Location: Petersburg, VA
Company: Civica Rx
They represent over 1,500 hospitals and one-third of all U. S. hospital beds. Civica has also begun to supply the U. S. Department of Veteran’s Affairs, the U. S. Department of Defense and the U. S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient shop space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life
sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone.
Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients. ” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica’s innovative model is directly impacting patient care, click
here to read a summary from the New England Journal of Medicine. ( catalyst.
nejm. org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Position Summary The Stability Associate 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.
The role is essential to assure the Petersburg site’s manufacturing and operations activities 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. Responsibilities of the position include working cross-functionally to establish and maintain the stability program at Civica Petersburg. Responsibilities also include but are not limited to the generation, review and/or approval of policies, procedures, reports, protocols, investigation, change controls and other records necessary for the stability program to ensure FDA requirements are met.
Essential Duties and Responsibilities Work across functions to support the development and maintenance of the stability program at Civica Petersburg. Author stability protocols for new drug products and annual commitment batches, as per current procedures and regulatory requirement. Support the shipment of samples to the appropriate external testing facilities. Work directly with Contract laboratories to coordinate and monitor testing schedules.
Track sample receipt, testing and obtain results and raw data from contract labs. Build and manage stability data in the LIMS system. Supports Annual Product Reviews and Annual Reports for existing products and provides relevant stability reports as needed. Support overall sample management and Quality Control Operations as needed. Compile stability metrics, trend data and report to Management. Ensure that all aspects of the handling, and manufacturing of medical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
Practice and promote a safety and quality mindset and a quality excellence approach to all activities. Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions. Minimum Qualifications (Knowledge, Skills, and Abilities) Bachelor’s degree in a scientific discipline with a minimum of 5 years Quality/CGMP experience in the medical industry. Experience in managing stability studies. Excellent written/oral communication skills with a strong discipline in Microsoft Programs is required. Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
Ability to work autonomously within established guidelines, procedures, and practices. Committed to delivering high quality results, overcoming challenges, and focusing on what matters. Continuously looking for opportunities to learn, build skills and share learning. Preferred Qualifications: Experience with Laboratory Information Management Systems (LIMS). Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
HR & Recruiting Jobs encompass a range of roles focused on managing an organization's human resources and talent acquisition processes. These positions play a crucial part in shaping company culture, ensuring employee satisfaction, and attracting top-tier candidates. Key responsibilities include developing hiring strategies, overseeing benefit programs, administering personnel policies, and ensuring compliance with labor laws. Characterized by strong interpersonal skills, HR and Recruiting professionals often act as liaisons between management and staff to foster a positive work environment. The field requires a blend of empathy, strategic thinking, and a keen understanding of employment regulations and best practices.
HR & Recruiting Jobs encompass a range of roles focused on managing an organization's human resources and talent acquisition processes. These positions play a crucial part in shaping company culture, ensuring employee satisfaction, and attracting top-tier candidates. Key responsibilities include developing hiring strategies, overseeing benefit programs, administering personnel policies, and ensuring compliance with labor laws. Characterized by strong interpersonal skills, HR and Recruiting professionals often act as liaisons between management and staff to foster a positive work environment. The field requires a blend of empathy, strategic thinking, and a keen understanding of employment regulations and best practices.
They represent over 1,500 hospitals and one-third of all U. S. hospital beds. Civica has also begun to supply the U. S. Department of Veteran’s Affairs, the U. S. Department of Defense and the U. S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient shop space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life
sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone.
Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients. ” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica’s innovative model is directly impacting patient care, click
here to read a summary from the New England Journal of Medicine. ( catalyst.
nejm. org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Job Description: The Head of Quality Systems leads the deployment and improvement of the Quality Management System (QMS) at Civica that ensures a high state of c GMP compliance and supports the effective execution of Civica objectives, including lifecycle management of policies and procedures for processes that govern all Gx P related activities.
Also, leads the following quality management systems: Documentation, Change Management, Investigation/Deviation and CAPA, Complaints, IT Quality, and Training. Additionally, is the owner of Electronic Systems associated with Documentation Management, Deviations/CAPA Management, Change Management and Learning Management. Essential Duties and Responsibilities: Establish, and maintain the global QMS elements including policies, processes, procedures and controls, enabling successful and efficient development and manufacturing of drug products meeting Civica and regulatory requirements.
Establish and maintain risk-based, fit-for-purpose Quality Management System. Oversee the pharmacovigilance program ensuring robust reporting and investigations. Responsible for the electronic quality management system (VEEVA) and ensuring the system maintains its validated state. Develop robust systems to assure corrective and preventive measures are systematically implemented and controlled. Propose and drive continuous improvements to the Quality Management System to streamline business processes and stay in compliance with external requirements (e. g. regulatory). Design and maintain trending program for quality events/ laboratory controls/ production controls by key indicators (e.
g. dates, categories, root causes, and CAPA) to identify adverse trends/ risk to help drive continuous improvement for manufacturing/ production controls and laboratory controls per Civica Gx P procedures. Ensure Computer System Validation (CSV) processes are fully implemented with the appropriate quality oversight. Develop and implement Medical Device Reporting (MDR) processes for combination products. Support and ensure the governance of any other initiatives as delegated. Establish and maintain Quality Plan.
Basic Qualifications and Capabilities: Minimum 15 years of life science/medical/biologics product manufacturing and development experience. Bachelor’s degree in a science, shop, or engineering discipline. Advanced degree desired. Broad knowledge and experience with quality assurance and quality system, regulatory compliance and understanding of current regulatory requirements and trends for manufacturing drug substance, drug product and combination products, in particular sterile injectable medications. Prior experience managing personnel. Working knowledge of software solutions for QMS.
Strong personal performance combined with demonstrated ability to build and lead highly engaged teams in a high growth environment. Strong project management skills with an emphasis on critical thinking and problem solving. Demonstrated ability to apply risk-based approaches to Quality Systems implementation, and maintenance. Extensive experience in hosting FDA inspections, keeping pace with ongoing updated regulations and requirements, and as applicable especially 21CFR211, 21CFR820/803/806.
They represent over 1,500 hospitals and one-third of all U. S. hospital beds. Civica has also begun to supply the U. S. Department of Veteran’s Affairs, the U. S. Department of Defense and the U. S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called Civica Script, to into the outpatient shop space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market.
The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life
sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications. Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone.
Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients. ” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway. To find out more about how Civica’s innovative model is directly impacting patient care, click
here to read a summary from the New England Journal of Medicine. ( catalyst.
nejm. org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in Bio Space. ( /article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Position Summary Advanced level Manufacturing Technician position with the responsibility to weigh and dispense active medical ingredients (API) and excipients in preparation of compounding. Compound bulk solutions for the filling operations and operate packaging equipment. Essential Duties and Responsibilities Under the Manufacturing Lead and/or Supervisor’s direction, support manufacturing operations to meet strategic department objectives.
Prepare cleaning and sanitizing solutions and perform daily, weekly, monthly cleaning of controlled and classified manufacturing areas. Replenish manufacturing components, materials, and supplies in all processing areas. Transport bright stock and finished product to and from staging as required according to manufacturing schedule. Perform equipment cleaning and preparation for sterilization. Operate sterilizer equipment to provide format parts for filling equipment. Clean, set up, and decontaminate material transfer isolator.
Clean, set up, and operate component processing equipment. Clean, set up, and operate terminal sterilizer equipment. Clean, set up, and operate weighing and compounding equipment. Weigh APIs and excipients according to batch record instructions. Compound bulk drug product per standard operating procedures and batch record instructions. Clean, set up, and operate packaging equipment. Adhere to Civica procedures and policies, conform to current good manufacturing practices and good documentation practices. Adhere to all safety regulations. Attend and participate in daily shift meetings to communicate events and issues to the manufacturing team.
Perform other duties as assigned by manufacturing management. Minimum Qualifications (Knowledge, Skills, and Abilities) • High school diploma or equivalent. Coursework or bachelor’s degree in a Life Science discipline preferred. • 2-3 years’ experience in medical manufacturing environment preferred. • Good reading and writing skills, and ability to perform basic to advanced mathematical calculations. • Ability to read, understand and follow written procedures.
