Sr. Specialist GXP QA

4 weeks ago

Cincinnati, United States cchmc Full time

Description:

Expected Starting Salary Range:

34.50 - 43.54 Promotes the highest standards of integrity and compliance in assigned areas of production and resolves that such activities will be conducted in accordance with regulatory standards

Scope: Individual typically working under the direction of management personnel. REPRESENTATIVE RESPONSIBILITIES ·Regulatory Knowledge & Oversight Independently interpret and analyze the concepts and principles of specific elements of federal and state law and institutional policies/procedures/guidance to ensure that all aspects of manufactured products, regulatory submissions (e.g. Drug Master File) and operational procedures are compliant with regulatory directives and assess the impact of specific regulatory decision on operations. Lead the creation and management of policies and procedures within assigned area.

·Quality Assurance Implements defined document control activities. Performs product release activities with minimal to no oversight. Write (as applicable), review and approve official documents, such as but not limited to executed batch records, validation protocols, deviations, Standard Operating Procedures, deviations, etc. related to the quality management system. Conducts internal and external audits, including vendor qualification audits, develops reports and evaluates corrective actions. Design and lead risk assessments related to manufacturing and testing activities, and document outcomes. Consistently interacts with manufacturing/operations personnel as needed, including interactions with external stakeholders. Identifies and leads the quality improvement activities and may be accountable for achieving defined outcomes.

·Teamwork, Collaboration & Leadership/Management Work collaboratively with diverse teams and interface effectively with primarily internal and occasionally external stakeholders across the organization. Build consensus among stakeholders, based on priorities established by more senior leadership, gaining commitment to achieve defined institutional priorities, while ensuring that the organization is adhering to required regulatory standards. Use basic project management and organizational skills to lead divisional/departmental initiatives. May lead the development and execution of specific aspects of the quality management system in support of the institution's research strategic plan. Contribute to recommendations for solutions that maximize organizational performance. Represent CCHMC at the regional and national level disseminating best practices.

·Training & Development Train personnel on Standard Operating Procedures and FDA regulations. Ensure that provided training meets required standards. Act as a mentor to more junior staff. Serve as the contact for resolution of complex issues, provide education, guidance and work direction. May provide input and feedback to managers on hiring decisions, professional development and performance management. Qualifications: EDUCATION/EXPERIENCE Required:

·Bachelor's degree in a related field

·5-7 years of work experience in a related job discipline OR Master's degree and 3 years of work experience in a related job discipline.

·Applicable professional certification required for promotion from Spec-Quality Assurance

·Applicable professional certification required within 24 months for outside hire Preferred: Unique Skills:

Cincinnati Children's is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families (EEO/AA). #J-18808-Ljbffr

  • TECH-II/SPECIALIST-GXP - Cell Manipulations Lab (CML) - Translational Core Lab

    3 weeks ago

    Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

    Expected Starting Salary Range: 20.71 - 25.24 (Technician-II GxP) 26.42 - 32.71 (Specialist-GxP) SUBFUNCTION DEFINITION: Manufactures and tests cell in gene therapy products for internal and external phase I/II clinical trials. Development; technology transfer; scale up; manufacturing/processing/ and or testing; Qualifications and validations. Analyze data...

  • Sr. Reimbursement Specialist

    3 weeks ago

    Cincinnati, United States UC Health Full time

    UC Health is hiring a Full Time Sr. Reimbursement Specialist. This position will provide support to the Governmental Reimbursement function for UC Health, including support to the Director of System Governmental Reimbursement, as well as system and facility finance leaders, including Chief Financial Officers. The Sr Reimbursement Specialist will report...

  • Sr. Reimbursement Specialist

    3 weeks ago

    Cincinnati, United States UC Health Full time

    UC Health is hiring a Full Time Sr. Reimbursement Specialist. This position will provide support to the Governmental Reimbursement function for UC Health, including support to the Director of System Governmental Reimbursement, as well as system and facility finance leaders, including Chief Financial Officers. The Sr Reimbursement Specialist will report...

  • Sr. Human Resources Specialist

    1 week ago

    Cincinnati, United States Emery Oleochemicals LLC Full time

    Job DescriptionJob DescriptionSr. Human Resources Specialist - Cincinnati Plant

  • Sr. Collections Specialist

    1 week ago

    Cincinnati, United States Tech Providers Full time

    Sr. Collections Specialist Location: Norwood, OH 45212 Duration: 12+ months with the possibility of extension Required: Minimum 2 years of corporate collections experience including interaction with a large customer base. Skills: Minimum 1-year experience in a finance, customer service, or collection background Computer skills - Proficient in Microsoft...

  • Specialist- Sr Clinical Svcs

    2 days ago

    Cincinnati, United States UC Health Full time

    At UC Health, we're proud to have the best and brightest teams and clinicians collaborating toward our common purpose: to advance healing and reduce suffering. As the region's adult academic health system, we strive for innovation and provide world-class care for not only our community, but patients from all over the world. Join our team and you'll be able...

  • Sr Clinical Services Specialist, Ophthalmology

    2 weeks ago

    Cincinnati, United States UC Health Full time

    At UC Health, we're proud to have the best and brightest teams and clinicians collaborating toward our common purpose: to advance healing and reduce suffering. As the region's adult academic health system, we strive for innovation and provide world-class care for not only our community, but patients from all over the world. Join our team and you'll be able...

  • Sr. Director of Indirect and IT Procurement

    4 days ago

    Cincinnati, United States First Student Full time

    First Student, Inc Sr. Director of Indirect and IT Procurement Cincinnati , Ohio Apply Now First for a reasonFirst Student is the largest school transportation provider in North America with more than a century of experience providing safe and reliable transportation. We work with 1,250 school districts in 39 states and 8 Canadian provinces carrying...

  • Sr. Systems Specialist

    3 weeks ago

    Cincinnati, United States Ameresco Full time

    Job DescriptionJob DescriptionPosition Overview: We are seeking an experienced and highly skilled Controls Senior System Specialist to join our team. As a Controls Senior System Specialist, you will play a critical role in the design, implementation, programming, optimization, and management of advanced DDC control systems in commercial buildings. Your...

  • Clinical Specialist

    1 week ago

    Cincinnati, United States GENTHERM MEDICAL, LLC Full time

    At Gentherm, we say, "It's about the person." We're with you on a cold winter day when you turn on your heated seat and steering wheel or helping manage patient body temperature in the operating room, recovering room or intensive care units. We take a human approach with everything we do. As the global market leader of innovative thermal management and...

  • Sr. Design Engineer

    4 weeks ago

    Cincinnati, United States Affinity Executive Search Full time

    Job description: Position Title: Senior Design Engineer Responsibilities: Lead projects of diverse complexity levels from inception to completion Interpret specifications to create comprehensive "General Notes" and "Loads & Reactions" drawings Ensure adherence to relevant standards and regulations such as ASME, API, and safety protocols Review and approve...

  • Quality Assurance Specialist- 3rd shift/11 pm

    5 days ago

    Cincinnati, United States Klosterman Baking Company Full time

    Job DescriptionJob DescriptionAbout Klosterman Baking Company:As a longstanding pillar of quality and taste since our inception in 1892, Klosterman has continuously delivered fresh, delicious bread and baked goods to communities across the Midwest. Our commitment to excellence, combined with a passion for crafting products that delight our customers, has...

  • Senior Clinical Specialist, Endovascular

    4 days ago

    Cincinnati, United States Abbott Laboratories Full time

    Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent...

  • Sr. Compliance Specialist

    2 weeks ago

    Cincinnati, United States Cincinnati Children's Hospital Medical Center Full time

    Expected Starting Salary Range: 34.50 - 43.54 REPRESENTATIVE RESPONSIBILITIES * Institutional Support Serve as a subject matter expert in assigned program area. May be called upon to provide key input, based on knowledge, experience and expertise, on institutional initiatives and programs at the direction of leadership, in order to ensure compliance with...

  • Clinical Quality Specialist

    3 weeks ago

    Cincinnati, United States TriHealth, Inc. Full time

    Job Overview: This position works collaboratively with the Medical Staff Department / Section Chairs, Service Line System Chiefs, and Nursing leadership in the development and support of quality initiatives to improve patient outcomes. Facilitates peer review of clinical performance within QA Committees and initiates further activity to support Medical...

  • Database Administrator Specialist

    1 week ago

    Cincinnati, United States JobRialto Full time

    Description: Expert/lead role requiring extensive skill and proficiency in PL/SQL Development on Oracle platform. Demonstrated competency of the Senior Database Administrator role is required. Works independently with only administrative supervision on highly complex projects with extensive latitude for independent judgment. Expected to be the primary mentor...

  • Database Administrator Specialist

    1 week ago

    Cincinnati, United States Compunnel Full time

    Description: Expert/lead role requiring extensive skill and proficiency in PL/SQL Development on Oracle platform. Demonstrated competency of the Senior Database Administrator role is required. Works independently with only administrative supervision on highly complex projects with extensive latitude for independent judgment. Expected to be the primary mentor...

  • Portfolio Specialist

    1 week ago

    Cincinnati, United States Ascendum Solutions Full time

    Job DescriptionResponsible for managing one of more functional areas of Portfolio Operations within a product led organization that include the following but not limited to capital allocation, capital budget governance, operating budget governance, capacity management, vendor performance governance and contracts management. Demonstrate the company’s core...

  • Portfolio Specialist

    1 month ago

    Cincinnati, United States Ascendum Solutions Full time

    Job DescriptionResponsible for managing one of more functional areas of Portfolio Operations within a product led organization that include the following but not limited to capital allocation, capital budget governance, operating budget governance, capacity management, vendor performance governance and contracts management. Demonstrate the company’s core...

  • Portfolio Specialist

    1 month ago

    Cincinnati, United States Ascendum Solutions Full time

    Job DescriptionResponsible for managing one of more functional areas of Portfolio Operations within a product led organization that include the following but not limited to capital allocation, capital budget governance, operating budget governance, capacity management, vendor performance governance and contracts management. Demonstrate the company’s core...