with quality system records activities such as change controls, corrective and prevention action plans (CAPAs), risk assessments, data integrity initiatives, deviations, internal and external audits, standard operating procedure (SOPs), work instructions/job aids, policies, etc. Provide ongoing support to the Quality Auditing function with respect to IT vendors and audits. Support the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process. Collaborate with other functional areas to collect information and provide guidance through all stages of the quality management system and improvement projects Ensures new systems/processes/procedures are compliant with SOPs, WIs and data and regulatory guidelines for IT and Software validation proces Assist in resolution of inspection management concerns as it relates to software applications process, procedures, and data integrity Qualifications: 7 years of experience in IT, Computer Science, Engineering, or Chemistry in an FDA regulated manufacturing environment. Thorough understanding of IT CSV and QA IT roles and responsibilities in support of GxP compliance is required Experience working in an FDA regulated environment with a strong emphasis on a risk-based approach to validation/qualification Strong knowledge of FDA CFRs, Eudralex, and other biotech/pharma industry regulations (pertaining to IT, laboratory systems, automation, and manufacturing) Strong knowledge of Data Integrity, System Development Life Cycle (SDLC) validation methodology and Software Quality requirements. Understanding of root cause analysis and risk management techniques. Experience with quality management systems including change control, incident management, and deviation management Strong Project Management experience leading efforts requiring coordination between cross functional teams within at least one area of systems validation - e.g., laboratory equipment, facilities, utilities, manufacturing equipment, information systems, etc. Education & Certifications: Bachelor's degree in a relevant field (e.g., Life Science, Computer Science, Engineering, Information Technology) preferred. Equal Opportunity Statement: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. About RCM: RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.

  • Senior QA Specialist

    3 weeks ago

    Tarrytown, United States RCM Life Sciences and IT Full time

    Contract / 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...

  • Senior Living Care Specialist

    3 days ago

    Tarrytown, New York, United States Brightview Senior Living Full time

    We're seeking a compassionate and caring individual to join our team as a Senior Living Care Specialist. In this role, you'll have the opportunity to make a meaningful difference in the lives of our seniors.About UsAt Brightview Senior Living, we're dedicated to delivering top-notch services and groundbreaking care. Our supportive and inclusive environment...

  • Lead Cardiovascular Technologist

    4 days ago

    Tarrytown, New York, United States Northwell Health Full time

    **Job Summary:**We are seeking a highly skilled Lead Cardiovascular Technologist to join our team at Northwell Health. As a senior imaging specialist, you will play a key role in guiding and mentoring cardiovascular technologists in the performance of duties. Your expertise and leadership skills will ensure the delivery of exceptional patient care and...

  • Senior Clinical Data Management Specialist

    1 week ago

    Tarrytown, New York, United States Lifelancer Full time

    Company OverviewLifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharmaceuticals, and IT.Job SummaryWe are seeking an experienced Senior Clinical Data Management Specialist to join our team. This role will oversee data management activities across multiple clinical studies, providing expert guidance and...

  • Senior Manufacturing Process Engineer

    2 months ago

    Tarrytown, United States BrightHire Search Partners Full time

    Senior Manufacturing Process EngineerOur client has created a world-class product that is advancing how medical institutions analyze and diagnose tissue samples. Our client works with one of the top hospitals in the country. They are using automation, and cutting-edge robotic and optical technology to create a revolutionary imaging and analysis device.We are...

  • Research Efficacy Specialist

    1 week ago

    Tarrytown, New York, United States Belcan Full time

    Job Title: Research Efficacy Specialist">About the RoleWe are seeking a skilled Research Efficacy Specialist to join our Clinical Testing and Performance Department in Tarrytown, NY. In this role, you will be responsible for conducting clinical trials using various instrumentation and imaging tools as specified by the study protocol under the supervision of...

  • Fox Rehabilitation | Fitness Specialist | tarrytown, ny

    2 weeks ago

    tarrytown, United States Fox Rehabilitation Full time

    FOX is seeking a top-caliber Fitness SpecialistNew Fitness Specialist opportunity in our Senior Living community!With over 100 residents, there will be ample opportunities to shape and mold the program for optimal growth and career opportunities.The position will start as part time (about 3-5 hours weekly), with potential for more hours as the role...

  • Fox Rehabilitation | Fitness Specialist | tarrytown, ny

    2 weeks ago

    tarrytown, United States Fox Rehabilitation Full time

    FOX is seeking a top-caliber Fitness SpecialistNew Fitness Specialist opportunity in our Senior Living community!With over 100 residents, there will be ample opportunities to shape and mold the program for optimal growth and career opportunities.The position will start as part time (about 3-5 hours weekly), with potential for more hours as the role expands. ...

  • Senior Manager, Global Patient Safety Specialist

    1 week ago

    Tarrytown, New York, United States Lifelancer Full time

    Job OverviewLifelancer is a talent-hiring platform connecting professionals with opportunities in life sciences, pharma, and IT.We are seeking an experienced Senior Manager to join our team. This role will be responsible for Intake and ICSR submissions for the company product portfolio, covering pre and post-marketing activities.Key...

  • Financial Accounting Specialist

    1 week ago

    Tarrytown, New York, United States Creative Financial Staffing Full time

    Senior Accountant NYCreative Financial Staffing has partnered with a local consumer products company to fill a Senior Accountant position. This role is ideal for an experienced and detail-oriented accounting professional looking to contribute to the financial integrity and efficiency of their organization.About the Company:Growing importer and distributor of...

  • Fitness Specialist

    1 week ago

    Tarrytown, NY, United States Fox Rehabilitation Full time

    FOX is seeking a top-caliber Fitness SpecialistNew Fitness Specialist opportunity in our Senior Living community!With over 100 residents, there will be ample opportunities to shape and mold the program for optimal growth and career opportunities.The position will start as part time (about 3-5 hours weekly), with potential for more hours as the role expands....

  • Payroll Manager Specialist

    7 days ago

    Tarrytown, New York, United States Partnership Employment Full time

    Job Title: Assistant Payroll ManagerAbout the RolePartnership Employment is seeking an experienced Assistant Payroll Manager to join our team. As a key member of our payroll department, you will be responsible for managing various payroll-related tasks and ensuring compliance with federal, state, and local laws.Key ResponsibilitiesWork closely with the Human...

  • Global Patient Safety Specialist Leader

    3 days ago

    Tarrytown, New York, United States Lifelancer Full time

    Regeneron's Global Patient Safety Team is looking for a Senior Manager to lead the initial intake of adverse event data and subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Collaborators and internal destinations.This role involves leading a team responsible for Intake and ICSR submissions for the company product...

  • Complex Claims Specialist

    2 days ago

    Village of Tarrytown, NY, United States CNA Insurance Full time

    You have a clear vision of where your career can go. And we have the leadership to help you get there. At CNA, we strive to create a culture in which people know they matter and are part of something important, ensuring the abilities of all employees are used to their fullest potential. CNA is the market leader in providing Lawyers liability coverage and...