Quality Systems Specialist

3 weeks ago

VIRGINIA STATE UNIVERSITY VA USA, 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. Established in 2018 by health systems and philanthropies, Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter.

Job Description

The Quality Systems Specialist - Complaints will join the Civica organization 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 Civica's new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

Key Responsibilities
  • Ensure the consistent application of Civica and regulatory expectations to the management of pharmacovigilance workstreams.
  • Manage related quality system records, including documentation and review of related investigation reports.
  • Perform day-to-day activities of processing market complaints assigned as per the relevant SOPs.
  • Support Civica pharmacovigilance program related to the Petersburg site's products.
  • Authors procedural documents related to area of responsibility.
  • Interprets compliance and regulatory requirements for incorporation into the site's pharmacovigilance program's systems, procedures, and documentation.
  • Track, trend, and analyze pharmacovigilance metrics for the site.
  • Developing collaborative relationships with cross-functional support and providing guidance on standard pharmacovigilance processes.
  • Support overall quality system programs as needed, including but not limited to training, supplier quality, change control, and deviation/CAPA systems.
  • Support cGMP compliance and inspection readiness within the organization.
  • Fosters the development of a Quality Culture within the cGMP environment.
  • Practice and promote a safety and quality mindset and excellence approach to all activities.
Basic Qualifications and Capabilities
  • Bachelor's degree with 4+ years of pharmacovigilance/complaints or related quality system experience within a regulated industry.
  • Strong organization, analytical, and execution skills with a proven track record of successfully managing multiple projects and priorities.
  • Excellent interpersonal, verbal, and written communication skills. Experience using various software/electronic applications required.
  • Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
  • Ability to work autonomously and within established guidelines, procedures, and practices.
  • Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
  • Continuously looking for opportunities to learn, build skills, and share knowledge with others. Experience in a process improvement environment.
  • Proactively identify and work collaboratively to resolve problems, taking risk-based and compliant approaches to solutions.

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