Stability Program Manager

1 week ago

Virginia State University VA United States 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 delivering high-quality results, 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.

Responsibilities
  • Work across functions to support the development and maintenance of 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 the appropriate 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.
  • Practice and promote a safety and quality mindset and a quality excellence approach to all activities.
  • Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
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 is required.
  • 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.

  • 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 led by an experienced team of healthcare and pharmaceutical industry leaders, with a...

  • Stability Program Manager

    2 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 Program Manager

    2 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 Program Manager

    1 week 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...

  • QC Stability Manager

    3 weeks ago

    Redwood City, CA, United States Adverum Biotechnologies Full time

    Redwood City, CA Quality Control Full Time We are seeking a highly motivated and experienced QC Stability Manager to join our Quality Control team at Adverum. The QC Stability Manager will be responsible for overseeing the stability program to ensure the safety, efficacy, and quality of our products throughout their shelf life. This role involves managing...

  • Travel Interventional Radiology Technologist

    1 month ago

    Powell, TN, United States Stability Healthcare Full time

    Job SummaryStability Healthcare is seeking a skilled Interventional Radiology Technologist to join our team for a 13-week contract in Powell, Tennessee.Key ResponsibilitiesProvide high-quality patient care and imaging services in an interventional radiology setting.Collaborate with radiologists and other healthcare professionals to ensure accurate diagnoses...

  • Housing Stability Specialist

    3 weeks ago

    , MI, United States Mel Trotter Ministries Full time

    Job DescriptionWe are seeking a dedicated and compassionate Housing Stabilization Case Manager to join our team at Mel Trotter Ministries. As a key member of our Housing Stabilization Program, you will work closely with clients who have experienced chronic homelessness to help them maintain housing, achieve health and wellness goals, and secure financial...

  • Case Manager

    4 weeks ago

    Fairfax, Virginia, United States Shelter House Full time

    {"title": "Case Manager", "description": "About the RoleThe Case Manager plays a critical role in supporting families at risk of homelessness or recently housed. This position requires a self-starter who can provide ongoing, community-based services, identify and address immediate needs, develop money management skills, and support gainful employment search...

  • Chemistry Senior Stability Coordinator

    3 weeks ago

    Windsor, CT, United States SCA Pharmaceuticals, LLC Full time

    Description:SCA Pharmaceuticals is a dynamic rapidly growing company consisting of passionate individuals who believe in our mission of providing high quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility providing customized medications for hospitals and healthcare facilities across the...

  • Pharmacist Manager

    3 weeks ago

    Clear Lake, CA, United States Stability Direct Full time

    Job Summary:Stability Direct is seeking a highly skilled and experienced Pharmacist to manage the operation of the pharmacy department. The ideal candidate will have a strong background in pharmacy management, leadership, and regulatory compliance.The successful candidate will be responsible for overseeing the daily operations of the pharmacy, including...

  • Program Manager

    2 weeks ago

    , CA, United States Developmental Pathways Inc. Full time

    Job SummaryDevelopmental Pathways Inc. is seeking a highly skilled and dedicated Program Manager to join our team. As a key member of our clinical staff, the Program Manager will be responsible for managing client caseloads, providing supervision, and collaborating with our Clinical Supervisor to deliver high-quality ABA clinical interventions.Key...

  • Traveling Registered Nurse

    1 month ago

    State College, Pennsylvania, United States Stability Healthcare Full time

    Job Title: Traveling Registered Nurse - Cardiac Cath LabJob Summary:Stability Healthcare is seeking a skilled Travel Nurse RN to work in a Cardiac Cath Lab setting. As a Travel Nurse RN, you will have the opportunity to work in a dynamic and challenging environment, providing high-quality patient care and contributing to the success of our healthcare...

  • Procurement Manager

    1 month ago

    VIRGINIA STATE UNIVERSITY, VA , USA, United States Virginia Department of Transportation Full time

    Job SummaryThe Virginia Department of Transportation is seeking a highly skilled Procurement Manager to join our team in Culpeper, Virginia. As a key member of our Administrative Services Division, you will provide technical consulting assistance, training, guidance, and recommendations to district procurement personnel for procurement operations.Key...

  • Program Management Manager

    1 week ago

    McLean, VA, United States Freddie Mac Full time

    Job Title: Program Management ManagerAt Freddie Mac, we are seeking a highly skilled Program Management Manager to join our Single Family Portfolio and Servicing (SFPS) team. As a Program Management Manager, you will be responsible for managing key integrated SFPS programs that have technical impacts across the SFPS blocks.Key Responsibilities:Develop...

  • Program Manager

    3 weeks ago

    Alexandria, Virginia, United States ITC Federal, Inc. Full time

    Job Title: Program Manager - Systems SupportITC Federal, Inc. is seeking a highly skilled Program Manager to oversee the daily operations and maintenance of IT systems for the US government. This is a challenging role that requires strong leadership, communication, and problem-solving skills.Key Responsibilities:Manage a team of IT support personnel to...

  • Travel Nurse RN Med Surg

    4 weeks ago

    VIRGINIA STATE UNIVERSITY, VA , USA, United States RNnetwork Full time

    Job Title: Travel Nurse RN Med Surg / TelemetryRNnetwork is seeking a skilled travel nurse RN Med Surg / Telemetry to join our team in Petersburg, Virginia.About the JobSpecialty: Med Surg / TelemetryDiscipline: RNShift: 12 hours, daysEmployment Type: TravelAs a travel nurse in Med Surg / Telemetry, you will play a vital role in providing high-quality...

  • Medical Device Engineer

    2 weeks ago

    VIRGINIA STATE UNIVERSITY, VA , USA, United States BioSpace, Inc. Full time

    About CivicaCivica 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. Our mission is to do what is in the best interest of patients.Job DescriptionThe engineer will be responsible for designing and transferring injection pen...

  • Program Manager

    2 weeks ago

    University Park, United States Penn State University Talent Acquisition Full time

    Job SummaryWe are seeking a highly motivated and organized Program Manager to join our team at the National Synthesis Center for Emergence in the Molecular and Cellular Sciences within the Huck Institutes of the Life Sciences at Penn State.Key ResponsibilitiesCoordinate the diverse range of research efforts at the center, ensuring seamless execution of...

  • Program Manager

    4 weeks ago

    Fort Belvoir, VA, United States Department of the Army Full time

    Job SummaryWe are seeking a highly skilled and experienced Program Manager to join our team at the Department of the Army. As a key member of our organization, you will be responsible for leading and managing complex programs, ensuring successful execution, and driving strategic growth.Key ResponsibilitiesDevelop and implement program strategies that align...

  • Program Manager

    2 weeks ago

    Fort Belvoir, VA, United States Department of the Army Full time

    Job SummaryWe are seeking a highly skilled and experienced Program Manager to join our team at the Department of the Army. As a Program Manager, you will be responsible for maintaining budget functions for contract portfolios and contractual acquisition programs and activities.Key ResponsibilitiesMaintain budget functions for contract portfolios and...