See more Collapse

Manager, Quality Engineering

2 months ago

Fort GreggAdams, United States Civica Rx Full time

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 Quality Assurance-Engineering Manager 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. Responsibilities of the position include establishing and maintaining quality systems and compliance oversight to ensure the facility, utilities, equipment, and computer systems meet cGMP and Civica compliance requirements at the onset of building 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.

The role is essential to assure the Petersburg site’s validation and qualification programs 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.

Essential Duties and Responsibilities:

  • Working across functions, to establish the site’s quality system processes related to GMP compliance of the facility, utilities, equipment, and computer systems.
  • Ensure the Quality oversight and review of validation and qualification activities for the site is performed including assurance that the appropriate resources, materials, and documentation are utilised, and that work is performed in a compliant and controlled manner.
  • Provide leadership, direction, and support to the people within the Quality Assurance Engineering 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 local and international 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.
  • Support and ensure compliance of product and process transfers, including validation, from other manufacturing sites.
  • 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.
  • Provide quality oversight for calibration and maintenance programs and ensure they are developed and run-in accordance with GMP regulation.
  • Manage the quality risk management process.
  • Support as needed process, method and cleaning validation.
  • Proactively identify and work collaboratively to resolve problems by 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.
  • Travel (up to 10%) may be required.

Basic Qualifications and Capabilities:

  • Bachelor’s degree in a scientific discipline with a minimum of 8 years Quality/CGMP management experience in the pharmaceutical industry. Experience in facility, utilities and equipment qualification, computer validation and calibration and maintenance programs.
  • Knowledge in 21CFR Part 11, Electronic Records and Signatures and data integrity is required.
  • Strong project management, organization, and execution skills with a proven track record of successfully managing multiple projects and priorities.
  • Quality management experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
  • Participation and leading activities to support regulatory agency inspections required.
  • 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:

  • Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices is highly desirable.
  • Process, method and cleaning validation.

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 time

    AV3, 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...

  • Engineering Manager

    2 months ago

    Adams, United States QPS Employment Group Full time

    Position Title: Engineering Manager Salary: Based on Experience We're seeking a results-oriented Engineering Manager to lead our team in delivering best-in-class process engineering projects. You'll oversee a team of engineers, driving continuous improvement through upgrades, root cause analysis, and capital project management. Responsibilities: - Manage...

  • Senior Quality Control Lead

    3 weeks ago

    Fort Meade, United States TAP Engineering Full time

    Job DescriptionJob DescriptionJob ID: TAP00115Position: Senior Quality Control LeadLocation: US – MD, Fort Meade (or surrounding area)Category: HardwareClearance Requirement: NoneEducation Requirement: High school degree or equivalentExperience Requirement: 7 YearsTAP is seeking to hire a Senior Quality Control Lead to join our team! If you are a highly...

  • Senior Quality Control Lead

    3 weeks ago

    Fort Meade, United States TAP Engineering Full time

    Job DescriptionJob DescriptionJob ID: TAP00101Position: Senior Quality Control LeadLocation: US – MD, Fort Meade (or surrounding area)Category: HardwareClearance Requirement: Active TS/SCI w/ polygraphEducation Requirement: High school degree or equivalentExperience Requirement: 7 YearsTAP is seeking to hire a Senior Quality Control Lead to join our team!...

  • Senior Quality Control Lead

    4 weeks ago

    Fort Meade, United States TAP Engineering Full time

    Job DescriptionJob DescriptionJob ID: TAP00101Position: Senior Quality Control LeadLocation: US – MD, Fort Meade (or surrounding area)Category: HardwareClearance Requirement: Active TS/SCI w/ polygraphEducation Requirement: NoneExperience Requirement: 7 YearsTAP is seeking to hire a Senior Quality Control Lead to join our team! If you are a highly...

  • Senior Quality Control Lead

    3 months ago

    Fort Meade, United States TAP Engineering Full time

    Job DescriptionJob DescriptionJob ID: TAP00101Position: Senior Quality Control LeadLocation: US – MD, Fort Meade (or surrounding area)Category: HardwareClearance Requirement: Active TS/SCI w/ polygraphEducation Requirement: NoneExperience Requirement: 7 YearsTAP is seeking to hire a Senior Quality Control Lead to join our team! If you are a highly...

  • Quality Control Engineer

    3 weeks ago

    Fort Wayne, United States Randstad Engineering US Full time

    A QA/QC Construction Coordinator is needed for a leading GC. The QA/QC Professional will oversee the implementation and management of the project quality control program. The role involves performing daily quality procedures, coordinating construction activities, and ensuring compliance with project standards and requirements. The ideal candidate will work...

  • CMT Project Manager

    3 weeks ago

    Fort Lauderdale, United States NOVA Engineering Full time

    Established in 1996, NOVA was originally founded to provide Environmental Consulting, Geotechnical Engineering, and Construction Materials Testing and Inspection services to the design and construction community, largely in the southeastern United States. Since our founding, NOVA has added additional service lines such as Facilities and Building Envelope,...

  • Quality Engineer

    2 weeks ago

    Fort Wayne, United States Dana Corporation Full time

    Job Purpose The purpose of the Quality Engineer is to work closely with design and production teams to quality issues. They respond to questions about how to achieve quality goals and implement changes to reduce the instance of errors. Job Duties and Responsibilities Responsible for the PPAP, Control Plans and GR&R for their respective areas. Support FMEA...

  • CMT Project Manager

    1 day ago

    Fort Lauderdale, United States NOVA Engineering Full time

    Established in 1996, NOVA was originally founded to provide Environmental Consulting, Geotechnical Engineering, and Construction Materials Testing and Inspection services to the design and construction community, largely in the southeastern United States. Since our founding, NOVA has added additional service lines such as Facilities and Building Envelope,...

  • Quality Engineer

    2 weeks ago

    Fort Lauderdale, United States Leeds Professional Resources Full time

    OverviewThe Quality Engineer, reporting to the Quality Manager, will provide technical expertise in process improvement initiatives using quality management principles and lean techniques. The primary objective is to prevent nonconforming products from reaching customers in accordance with corporate quality policy.ResponsibilitiesLead cross-functional...

  • Quality Engineer

    3 months ago

    Fort Wayne, United States BRC Rubber and Plastics Inc. Full time

    Job DescriptionJob DescriptionPOSITION SUMMARY: The Quality Engineer will take an active role in the implementation and maintenance of all quality system requirements including APQP, PPAP, customer concerns and customer visits, gauging, process control plans, supplier issues, IATF16969/ISO9001/ISO14001 elements, and customer specific...

  • Manager Manufacturing Cartridge/Pen

    2 weeks ago

    Fort Gregg-Adams, United States Civica Rx Full time

    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...

  • Commissary Grocery Store/Project Manager

    2 weeks ago

    Fort Gregg-Adams, United States CW Resources, Inc. Full time $56,000

    CW 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...

  • Quality Engineer

    2 weeks ago

    Fort Lauderdale, United States Leeds Professional Resources Full time

    Summary:Our client is looking for a Quality Engineer to bring technical expertise in performance excellence, Voice of the Customer, and process improvement efforts in order to prevent nonconforming products from reaching customers. Responsibilities:Proven ability to lead cross-functional problem-solving meetings with root cause analysis and corrective action...

  • Quality Engineer

    1 day ago

    Fort Lauderdale, United States Leeds Professional Resources Full time

    Summary:Our client is looking for a Quality Engineer to bring technical expertise in performance excellence, Voice of the Customer, and process improvement efforts in order to prevent nonconforming products from reaching customers. Responsibilities:Proven ability to lead cross-functional problem-solving meetings with root cause analysis and corrective action...

  • Principal Quality Engineer

    2 weeks ago

    Fort Worth, United States Elbit Systems Full time

    This is an experienced level position where the incumbent must possess an advanced level of quality engineering knowledge. Tasks at this level are in areas where technical requirements are of substantial complexity. The primary role of the Principal Quality Engineer, Quality, Principal, Engineer, Product Engineer, Project Management, Manufacturing,...

  • Quality Engineer

    1 month ago

    Fort Lauderdale, United States SONNY'S Enterprises Inc Full time

    Overview: Reporting to the Quality Manager, the Quality Engineer will provide technical expertise in performance excellence, Voice of the Customer (VOC), and process improvement efforts using quality management principles and lean techniques. This position follows corporate quality policy with the main objective of preventing nonconforming products from...

  • Grocery Store Supervisor

    2 months ago

    Fort Gregg-Adams, United States CW Resources, Inc. Full time $55,000 - $60,000

    CW 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...

  • Princ Quality Engineer

    2 weeks ago

    Fort Worth, United States Elbit Systems of America Full time

    Job Description This is an experienced level position where the incumbent must possess an advanced level of quality engineering knowledge. Tasks at this level are in areas where technical requirements are of substantial complexity. The primary role of the Principal Quality Engineer will be to identify, implement and measure success of a variety of Black Belt...