Tracy Guldan

Role: Civica Rx
Location: Raleigh-Durham-Chapel Hill, NC, US
LinkedIn followers: 500 followers

OtherView LinkedIn profile

About Tracy Guldan

Quality and compliance professional delivering broad end-to-end GxP subject matter…

Experience

Civica Rx
Present

Skills

Capa
Regulatory Requirements
Validation
Regulatory Affairs
Life Sciences
Technology Transfer
Internal Audit
Quality Control
Gmp
Lims
Biotechnology
Standard Operating Procedure (Sop)
Cross-Functional Team Leadership
Computer System Validation
Auditing
U.s. Food and Drug Administration (Fda)
Microbiology
Laboratory Information Management System (Lims)
Pharmaceutical Industry
Sop
Fda
Quality Assurance
Regulatory Submissions
Change Control
Management
Biopharmaceuticals
Corrective and Preventive Action (Capa)
U.s. Title 21 Cfr Part 11 Regulation
Quality System
V&V
Cleaning Validation
Hplc
21 Cfr Part 11
Analytical Chemistry
Gxp
Quality Auditing
Aseptic Processing
Pharmaceutics

Contact information

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Work email
•••••@civicarx.org
Personal email
•••••@•••••.com
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Current company

Civica Rx

Pharmaceutical Manufacturing · 271 employees · Founded 2018 · Lehi, Utah, United States

Civica Rx was created in late 2018 to secure the supply of important medicines hospitals use every day. As of Q2 2024, we have provided over 180 million units of essential medicines to hospitals, enough to help treat over 80 million patients. Recently, we announced we will manufacture and distribute affordable medications for consumers in an outpatient/retail setting, including affordable insulin. Insulin is an exciting project as we are partnering with nearly every corner of the diabetes ecosystem to bring low-cost insulin to people living with diabetes at no more than $30 a vial and no more than $55 for a pack of five pre-filled pens, regardless of insurance status. WHY CIVICA? Because patients should have the essential medicines they need when they need them. As a rapidly growing, entrepreneurial, nonprofit generic drug company our mission is to ensure quality generic medicines are accessible and affordable to everyone.

civicarx.org

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