QA Operations Specialist

3 months ago

Petersburg, United States Civica Rx Full time

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. 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.

Civicarecently announced plans to expand its mission, via a unit called CivicaScript, into the outpatient pharmacy space and to manufacture and distribute insulin 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 NewEngland Journal of Medicine. (https://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 BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Job Description

The QA Operations Specialist 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 this position include, but are not limited to, Quality Operations review and approval of materials, bill of materials, batch records and GMP documentation to support the design, implementation, and maintenance of manufacturing processes that meets or exceed FDA requirements.

Essential Duties and Responsibilities:

  • Support operational compliance aspects of sterile fill-finish manufacturing of products including but not limited to material, bill of material and executed batch record review and approval.
  • Partner with operations to develop manufacturing batch records to be compliant with regulatory and company requirements.
  • Working cross-functionally to determine defect criticality, inspection methods, and training plans for both QA Operations and Manufacturing employees.
  • Provide cross-functional support to MSAT and Operations in establishing process limits for manufacturing processes such as filling and packaging.
  • Act as a resource for colleagues.
  • Lead or participate in Quality Risk Management Processes as needed.
  • Promote a safety and quality-first mindset in daily job functions.
  • Consistently represent the Quality Unit as a proactive and GxP-compliant team player when working with Operations in daily job duties.
  • Ensure that all aspects of the handling, and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
  • Support material receipt, quality control, chain of custody, disposition, and release of materials within the Enterprise Resource Planning system.
  • Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.
  • Support, lead, or approve documents, change controls, investigations and CAPAs to support Civica's Quality Management System.
  • Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
  • Proactively be a team lead for department objectives with a minimal amount of supervision.
    • Includes complex project management that may overlap with other functional areas.
  • Support site objectives with a minimal amount of supervision.
    • Includes simple project management that may involve other functional areas.

Basic Qualifications and Capabilities:

  • Bachelor's degree with 4+ years of experience in a QA role in a cGMP production environment.
  • Associate degree with 6+ years of experience in a QA role in a cGMP production environment may be considered.
  • Ability to apply technical expertise to solve problems and issues.
  • Participating in and leading activities that support regulatory agency inspections is required.
  • Project management, organization, and execution skills are 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:

  • Manufacturing Batch Record Design experience is highly desirable.
  • Technical expertise in sterile pharmaceutical isolator technology, combination products and medical devices is highly desirable.
  • Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
PandoLogic. Keywords: Operations Specialist, Location: Petersburg, VA - 23803 , PL: 594327221

  • QA Operations Specialist II

    3 months ago

    Petersburg, United States Civica Rx Full time

    About 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. They...

  • QA Manual

    6 months ago

    St Petersburg, United States Saxon Global Full time

    Review and refine test case scenarios in relation to all the existing systems an d their integrations to be on a par with everchanging integration landscape and upcoming projects and 2) Automate the run through all test cases to maximize the "quality" of QA given that the volume of test scenarios ever increases. Someone to find and fixes bugs in a product or...

  • QA Operations Manager

    3 months ago

    Petersburg, United States Civica Rx Full time

    About 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. They...

  • Civica Senior QA Operations Lead

    3 weeks ago

    Petersburg, United States Civica Full time

    Job Summary:We are seeking an experienced Civica Senior QA Operations Lead to join our team.About the Role:This is a unique opportunity to lead our Quality Assurance Operations department and ensure that they are qualified, achieve a high level of competence, and carry out their duties in a safe manner.Main Responsibilities:Maintain current knowledge of...

  • QA/RA Compliance Specialist

    3 weeks ago

    St Petersburg, United States Catalent Inc Full time

    QA/RA Compliance Specialist Position Summary St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year.  Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges. Catalent...

  • Pharmaceutical Quality Assurance Specialist

    3 weeks ago

    Petersburg, Virginia, United States Civica Rx Full time

    Civica Rx is a leading social welfare organization dedicated to reducing generic drug shortages and related high prices in the United States.As a QA Operations Specialist, you will join our team at the Petersburg, Virginia site and contribute to the manufacture and supply of essential generic sterile injectable medications.This role is critical in ensuring...

  • QA/RA Compliance Specialist

    3 weeks ago

    St Petersburg, United States Mindlance Full time

    Duration:0-6 month(s) ONSITE - DURATION - 6 MONTHS AND MAY EXTEND - SHIFT - MON-FRI 8AM - 5PM OR 9AM - 6PM. Education or Equivalent: • Bachelor's Degree in Science or related field required (Chemistry, Microbiology or Biology); • A minimum of 3 years related experience in the pharmaceutical manufacturing industry. • Strong background working with...

  • Industrial Operations Specialist

    2 weeks ago

    Petersburg, Virginia, United States Aerotek Full time

    About the RoleAerotek is seeking a highly skilled Industrial Operations Specialist to join our team in South Chesterfield, VA. As an Industrial Operations Specialist, you will be responsible for material handling and operating forklifts to transport materials.This is an exciting opportunity to work in a fast-paced manufacturing environment with a small plant...

  • Banking Operations Specialist

    3 days ago

    Saint Petersburg, United States Seacoast Bank Full time

    Job Title: Banking Operations SpecialistWe are seeking a detail-oriented Banking Operations Specialist to join our team at Seacoast Bank.Job Overview:The successful candidate will be responsible for supporting the Commercial Banking operations team, including coordinating the activities of assigned Bankers. This includes processing closed loans, preparing...

  • Logistics Yard Operations Specialist

    3 days ago

    Petersburg, United States PS Logistics Full time

    About the Role:PS Logistics is seeking a highly skilled Logistics Yard Operations Specialist to join our team. As a critical member of our operations, you will be responsible for transporting mill product via tractor/trailer, inspecting and operating equipment, and delivering loads promptly and securely.Key Responsibilities:Maintain and operate yard vehicles...

  • Manufacturing Operations Specialist

    2 weeks ago

    St. Petersburg, Florida, United States Sybridge Technologies Full time

    Job SummaryWe are seeking a skilled Manufacturing Operations Specialist to oversee the operation of injection molding machines on a given shift. The successful candidate will produce high-quality products that conform to part specifications, quality standards, and procedures.

  • Manufacturing Specialist

    2 weeks ago

    Petersburg, Virginia, United States Aerotek Full time

    Job SummaryAerotek is seeking a skilled Manufacturing Specialist to join our team in South Chesterfield, VA. This role will involve operating and maintaining Haas CNC lathe machines as well as some Haas CNC Mills.About the RoleOperate and maintain Haas CNC lathe machines and Haas CNC Mills.Read and interpret blueprints and technical drawings.Utilize...

  • Mobile Surgical Operation Specialist

    3 weeks ago

    St. Petersburg, Florida, United States beBee Professionals Full time $45,000 - $75,000

    At beBee Professionals, we are seeking a skilled and experienced Mobile Surgical Operation Specialist to assist in surgical operations by preparing operating rooms and ensuring all necessary instruments and equipment are available.Salary: $85,000 - $115,000 per annum, depending on experience and qualifications.Job Description:We are looking for a highly...

  • Annuity Care Operations Specialist

    2 weeks ago

    St Petersburg, United States Raymond James Financial Services Full time

    About the RoleWe are seeking a highly skilled Annuity Care Operations Specialist to join our team at Raymond James Financial Services.As an Annuity Care Operations Specialist, you will play a critical role in supporting the processing of annuity applications submitted by financial advisors/agents. Your responsibilities will include reviewing applications for...

  • Maritime Operations Specialist

    2 weeks ago

    St. Petersburg, Florida, United States SailFuture Full time

    Job OverviewSailFuture seeks a highly skilled and experienced Maritime Operations Specialist to join our crew for the 22-23 term. As a key member of our team, you will be responsible for ensuring the smooth operation and maintenance of our vessel, providing an exceptional experience for all passengers and crew.About the RoleThe successful candidate will have...

  • Operations Specialist

    7 months ago

    Petersburg, United States FactoryFix Full time

    Opportunity: HOTFO005798ESSENTIAL FUNCTIONSTo accomplish this job successfully, an individual must be able to perform each essential function satisfactorily. Adhere to plant-wide safety, ergonomics and environmental requirements, defined by Amsted Rail; outlined by the Amsted Rail Health & Safety program.Analyze job orders, drawings, blueprints and...

  • Senior Financial Operations Specialist

    2 weeks ago

    St Petersburg, United States Raymond James Financial Incorporated Full time

    About the RoleWe are seeking a highly skilled and experienced Senior Financial Operations Specialist to join our team at Raymond James Financial Incorporated. This is a unique opportunity to leverage your expertise in financial operations and work with a dynamic team to drive business growth.Job DescriptionThe successful candidate will be responsible for...

  • Administrative Operations Specialist

    2 weeks ago

    St. Petersburg, Florida, United States SailFuture Full time

    Empowering Youth through Administrative ExcellenceSailFuture, a non-profit organization dedicated to transforming the lives of hard-to-reach youth, seeks an administrative operations specialist to join our team.About SailFutureWe are passionate about empowering at-risk students to achieve economic freedom and social mobility through character development and...

  • Machinist Operations Specialist

    2 weeks ago

    St. Petersburg, Florida, United States Rev-Tech Manufacturing Solutions LLC Full time

    About Rev-Tech Manufacturing Solutions LLC">We are a leading manufacturer of precision parts and assemblies. Our company is committed to delivering high-quality products on time, while maintaining a safe and healthy work environment.">Job Summary">We are seeking an experienced Machinist Operations Specialist to join our team. The successful candidate will be...

  • Compliance Specialist with Regulatory Expertise

    2 weeks ago

    St Petersburg, United States Catalent Inc Full time

    Job Summary:Catalent Inc is seeking a highly skilled QA/RA Compliance Specialist to join our team in St. Petersburg, FL.About the Role:This is an exciting opportunity for a detail-oriented and organized professional to work closely with our manufacturing, engineering, product development, and technical services teams to ensure compliance with governmental...