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 Manufacturing Specialist Lead, Visual Inspection, 2nd shift will play a key part in the facility start-up. Primary responsibilities will focus on supporting daily manufacturing visual inspection operations and ensuring product quality at the pharmaceutical manufacturing site. This critical position will support manufacturing production execution, visual inspection processes, equipment operation, change management, investigations, training, and development. The ideal candidate will have a consistent track record of achieving results in a precise, detail-oriented manufacturing environment.
Essential Duties and Responsibilities:
Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety, and other cross-functional teams to meet visual inspection and product quality requirements.
Provide comprehensive technical training for Visual Inspection Operators on manual inspection procedures, defect classification, and quality assessment techniques.
Develop and maintain Inspection Test Sets to ensure consistent and accurate product evaluation.
Conduct and lead detailed product defect investigations, including root cause analysis and product impact assessment.
Implement and manage the visual inspection defect tracking system to document and analyze inspection findings.
Drive the creation, revision, and management of visual inspection-related documents such as Standard Operating Procedures (SOPs) and batch records.
Oversee Acceptable Quality Limit (AQL) inspections with high precision and consistency.
Lead monthly audits and annual requalification of all personnel trained in manual visual inspection.
Adapt training methodologies to optimize learning outcomes for different team members.
Support onboarding and continuous development of visual inspection personnel.
Provide technical expertise in defect classification and product quality assessment.
Support regulatory inspections as a Subject Matter Expert (SME) for visual inspection processes.
Basic Qualifications and Capabilities:
A minimum of four+ years' experience in biopharmaceutical manufacturing in a GMP environment.
An associate's degree or higher in Pharmaceutical Sciences, Biology, or a related field is preferred
Extensive experience in pharmaceutical visual inspection processes.
Correctable 20/20 vision with no color blindness.
Ability to work in low-light inspection environments.
Detailed-oriented with exceptional accuracy in product defect identification and documentation.
Proficiency in Microsoft Office suite and electronic tracking systems.
Strong communication and collaboration skills, committed to maintaining the highest quality standards.
Ability to perform precise mathematical calculations (percentages, multiplication/division).
Skilled in writing comprehensive investigation reports and procedures.
Self-motivated, flexible, and able to work in a fast-paced, dynamic manufacturing environment.
Ability to stand for extended periods and perform repetitive physical tasks.
Preferred Qualifications:
Previous experience as an Inspection Operator or Line Coordinator.
Knowledge of defect kit creation and visual inspection technologies.
Experience with single-use components in drug product formulation.
Proficiency in Enterprise Resource Planning (ERP) systems.
Additional Requirements:
Must be able to work occasional weekend, or alternative shifts.
Requires on-site presence with significant time on the manufacturing floor.
Must be able to interact effectively with packaging colleagues and front-line leaders.
Physical Demands and Work Environment:
The physical demands described here represent those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
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. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.
The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.
