Associate Director Quality Assurance Engineering
3 weeks ago
Civica is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our team of experienced health care and pharmaceutical industry leaders is committed to ensuring the consistent availability of affordable medications.
As a key member of our team, the Associate Director, Quality Assurance - Engineering will play a critical role in establishing and maintaining quality systems and compliance oversight to ensure the validation/qualification and operation of processes, facility, equipment, and computer systems meet cGMP and Civica requirements.
Responsibilities- Provide leadership, direction, and support to the Quality Assurance Engineering team to ensure they are qualified to achieve a high level of competence and motivated to carry out their duties in a safe manner.
- Establish and maintain the site's quality system processes related to GMP compliance of the facility, equipment, computer systems, and manufacturing processes.
- Ensure the Quality oversight and review of validation and qualification activities and documentation for the site is performed, including assurance that the appropriate resources, materials, and documentation are utilized, and that work is performed in a compliant and controlled 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.
- Ensure implementation and quality oversight related to the overall compliance of the facility, utilities, equipment, and manufacturing processes.
- Lead operational and inspection readiness for Health Agency inspections.
- Support quality processes and systems across the product lifecycle, including 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.
- Participate or lead in quality risk analysis/assessments.
- Participate or lead the assessment, qualification, and approval of suppliers.
- Proactively identify and work collaboratively to resolve problems, taking risk-based and compliant approaches to solutions.
- Lead and participate in deviation investigations as necessary.
- 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.
- Participate in and/or lead health authority (primarily FDA and E.U.) agency inspections at the site.
This is a challenging and rewarding role that requires a strong background in quality assurance and a passion for ensuring the highest level of quality and compliance in the manufacture of essential generic sterile and biosimilar injectable medications.
Civica offers a dynamic and collaborative work environment, with opportunities for professional growth and development. If you are a motivated and experienced quality professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
-
Associate Director, Quality Assurance
4 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to essential medications at affordable prices.Job Description:We are seeking an experienced Associate Director, Quality Assurance to join our...
-
Associate Director, Quality Assurance Operations
4 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our team of experienced health care and pharmaceutical industry leaders is committed to ensuring the reliable supply of quality medicines to patients.We are seeking an Associate Director,...
-
Associate Director, Quality Assurance Operations
4 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to essential medications, and we are committed to delivering high-quality, affordable products.Job Description:We are seeking an experienced...
-
Associate Director, Quality Assurance
4 weeks ago
Petersburg, United States Civica Rx Full timeAbout the RoleCivica Rx is seeking an experienced Associate Director, Quality Assurance - Engineering to join our team at our Petersburg, Virginia site. As a key member of our quality team, you will be responsible for establishing and maintaining quality systems and compliance oversight to ensure the validation/qualification and operation of processes,...
-
Associate Director, Quality Assurance
3 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica Rx:Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States.Our mission is to improve patient access to affordable medications, and we are committed to delivering high-quality results while working with...
-
Quality Assurance Engineer
4 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.We are led by an experienced team of healthcare...
-
Associate Director, Quality Assurance
2 months ago
Petersburg, 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 sterile...
-
Associate Director, Quality Assurance
4 weeks ago
Petersburg, Virginia, United States Civica Rx Full timeAbout Civica RxCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to provide essential generic sterile and biosimilar injectable medications to patients in need.Job DescriptionThe Associate Director, Quality Assurance - Engineering will join...
-
Associate Director, Quality Assurance
4 weeks ago
Petersburg, United States Civica Rx Full timeAbout the RoleCivica Rx is seeking an experienced Associate Director, Quality Assurance to join our team at our Petersburg, Virginia site. As a key member of our quality assurance operations team, you will be responsible for establishing and maintaining quality systems and compliance oversight of manufacturing operations to ensure medications manufactured...
-
Associate Director, Quality Assurance Lead
4 weeks ago
Petersburg, United States Civica Rx Full timeAbout Civica Rx:Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to provide essential generic sterile and biosimilar injectable medications to patients in need.We are seeking an experienced Associate Director, Quality Assurance to join our...
-
Director of Quality Assurance Leadership
4 weeks ago
Petersburg, Virginia, United States Sterling Life Sciences Full timeJob Summary Sterling Life Sciences is seeking a highly skilled Associate Director of Quality Assurance to lead the Quality Assurance Team. The ideal candidate will have a strong background in quality assurance management and a passion for driving excellence in the pharmaceutical industry. Key Responsibilities: 1. Review and approve quality system records,...
-
Quality Assurance Engineer
4 weeks ago
Petersburg, United States BioSpace, Inc. Full timeAbout the RoleCivica is seeking a Quality Assurance Engineer to join our team at our Petersburg, Virginia site. As a Quality Assurance Engineer, you will be responsible for maintaining quality systems and oversight to ensure the validation/qualification and operation of computerized systems meet cGMP and Civica compliance requirements.The ideal candidate...
-
Associate Director, Quality Assurance
1 month ago
Petersburg, 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 sterile...
-
Associate Director, Quality Assurance
2 months ago
Petersburg, 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 sterile...
-
Quality Assurance Engineer
2 weeks ago
Petersburg, VA, United States Civica Rx Full timeAbout Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. S....
-
Quality Assurance Director
2 months ago
Alpharetta, GA, USA, United States CorDx Full timeJob Title: Quality Assurance DirectorCorDx is seeking an experienced Quality Assurance Director to lead our quality assurance team in the development, manufacturing, and distribution of Class II IVD devices.Key Responsibilities:Develop and implement quality assurance strategies to ensure compliance with FDA, ISO 13485, and other relevant regulatory...
-
Quality Assurance Specialist
3 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our team of experienced healthcare and pharmaceutical industry leaders is committed to ensuring that quality generic medications are accessible and affordable to everyone.The QA Operations Specialist will...
-
Quality Assurance Engineer
4 weeks ago
Lynchburg, VA , USA, United States L3 Technologies Full timeJob Title: Assoc, Quality EngineeringJob Code: 13702Job Location: Lynchburg, VAJob Summary:As a Quality Assurance Engineer at L3 Technologies, you will be responsible for developing and implementing quality processes and procedures using statistical quality control statistics and analyses. You will collaborate with internal and external customers to ensure...
-
Director of Quality Assurance
4 weeks ago
Miami, FL , USA, United States AAR Full timeJob SummaryAs a Director of Quality Assurance at AAR, you will be responsible for directing visual and electronic, electrical and mechanical inspection and testing of parts and products. You will develop and implement goals and objectives for in-process tests and controls to meet and maintain minimum defect levels while improving overall quality and customer...
-
Quality Assurance Specialist
4 weeks ago
US-, Kansas, OK, USA Kelly Science, Engineering, Technology & Telecom Full timeJob SummaryWe are seeking a skilled Quality Assurance Specialist to join our team at Kelly Science, Engineering, Technology & Telecom. In this role, you will be responsible for conducting comprehensive analyses on raw materials, in-process products, and finished goods.Key ResponsibilitiesTesting and Analysis: Conduct thorough testing and analysis of raw...
