Quality Systems Specialist

1 day ago


Petersburg, United States BioSpace, Inc. Full time
About Civica

Civica 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 the consistent availability of affordable medications, particularly for those who need them most.

Job Description

The Quality Systems Specialist - Complaints will join our team at the Petersburg, Virginia site, where we manufacture and supply essential generic sterile injectable medications. This role is critical to ensuring our product portfolio meets pharmacovigilance expectations and prioritizes patient safety.

Key Responsibilities
  • Manage market complaints and adverse events for our product portfolio, ensuring timely submission to applicable health authorities.
  • Process complaints assigned according to relevant SOPs, maintaining accurate quality system records.
  • Support our pharmacovigilance program, collaborating with cross-functional teams to ensure compliance and regulatory requirements are met.
  • Author procedural documents and interpret compliance and regulatory requirements for incorporation into our pharmacovigilance program.
  • Track, trend, and analyze pharmacovigilance metrics for the site, identifying areas for improvement.
Requirements
  • Bachelor's degree with 4+ years of pharmacovigilance/complaints or related quality system experience within a regulated industry.
  • Strong organizational, analytical, and execution skills, with a proven track record of managing multiple projects and priorities.
  • Excellent interpersonal, verbal, and written communication skills, with experience using various software/electronic applications.
  • Self-motivated, flexible, and able to work in a fast-paced, dynamic environment.
What We Offer

Civica is committed to delivering high-quality results, working collaboratively to overcome challenges, and focusing on what matters. We offer a dynamic work environment, opportunities for growth and development, and a chance to make a meaningful impact in the lives of patients.



  • Petersburg, United States Civica Rx Full time

    About Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile...


  • 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...


  • Saint Petersburg, United States Quality Electric & Fire Alarm Inc Full time

    Job OverviewWe are looking for a skilled Fire Safety Systems Specialist to become a vital part of our team at Quality Electric & Fire Alarm Inc. In this role, you will be responsible for the installation, maintenance, testing, and repair of fire alarm systems and related low voltage equipment. A company vehicle may be provided based on your expertise and...


  • Petersburg, United States Civica Rx Full time

    About Civica:Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly...


  • Petersburg, United States Civica Rx Full time

    About Civica:Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly...


  • Petersburg, United States Civica Rx Full time

    Job Title: QA Operations SpecialistCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. As a QA Operations Specialist, you will play a critical role in ensuring the quality and compliance of our manufacturing processes.Key Responsibilities:Review and approve...


  • Petersburg, 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 patients have access to essential medications at affordable prices.Job Summary:The Quality Assurance Specialist will join our team at the Petersburg, Virginia...


  • Petersburg, United States Civica Rx Full time

    About Civica:Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly...


  • St. Petersburg, United States Plasma-Therm Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Plasma-Therm. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services, and for implementing processes to improve our quality control systems.Key ResponsibilitiesQuality Inspection: Conduct thorough inspections...


  • Petersburg, United States 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 affordable, high-quality medications.Job Description:Quality Systems AssociateThe Quality Systems Associate will play a critical role in...


  • St. Petersburg, United States Pro QC International North America Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to conduct SAQ and Sustainability Audits for our clients in St Petersburg, FL. As a Quality Assurance Specialist, you will be responsible for assessing a supplier's quality management system using industry-specific or general standards.Key ResponsibilitiesConduct SAQ and Sustainability...


  • Petersburg, United States 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 the consistent availability of affordable medications, particularly for those who need them most.Job Description:The Quality Systems Associate will play a critical role...


  • Petersburg, United States ABM Industries Full time

    Electrical Systems SpecialistAt ABM Industries, we're seeking a skilled Electrical Systems Specialist to join our team. As a key member of our maintenance team, you'll be responsible for operating and performing repairs on electrical systems, maintaining various equipment, and completing work orders for routine repairs and installation of mechanical,...


  • Petersburg, United States Civica Rx Full time

    About Civica:Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly...


  • Petersburg, United States Civica Rx Full time

    About Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile...


  • Petersburg, United States Path Engineering Full time

    Job SummaryWe are seeking a highly skilled Electrical Systems Specialist to join our team at Path Engineering. As an Electrical Systems Specialist, you will be responsible for analyzing and troubleshooting mechanical, operational, and electrical issues, as well as performing maintenance, wiring, and installation of various electrical systems.Key...


  • Petersburg, 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.Position DescriptionThe Quality Systems Associate - Document Control will join the Civica organization at the Petersburg, Virginia site, bringing their...


  • Petersburg, United States Civica Full time

    About the RoleCivica is seeking a highly skilled Data Integrity Specialist II to join our team. As a key member of our quality assurance team, you will be responsible for maintaining our data governance program, including design, operation support, and monitoring.Key ResponsibilitiesDesign and implement data process flows, assign risk rankings, and identify...


  • Petersburg, United States Civica Rx Full time

    About Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile...


  • Petersburg, United States 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 the consistent availability of affordable medicines for patients in need.Job Description:Quality Systems Associate - Document ControlThe Quality Systems Associate -...