Current jobs related to Quality Systems Associate - US Petersburg VA USA - Civica Rx
-
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. Founded in 2018 by health systems and philanthropies, Civica Rx aims to ensure the consistent availability of affordable medications.With over 55 health systems on board, representing over...
-
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...
-
Quality Systems Specialist II for Data Integrity
3 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout CivicaCivica is a 501(c)(4) social welfare organization established to reduce chronic generic drug shortages and related high prices in the United States. The organization is led by an experienced team of healthcare and pharmaceutical industry leaders.Civica has partnered with over 55 health systems, representing over 1,500 hospitals and one-third of...
-
Quality Systems Specialist II for Data Integrity
3 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout CivicaCivica is a 501(c)(4) social welfare organization established to reduce chronic generic drug shortages and related high prices in the United States. The organization is led by an experienced team of healthcare and pharmaceutical industry leaders.Civica has formed a team at the Petersburg, Virginia site to oversee the manufacture and supply of...
-
Associate Director Quality Assurance Engineering
3 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeAbout CivicaCivica 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...
-
Associate Director, Quality Assurance Operations
3 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...
-
Quality Systems Specialist
4 weeks ago
Bloomington, MN, USA, United States Quality Tech Services, LLC Full timeJob SummaryWe are seeking a highly skilled Quality Systems Specialist to join our team at Quality Tech Services, LLC. As a Quality Systems Specialist, you will be responsible for developing, implementing, and maintaining our quality management system, ensuring compliance with ISO 13485 and FDA QSR regulations.Key ResponsibilitiesLead second and third-party...
-
Associate Quality Control Laboratory Analyst
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 deliver quality medicines that are available and affordable to everyone.Job Description:The Associate Quality Control Laboratory Analyst will play a critical role in ensuring...
-
Associate Quality Control Laboratory Analyst
3 weeks ago
US-, Petersburg, VA, USA 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 team of healthcare and pharmaceutical industry leaders is committed to delivering quality medicines that are available and affordable to everyone.The Associate Quality Control Laboratory...
-
Quality Systems Specialist
4 weeks ago
Bloomington, MN, USA, United States Quality Tech Services, LLC Full timeJob SummaryWe are seeking a highly skilled Quality Systems Specialist to join our team at Quality Tech Services, LLC. As a Quality Systems Specialist, you will be responsible for developing, implementing, and maintaining our quality management system, ensuring compliance with regulatory requirements and industry standards.Key ResponsibilitiesLead second and...
-
Quality Assurance Specialist
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.Job DescriptionThe QA Operations Specialist will...
-
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...
-
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...
-
Quality Systems Specialist II
4 weeks ago
Petersburg, United States BioSpace, Inc. Full timeAbout CivicaCivica is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Founded in 2018 by health systems and philanthropies, Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter.Job...
-
Quality Systems Specialist II
3 weeks ago
Petersburg, Virginia, United States Civica Rx Full timeJob SummaryCivica Rx is seeking a highly skilled Quality Systems Specialist II to join our team at the Petersburg, Virginia site. As a key member of our quality team, you will be responsible for overseeing our data governance program and ensuring appropriate data integrity controls are in place to protect data throughout the data lifecycle.Responsibilities-...
-
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 Specialist
4 weeks ago
US-, Petersburg, VA, USA Civica Rx Full timeJob Title: QA Operations SpecialistCivica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. As a QA Operations Specialist, you will play a critical role in ensuring the quality and compliance of our manufacturing processes.Key Responsibilities:Review and approve...
-
Quality Assurance Engineer
3 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. Since established, the #1 Policy for the Civica...
-
Quality Assurance Operations Supervisor
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 affordable, high-quality medications.Job DescriptionWe are seeking a Quality Assurance Operations Supervisor to join our team at our...
Quality Systems Associate
2 months ago
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. Founded in 2018 by health systems and philanthropies, Civica Rx aims to ensure the reliable supply of quality medicines.
With over 55 health systems and 1,500 hospitals on board, Civica Rx has made significant strides in addressing the issue of generic drug shortages. The organization has also supplied essential medicines to the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile.
Job Description:Quality Systems AssociateThe Quality Systems Associate will play a crucial role in ensuring the Petersburg site's Change Management Program complies with regulatory standards and expectations for the development and reliable supply of quality medicines.
Responsibilities include:
- Oversight of the quality management system (QMS) change management program
- Reviewing, editing, and approving change control documentation to ensure compliance with quality, regulatory, and SOP requirements
- Scheduling and facilitating cross-functional change control meetings and providing guidance and consultation to change control owners
- Facilitating, monitoring, and driving change control on-time completion
- Supporting overall quality system programs, including document control, supplier, and investigation systems
- Tracking, trending, and analyzing QMS information for the site
- Developing collaborative relationships with end users and providing guidance on standard processes in Change Control
- Acting as the site's subject matter expert on change control
- Partnering with members of the Quality Assurance team and/or end users of the system to promote continuous improvements to the Change Control system, process, and associated procedures
- Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation
- Supporting cGMP compliance and inspection readiness within the organization
- Proactively identifying and working collaboratively to resolve problems by taking risk-based and compliant approaches to solutions
- Fostering the development of a Quality Culture within the cGMP environment
- Practicing and promoting a safety and quality mindset and quality excellence approach to all activities
Basic Qualifications and Capabilities:
- Bachelor's degree with a minimum of 3 years document control experience within a regulated industry or a combination of equivalent education and experience
- Managed or participated in a cGMP Change Management program
- Strong organization, and execution skills with an attention to detail
- Ability to successfully manage multiple priorities
- Excellent interpersonal and written communication skills
- Experience with Electronic Documentation Management Systems
- 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
- Proactively identifying and working collaboratively to resolve problems by taking risk-based and compliant approaches to solutions
