![Civica Rx](https://media.trabajo.org/img/noimg.jpg)
Manager QA Operations
1 month 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 Manager Quality Assurance (QA) Operations 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 sterile manufacturing and operations to ensure requirements for Good Manufacturing Practices (GMPs), are being met leading to a successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
Responsibilities also include, but are not limited to, quality disposition of incoming materials and finished drug product, shop floor oversight and the generation, review and/or approval of procedures, reports, batch records and other records necessary to support the design, implementation, and maintenance of manufacturing processes that meets or exceeds FDA requirements.
Essential Duties and Responsibilities:
- Provide leadership, direction, and support to the people within the Quality Assurance Operations department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
- Maintain current knowledge of regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
- Ensure procedural documents, manufacturing batch records and process within the manufacturing operations are in accordance with FDA regulations and GMPs.
- Responsible for approving raw materials, excipients, APIs and components material qualifications.
- Responsible for ensuring that all components, raw materials, excipients, drug product containers, closures, in-process materials, packaging material, labelling and drug products are released in accordance with the registered specifications.
- Responsible for Quality shop-floor oversight including real-time batch record review, response to deviations and implementation of corrective actions.
- Responsible for labeling processes and management.
- Responsible for disposition of drug products.
- 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 or lead in quality risk analysis process transfers.
- Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
- Promote a quality mindset and quality excellence approach to all activities.
- Promote a safety mindset and focus on safety for all operations activities.
- Maintain written procedures for personnel qualification and training and support the delivery of compliance training sessions.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- 8+ years’ experience working directly with manufacturing in the sterile injectable pharmaceutical and packaging operations.
- Bachelor-level or higher education.
- Project management, organization, and execution skills are required.
- Ability to apply technical expertise to solve problems and issues.
- Experience with technology transfers and new product introduction.
- Knowledge of data integrity controls in a manufacturing setting.
- Participation and leading activities to support regulatory agency inspections required.
- Minimum of 3 years’ experience in a supervisory role.
- 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, 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 in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
- Experience with isolator technology.
- Experience with combination products.
We have other current jobs related to this field that you can find below
-
QA/QC Engineer
2 weeks ago
Fort Gregg-Adams, United States AV3 Inc Full timeAV3, Inc. is a small, Native American and Veteran owned Audiovisual (AV) Systems Integration company. Our premiere organization is growing, and we are looking for true Leaders in around the Carolinas and Georgia. We’ve earned a gold star reputation serving the Intelligence and Defense communities, Public School Systems, and diversified, worldwide...
-
Operations Specialist
3 weeks ago
Fort Gregg-Adams, United States Advanced Technology Leaders Inc Full timeEssential Job Functions:Operations Specialists at the Company level will maintain/manage personnel files and training records on Army Logistics University student providing oversight of student records. The Operations Specialists will brief new students during in and out processing of the classes briefing unit procedures, schedules, and processes. Operations...
-
Operations Specialist
4 weeks ago
Fort Gregg-Adams, United States Advanced Technology Leaders Inc Full timeEssential Job Functions: Operations Specialists at the Company level will maintain/manage personnel files and training records on Army Logistics University student providing oversight of student records. The Operations Specialists will brief new students during in and out processing of the classes briefing unit procedures, schedules, and processes....
-
Recreation Aid
2 months ago
Fort Gregg-Adams, United States Department Of The Army Part timeSummary This position is located at Fort Gregg-Adams, VA - Outdoor Recreation. To better expedite the hiring process, we recommend including full contact information (name, address, phone number, email, etc.) for professional and personal references on your resume. *This is a...
-
Tosca QA Lead
4 weeks ago
Fort Lauderdale, United States Pursuit Software Full timeJob Title: Tosca QA Lead Location: Fort Lauderdale, Florida Position Overview: We are seeking a highly skilled Tosca QA Lead to join our dynamic team. The ideal candidate will have extensive experience in test automation using Tosca and a proven track record of leading QA teams in delivering successful projects. Key Responsibilities: Lead and mentor a...
-
QA Manager
3 months ago
Fort Worth, United States Resource Edge LLC Full timeJob DescriptionJob DescriptionResponsible for leading quality engineering team and quality process in a dynamic Agile environment. Champion for establishing a quality engineering process aligned with the wider organizational strategy and leading a team that promotes customer satisfaction which positively impacts the financial performance. Drive continuous...
-
Tosca QA Lead
4 weeks ago
Fort Lauderdale, United States Pursuit Software Full timeJob Title: Tosca QA LeadLocation: Fort Lauderdale, FloridaPosition Overview: We are seeking a highly skilled Tosca QA Lead to join our dynamic team. The ideal candidate will have extensive experience in test automation using Tosca and a proven track record of leading QA teams in delivering successful projects.Key Responsibilities:Lead and mentor a team of QA...
-
Tosca QA Lead
4 weeks ago
Fort Lauderdale, United States Pursuit Software Full timeJob Title: Tosca QA LeadLocation: Fort Lauderdale, FloridaPosition Overview: We are seeking a highly skilled Tosca QA Lead to join our dynamic team. The ideal candidate will have extensive experience in test automation using Tosca and a proven track record of leading QA teams in delivering successful projects.Key Responsibilities:Lead and mentor a team of QA...
-
Commissary Grocery Store/Project Manager
2 weeks ago
Fort Gregg-Adams, United States CW Resources, Inc. Full time $56,000CW Resources, part of CW Group Inc., is a proud member of the AbilityOne program designed to improve employment outcomes for people with significant disabilities. Shift: NightsCompany Overview:CW Resources is a national non-profit organization dedicated to creating an inclusive society where individuals with disabilities and those facing economic challenges...
-
Lead QA Engineer
1 day ago
Fort Lauderdale, United States TRAC Recruiting, Inc. Full timeAbout the job Lead QA Engineer (Hybrid) We are seeking a Lead QA Engineer for a full-time and direct hire role for one of our amazing partners in the Fort Lauderdale, FL area. This is a hybrid role that will require you to work onsite 3 days a week. You will help build an exciting new product that will revolutionize digital marketing at a fast-paced startup...
-
Grocery Store Supervisor
2 months ago
Fort Gregg-Adams, United States CW Resources, Inc. Full time $55,000 - $60,000CW Resources, part of CW Group Inc., is a proud member of the AbilityOne program designed to improve employment outcomes for people with significant disabilities. Company Overview: CW Resources is a national non-profit organization dedicated to creating an inclusive society where individuals with disabilities and those facing economic challenges have access...
-
Manager Manufacturing Cartridge/Pen
2 weeks ago
Fort Gregg-Adams, United States Civica Rx Full timeAbout 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...
-
Quality Assurance Technician
3 months ago
Fort McCoy, United States FM Meat Products LP Full timeAre you ready to step into the exciting world of food manufacturing and make a difference in quality assurance? Join our team at FM Meat Products LP as a Full Time Quality Assurance Technician (QA Tech) and embark on a thrilling journey that will challenge and develop your skills. As a QA Tech, you will play a crucial role in ensuring that our products meet...
-
Quality Assurance Technician
3 months ago
Fort McCoy, United States FM Meat Products LP Full timeJob DescriptionJob DescriptionAre you ready to step into the exciting world of food manufacturing and make a difference in quality assurance? Join our team at FM Meat Products LP as a Full Time Quality Assurance Technician (QA Tech) and embark on a thrilling journey that will challenge and develop your skills. As a QA Tech, you will play a crucial role in...
-
Software QA and Support Manager
4 weeks ago
Fort Worth, United States Bad Dog Games, LLC Full timeJob DescriptionJob DescriptionBecome a part of our Team! Bad Dog is a young market disruptor focused on building original gaming titles for regulated Skill and Class II gaming markets. We are a growing, collaborative team that works in a wide variety of game mechanics, themes, and styles that are as rewarding as they are challenging to create. If you are a...
-
Software QA and Support Manager
1 month ago
Fort Worth, United States Bad Dog Games, LLC Full timeJob DescriptionJob DescriptionBecome a part of our Team! Bad Dog is a young market disruptor focused on building original gaming titles for regulated Skill and Class II gaming markets. We are a growing, collaborative team that works in a wide variety of game mechanics, themes, and styles that are as rewarding as they are challenging to create. If you are a...
-
Software QA and Support Manager
3 weeks ago
Fort Worth, United States Bad Dog Games, LLC Full timeJob DescriptionJob DescriptionBecome a part of our Team! Bad Dog is a young market disruptor focused on building original gaming titles for regulated Skill and Class II gaming markets. We are a growing, collaborative team that works in a wide variety of game mechanics, themes, and styles that are as rewarding as they are challenging to create. If you are a...
-
Software QA and Support Manager
4 weeks ago
Fort Worth, United States Bad Dog Games, LLC Full timeJob DescriptionJob DescriptionBecome a part of our Team! Bad Dog is a young market disruptor focused on building original gaming titles for regulated Skill and Class II gaming markets. We are a growing, collaborative team that works in a wide variety of game mechanics, themes, and styles that are as rewarding as they are challenging to create. If you are a...
-
QA Specialist II – QA Shop Floor
3 months ago
Fort Worth, United States Smith+Nephew Full timeLife Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. The QA Specialist II – QA Shop Floor will provide quality oversight of operations through the quality approval of manufacturing procedures, batch records, and forms and quality sign off for process equipment/utilities calibration and preventative...
-
Cypress Automation QA
3 weeks ago
Fort Worth, United States Smart IT Frame Full timeRole: Cypress Automation QALocation: Hybrid in Fort Worth, TX (Day 1 Onsite)Duration: Long Term Interview Type: F2F in Fort Worth, TXJob Description: Responsibilities 8+ years of overall QA experience in Functional testing. 4-5 years or more hands on experience on Cypress automation with JavaScript or TypeScript. Knowledge of API Testing good to have....