Current jobs related to Stability Program Manager - US Petersburg VA USA - Civica Rx

  • Stability Program Manager

    4 weeks ago

    US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.We are a team of experienced healthcare and pharmaceutical industry leaders, working together...

  • Stability Analyst

    4 weeks ago

    US-, Petersburg, VA, USA Civica Rx Full time

    Job SummaryCivica Rx is seeking a highly skilled Stability Analyst to join our team at our Petersburg, Virginia site. As a key member of our quality assurance team, you will be responsible for ensuring the stability program at our site complies with applicable regulatory requirements and International Council for Harmonization (ICH) guidelines.Key...

  • Stability Analyst

    2 months ago

    Petersburg, United States Civica Rx Full time

    About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They...

  • Housing Stability Case Manager

    4 weeks ago

    Washington, DC , USA, United States Community of Hope Full time

    About the RoleWe are seeking a dedicated and compassionate Housing Stability Case Manager to join our team at Community of Hope. As a key member of our staff, you will play a vital role in supporting individuals and families in achieving housing stability and improving their overall well-being.Key ResponsibilitiesDevelop and implement case management plans...

  • Housing Stability Case Manager

    4 weeks ago

    Washington, DC , USA, United States Community of Hope Full time

    Housing Stability Case Manager Job DescriptionCommunity of Hope is seeking a dedicated and compassionate Housing Stability Case Manager to join our team. As a key member of our Rapid Rehousing program, you will play a vital role in supporting families in gaining and maintaining housing stability.Key Responsibilities:Develop and implement case management...

  • Housing Stability Case Manager

    4 weeks ago

    Washington, DC , USA, United States Community of Hope Full time

    About the RoleWe are seeking a passionate and dedicated individual to join our team as a Housing Stability Case Manager. In this role, you will play a critical part in supporting families in gaining and maintaining housing stability through developing case management plans that incorporate goals for both adults and children related to core areas: finding...

  • Housing Stability Case Manager

    4 weeks ago

    Washington, DC , USA, United States Community of Hope Full time

    Job Title: Housing Stability Case ManagerCommunity of Hope is seeking a passionate and dedicated individual to join our team as a Housing Stability Case Manager. As a key member of our team, you will play a vital role in providing housing stability and income-focused case management services to families assigned to your caseload.About the Role:This is a...

  • Executive Director of the Center for International Stabilization and Recovery

    4 weeks ago

    Harrisonburg, VA , USA, United States Jobelephant (Tony Ngo) - DE Full time

    Job Title: Executive Director of the Center for International Stabilization and RecoveryAbout the Role:The Center for International Stabilization and Recovery (CISR) at James Madison University is seeking an Executive Director to lead its strategic mission. The successful candidate will provide visionary leadership, ensure financial success, and raise the...

  • Executive Director of the Center for International Stabilization and Recovery

    4 weeks ago

    Harrisonburg, VA , USA, United States Jobelephant (Tony Ngo) - DE Full time

    About the Center for International Stabilization and RecoveryThe Center for International Stabilization and Recovery (CISR) is a leading institution dedicated to understanding and overcoming global conflict. With a strong commitment to community engagement and cross-cultural competence, CISR has been a driving force in the humanitarian mine action and...

  • Housing Stability Case Manager

    4 weeks ago

    Clearwater, FL, USA, United States Directions for Living Full time

    Job SummaryWe are seeking a skilled and compassionate Case Manager to join our team at Directions for Living. As a Housing Stability Case Manager, you will work with families who are experiencing homelessness or housing instability, providing intensive case management services to help them achieve stable housing.Key ResponsibilitiesAssess and link families...

  • Histology Laboratory Specialist

    4 weeks ago

    US-, Northlake, SC, USA Stability Direct Full time

    Job Title: Histology TechnicianStability Direct is seeking a skilled Histology Technician to join our team in Atlanta, Georgia.Job Summary:We are looking for a highly motivated and detail-oriented individual to work in our Histology Lab and Morgue. The successful candidate will be responsible for receiving, preparing, and processing surgical specimens for...

  • Bilingual Lead Case Manager

    3 weeks ago

    Madison, WI , USA, United States National Youth Advocate Program Full time

    Job SummaryWe are seeking a highly skilled and experienced Bilingual Lead Case Manager to join our team at National Youth Advocate Program. The successful candidate will be responsible for coordinating case management and safe and timely release services, training new case managers, and supervising the work of other case managers.Key ResponsibilitiesProvide...

  • Executive Director of the Center for International Stabilization and Recovery

    4 weeks ago

    Harrisonburg, VA , USA, United States Jobelephant (Tony Ngo) - DE Full time

    About the RoleWe are seeking an exceptional Executive Director to lead the Center for International Stabilization and Recovery (CISR) at James Madison University. As a key member of the university's leadership team, you will be responsible for providing visionary leadership, ensuring the center's financial success, and raising its international profile.Key...

  • Program Manager

    4 weeks ago

    Lynchburg, VA , USA, United States L3Harris Full time

    Job Title:Program ManagerJob Summary:L3Harris is seeking a skilled Program Manager to join our Land Mobile Radio implementation team in the Public Safety and Private Communications sector. The successful candidate will be responsible for managing the cross-functional team, ensuring the successful delivery of LMR systems to customers within scope, schedule,...

  • IT Program Manager

    4 weeks ago

    US-, Kansas, OK, USA Elan Partners Full time

    Job Title: IT Program ManagerJob Type: ContractLocation: Kansas City, MOJob Description:We are seeking a highly skilled IT Program Manager to lead large and high-profile projects from initial planning to delivery in a SAFe environment. The ideal candidate will have experience working with AI and managing delivery of product development-based programs and/or...

  • Sterile Product Validation Manager

    3 weeks ago

    US-, Petersburg, VA, USA Civica Rx Full time

    Job Description:The Validation Manager for Sterile Injectables will lead Aseptic Simulation Studies for Sterile Products and Bio-similar products at Civica Rx, Petersburg. This role will be responsible for designing and developing the Aseptic Process Simulation (APS) program for Aseptic and Biosimilar injectables.Key Responsibilities:Design and develop the...

  • Travel Nurse RN

    4 weeks ago

    US-, Petersburg, VA, USA OneStaff Medical Full time

    Unlock Your Career Potential with OneStaff MedicalWe're a nationally-recognized and independently-owned staffing firm dedicated to helping talented nurses like you find their dream assignments. With a strong work ethic forged in the Midwest, we're committed to standing by your side and providing unparalleled support throughout your travel nursing journey.The...

  • Program Manager

    4 weeks ago

    US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Program Manager will support and manage the day-to-day activities for new product launch projects with the objective to successfully commercialize and launch new products for Sun Pharmaceutical Industries, Inc. He/she will develop end-to-end highly detailed cross-functional project plans that capture launch critical activities, KPIs,...

  • Diagnostic Imaging Specialist

    3 weeks ago

    Berkshire, MA , USA, United States Stability Direct Full time

    Stability Direct is seeking a highly skilled Mammography Technologist to join their team in Berkshire, Massachusetts.Job Description & RequirementsSpecialty: Mammography TechnologistDiscipline: Allied Health ProfessionalDuration: OngoingShift: 8 hoursEmployment Type: StaffAs a Mammography Technologist at Stability Direct, you will be responsible for...

  • Senior Manager of Operational Technology

    4 weeks ago

    US-, Petersburg, VA, USA Civica Rx Full time

    About Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to essential medications.Job Description:Senior Manager of Operational TechnologyWe are seeking a highly skilled Senior Manager of Operational...

Stability Program Manager

2 months ago

US Petersburg VA USA Civica Rx Full time
About Civica Rx

Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.

We are a team of experienced healthcare and pharmaceutical industry leaders, working together to make a difference in the lives of patients. Our organization is committed to Do What Is in the Best Interest of Patients, and we strive to deliver high-quality results while overcoming challenges and focusing on what matters.

Job Summary

The Stability Analyst will join our team at the Petersburg, Virginia site, bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as our new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

The role is essential to assure our stability program complies with applicable regulatory requirements and International Council for Harmonization (ICH) guidelines.

Key Responsibilities
  • Work cross-functionally to establish and maintain the stability program at Civica Rx Petersburg.
  • Author stability protocols for new drug products and annual commitment batches, as per current procedures and regulatory requirements.
  • Build plans for ensuring stability commitments are met.
  • Support the shipment of samples to external testing facilities.
  • Act as primary contact with Contract laboratories to coordinate and monitor stability protocols and testing schedules.
  • Responsible for assessing stability requirements related to changes.
  • Participate or lead stability investigations.
  • Track sample receipt, testing, and obtain results and raw data from contract labs.
  • Build and manage stability data in the LIMS system.
  • Support Annual Product Quality Reviews and Annual Reports by providing relevant stability reports as needed.
  • Support overall sample management and Quality Control Operations as needed.
  • Compile and evaluate stability metrics, trend data, and report to Management.
  • Ensure that all aspects of the handling, stability samples at the site comply with Civica Rx and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
Requirements
  • Bachelor's degree in a scientific discipline with a minimum of 8 years Quality/CGMP experience in the pharmaceutical industry.
  • Experience in managing stability studies.
  • Excellent written/oral communication skills with a strong discipline in Microsoft Programs.
  • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
  • Ability to work autonomously within established guidelines, procedures, and practices.
  • Committed to delivering high-quality results, overcoming challenges, and focusing on what matters.
  • Continuously looking for opportunities to learn, build skills, and share learning.
Preferred Qualifications
  • Experience with Laboratory Information Management Systems (LIMS).