BioSpace, Inc.
Training Specialist (923)
BioSpace, Inc., Virginia State University, Virginia, us, 23806
Job Details
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 Training 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 and biosimilar insulin sterile injectable medications.
Responsibilities of the position include establishing and maintaining quality and compliance processes associated with training and development to ensure requirements for Good Manufacturing Practices (GMPs), are being met from the onset of building and qualifying the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
Essential Duties and Responsibilities:Design, develop and coordinate training program needs.Develop and/or review and maintain site curriculums and training requirements in the Veeva Electronic Learning Management System (EDMS).Act as a subject matter expert for the Veeva EDMS.Collaborate across functional areas to develop and align the site training requirements.Ensure that all training requirements and curriculum is reviewed within required intervals.Ensure GMP training documentation is maintained and controlled per company procedures.Author procedural documents related to area of responsibility.Participate in activities to support regulatory agency inspections.Create dashboards and training reports within Veeva.Monitor, track, and trend training.Act as document control to route procedural documents in the Veeva EDMS to ensure accuracy, completeness, and alignment with procedures.Review new and revised procedures, ensuring document changes are implemented into Petersburg procedures.Support document control and other quality systems activities as needed.Minimum Qualifications (Knowledge, Skills, and Abilities)
A minimum of four years' experience in the pharmaceutical or medical device industries.Bachelor or associate level degree in Pharmaceutical Sciences, Biology or related field preferred. High School degree with 6+ years of experience of cGMP production experience may be considered.Strong project management, organization, and execution skills with ability to managing multiple projects and priorities.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; can learn by doing.Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.Continuously looking for opportunities to learn, build skills and share knowledge with others.Preferred Qualifications:
Experience with Veeva.Yellow belt certification.
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 Training 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 and biosimilar insulin sterile injectable medications.
Responsibilities of the position include establishing and maintaining quality and compliance processes associated with training and development to ensure requirements for Good Manufacturing Practices (GMPs), are being met from the onset of building and qualifying the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
Essential Duties and Responsibilities:Design, develop and coordinate training program needs.Develop and/or review and maintain site curriculums and training requirements in the Veeva Electronic Learning Management System (EDMS).Act as a subject matter expert for the Veeva EDMS.Collaborate across functional areas to develop and align the site training requirements.Ensure that all training requirements and curriculum is reviewed within required intervals.Ensure GMP training documentation is maintained and controlled per company procedures.Author procedural documents related to area of responsibility.Participate in activities to support regulatory agency inspections.Create dashboards and training reports within Veeva.Monitor, track, and trend training.Act as document control to route procedural documents in the Veeva EDMS to ensure accuracy, completeness, and alignment with procedures.Review new and revised procedures, ensuring document changes are implemented into Petersburg procedures.Support document control and other quality systems activities as needed.Minimum Qualifications (Knowledge, Skills, and Abilities)
A minimum of four years' experience in the pharmaceutical or medical device industries.Bachelor or associate level degree in Pharmaceutical Sciences, Biology or related field preferred. High School degree with 6+ years of experience of cGMP production experience may be considered.Strong project management, organization, and execution skills with ability to managing multiple projects and priorities.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; can learn by doing.Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.Continuously looking for opportunities to learn, build skills and share knowledge with others.Preferred Qualifications:
Experience with Veeva.Yellow belt certification.