Evening Operations Manager
7 days ago
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. S. hospital beds.
Department of Veteran's Affairs, the U.Department of Defense, and the U.Civicarecently announced plans to expand its mission, via a unit called CivicaScript, into the outpatient pharmacy space and to manufacture and distribute insulin 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 learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
The QA Operations Specialist 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 this position include, but are not limited to, Quality Operations review and approval of materials, bill of materials, batch records and GMP documentation to support the design, implementation, and maintenance of manufacturing processes that meets or exceed FDA requirements.
Support operational compliance aspects of sterile fill-finish manufacturing of products including but not limited to material, bill of material and executed batch record review and approval.
Working cross-functionally to determine defect criticality, inspection methods, and training plans for both QA Operations and Manufacturing employees.
Provide cross-functional support to MSAT and Operations in establishing process limits for manufacturing processes such as filling and packaging.
Lead or participate in Quality Risk Management Processes as needed.
Promote a safety and quality-first mindset in daily job functions.
Consistently represent the Quality Unit as a proactive and GxP-compliant team player when working with Operations in daily job duties.
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 receipt, quality control, chain of custody, disposition, and release of materials within the Enterprise Resource Planning system.Support, lead, or approve documents, change controls, investigations and CAPAs to support Civica's Quality Management System.
Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
Proactively be a team lead for department objectives with a minimal amount of supervision.
Includes complex project management that may overlap with other functional areas.
Support site objectives with a minimal amount of supervision.
Includes simple project management that may involve other functional areas.
Bachelor's degree with 4+ years of experience in a QA role in a cGMP production environment.
Associate degree with 6+ years of experience in a QA role in a cGMP production environment may be considered.
Participating in and leading activities that support regulatory agency inspections is required.
Project management, organization, and execution skills are 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.
Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
Technical expertise in sterile pharmaceutical isolator technology, combination products and medical devices is highly desirable.
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