- Manages Veeva LIMS Vault.
- Implement and monitor data integrity controls to ensure the laboratory data's accuracy, completeness, consistency, and availability.
- Creates and Maintains User Accounts.
- Builds and manages static data.
- Develops and implements ongoing training.
- Ensures controls related to approval levels and user access are established and maintained.
- Manages user inquiries for troubleshooting and resolves issues.
- Proactively identifies and works to resolve project and system issues.
- Ensures Veeva Vault conforms to regulatory requirements.
- Oversees and participates in the development of application documentation.
- Works in coordination with business stakeholders to develop and prepare reports, metrics, and dashboards.
- Works closely with various business stakeholders to lead and manage business requirements and system solution delivery.
- Manages ongoing maintenance and enhancements (i.e. new releases)
- Drive improvements and efficiencies.
- Supports adding vault capabilities as identified by the business.
- A bachelor's degree in chemistry, engineering, or a related field with 6+ years of experience with LIMS in the pharmaceutical or biotechnology industry.
- Excellent interpersonal and written communication skills and 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.
- Proven experience in leading and deploying LIMS.
- Experience implementing data integrity controls.
- In depth knowledge of Quality Assurance/Quality Control Operations.
- Experience with system design and development starting from business requirements analysis through implementation and support.
- Strong knowledge of computerized system validation
- Experience with ELN and implementation of paperless lab.
- A strong knowledge of the computerized system principles, standards, and regulations, such as GAMP 5, 21 CFR Part 11, EU Annex 11, etc.
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Quality Specialist II - Petersburg, United States - Civica Rx
Description
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 represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.
Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica's affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.
Civica's mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients." Civica's manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.
To find out more about how Civica's innovative model is directly impacting patientcare, click here to read a summary from the New England Journal of Medicine. )
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
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Job Description:
The Quality Specialist II - Veeva LIMS Administrator will join the Civica, Inc. ("Civica") organization and its newly forming team at the Petersburg, Virginia site by 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.
This position is responsible for the implementation, management, and ongoing maintenance of the Veeva Laboratory Information Management System (LIMS) Vault used at Civica.
Shift: Day Shift. Monday through Friday.
Essential Duties and Responsibilities:
Basic Qualifications and Capabilities:
Preferred Qualifications:
