Quality Assurance Associate

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 CivicaScript, 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 patient care, click here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Job Description

The Quality Assurance Associate 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.

The role is essential to assure the Petersburg site's manufacturing and operations activities comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines.

Responsibilities of the position include establishing and maintaining quality and compliance processes associated with sterile manufacturing and operations from the onset of building and qualifying the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

Responsibilities also include, but are not limited to, batch record development and review, approval of policies, procedures, reports, and other records necessary to support the design, implementation, and maintenance of manufacturing processes that meets or exceed FDA requirements.

Essential Duties and Responsibilities:

• Working across functions, establish and maintain the site's quality systems related to quality oversite of manufacturing operations to enable a reliable supply of quality generic medications to patients.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operations activities.
• Support operational compliance aspects of sterile fill-finish manufacturing of products including but not limited to batch record review and batch disposition,
• Ensure that all aspects of the handling, and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
• Support material and product disposition and quality control of material and products within the Enterprise Resource Planning system.
• Support supplier and material qualification program and establishment of a reduced testing program.
• Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.
• Support, review, and approve equipment qualifications and product and process transfers, including validation, from development and/or other manufacturing sites.
• Establish and maintain Standard Operating Procedures to ensure that all components, raw materials, excipients, drug product containers, closures, in-process materials, packaging material, labeling and drug products are released per the registered specifications.
• Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
• Participate in quality risk analysis.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
• Travel is limited but may occasionally be required.

Basic Qualifications and Capabilities:

• Bachelor's degree and 3 years Quality or cGMP experience working directly with manufacturing. in the pharmaceutical industry
• Strong project management, organization, and execution skills
• Participation and leading activities to support regulatory agency inspections required.
• 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.
• Continuously looking for opportunities to learn, build skills, and share knowledge with others.

Preferred Qualifications:

Technical expertise in sterile pharmaceutical isolator technology, combination products and medical devices is highly desirable.

Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.

About the Company:
Civica Rx