QA Operations Specialist II (906)
Civica

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica's plans and progress at www.civicarx.org

Job Description

The QA Operations Specialist II 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 for insulin, biologics or biosimilar medicines that meets or exceed FDA requirements.

Essential Duties and Responsibilities:

• Support operational compliance aspects of sterile fill-finish manufacturing of insulin and biologics or biosimilar small molecule products including but not limited to material, bill of material and executed batch record review and approval.
• Partner with operations to develop manufacturing batch records to be compliant with regulatory and company requirements.
• Working cross-functionally to determine defect criticality, inspection methods, and training plans for both QA Operations and Manufacturing employees.
• Act as a resource for colleagues.
• 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.
• Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.
• 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.
• Travel is limited but may occasionally be required.

• 6 years' experience working directly with manufacturing in the pharmaceutical or medical device industries. Appropriate combinations of experience and bachelor-level or higher education.
• Project management, organization, and execution skills are required.
• Ability to apply technical expertise to solve problems and issues.
• Participating in and leading activities that support regulatory agency inspections is 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, customer focused, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills, and share knowledge with others.

• Manufacturing Batch Record Design experience is highly desirable.
• 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.