Manufacturing Visual Inspector II
2 weeks ago
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 Manufacturing Visual Inspector II will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site. The Petersburg site serves as Civica’s new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. Responsibilities of the position include performing visual inspections on filled product off the filling line following Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP).
Essential Duties and Responsibilities:
- Visually inspects finished product vials and syringes for various defects.
- Performs daily process activities, documents work accurately and timely in accordance with procedures, batch records and cGMPs.
- Set up and adjusts operating equipment, such as inspection machines in accordance with procedures.
- Performs and documents quality checks on products.
- Calculates percent defects on inspection results and reconciles components.
- Ability to complete eye exam and complete inspection certification.
- Assists other process functions as required.
- Proactively identify and work collaboratively to resolve problems.
Basic Qualifications and Capabilities:
- High School diploma or equivalent is required.
- Must be able to complete eye exam.
- 2+ years of experience performing inspections in a GMP environment.
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
- Effective organization skills and attention to detail.
- Must be able to understand, speak, and write English in order to comply with necessary SOPs, SPECs, Job-specific training materials, GMPs, and other manuals.
- Basic math skills to perform required calculations (multiplication/division),
- Visual ability to detect defects.
- Good written and oral communication skills.
- Ability to work autonomously and within established guidelines, procedures, and practices.
- Overtime, weekends and schedule adjustments may be required.
Preferred Qualifications:
- Experience in a sterile fill finish facility.
- Visual inspection experience of vials and syringes.
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