Sample Management Associate
Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration’s shortage list. Manufacturing challenges and predatory pricing are both the cause and result.
Who suffers most? Patients.
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. Led by an experienced team of health care and pharmaceutical industry leaders.
Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent 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 is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”
Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs.
To find out more about how Civica’s innovative model is directly impacting patient care, click here to read a recent article from the New England Journal of Medicine.
Intro to Civica
The Sample Management 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 supporting the establishment of sample management procedures and cGMP sample management activities for the Quality Control department. Responsibilities also include but are not limited to sample collection, retention, and sample oversight of the outsourced testing program.
Essential Duties and Responsibilities:
- Work across functions to support the development and maintenance of the sample management program.
- Ensure samples of incoming material are taken according to internal procedures.
- Ensure samples are stored according to the proper storage conditions and are stored securely per procedure and relevant FDA and controlled drugs are handled in accordance with Drug Enforcement Administration (DEA) regulatory requirements.
- Communicate, coordinate and ship samples to the appropriate external testing facilities for release and stability.
- Coordinate collection and storage and oversight of reserve samples.
- Receive and process results from external testing facility.
- Maintain a current list of samples with anticipated due dates for sample turnaround tracking. Communicate sample status effectively to supervisor.
- Maintain a separate storage location for sample lots under investigation.
- Conduct destruction of samples upon batch release from the Quality Control lab.
- Inventory and inspect raw material and finished product retention samples.
- Complete chemical inventory and ordering supplies as required.
- Conduct other duties as required to 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 taking risk-based and compliant approaches to solutions.
- Practice and promote a safety and quality mindset and quality excellence approach to all activities
- Travel limited but may occasionally be required.
Minimum Qualifications (Knowledge, Skills, and Abilities):
- Bachelor’s degree in a scientific discipline with a minimum of 3 years Quality/CGMP experience in the pharmaceutical industry.
- Excellent written/oral communication skills with a strong discipline in Microsoft Programs is required.
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
- Ability to work autonomously within established guidelines, procedures, and practices.
- Committed to delivering high quality results, overcoming challenges, and focusing on what matters.
- Continuously looking for opportunities to learn, build skills and share learning.
- Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
Physical Demand and Work Environment:
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. Specific vision abilities required by this position include color vision, close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.
The employee must have the ability to lift approximately 50 lbs, stand for 2 to 3 hours at a time, and walk long distances. Vision screening may be required.
The employee must have the capability to don gowning/PPE for entry into the aseptic core and supporting areas for extended periods of time. This will include standing, bending, reaching, kneeling, etc.