What are the responsibilities and job description for the Quality Assurance Shop Floor Tech (365) position at BioSpace?
About Civica
Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.
Shortages put patients at risk and waste hospital resources.
Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.
Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.
Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.
The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.
Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.
Join us. Learn more at www.civicarx.org
Job Description
The Quality Shop Floor Associate will join the Civica, Inc. (“Civica”) Quality organization 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 quality shop floor support, manufacturing documentation review, and the generation of procedures, chain of custody documents, or other records necessary to support the design, implementation, and maintenance of manufacturing processes that meets or exceeds FDA requirements.
Essential Duties And Responsibilities
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. Additionally, use of a pallet-jack or motorized walking stack may be required with appropriate training.
The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.
Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.
Shortages put patients at risk and waste hospital resources.
Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.
Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.
Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.
The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.
Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.
Join us. Learn more at www.civicarx.org
Job Description
The Quality Shop Floor Associate will join the Civica, Inc. (“Civica”) Quality organization 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 quality shop floor support, manufacturing documentation review, and the generation of procedures, chain of custody documents, or other records necessary to support the design, implementation, and maintenance of manufacturing processes that meets or exceeds FDA requirements.
Essential Duties And Responsibilities
- Perform quality review of materials and components received.
- Perform inspection on finished goods.
- Ensure adherence to Civica standard operating procedures (SOPs) and batch records while on the manufacturing floor.
- Ensure that real-time review of manufacturing records and cleaning records.
- Provide immediate support in the identification and documentation of nonconformances, deviations, or discrepancies on the manufacturing floor.
- Provide support as required to all manufacturing and processing areas within the facility.
- Working across functions, maintain the site’s quality systems related to operations to enable reliable supply of quality generic medications to patients.
- Support manual visual inspection of filled products.
- Promote a quality mindset and quality excellence approach to all activities.
- Promote a safety mindset and focus on safety for all operations activities.
- Maintain SOPs and training to stay up to date with cGMPs for QA shop-floor support.
- Ensure that good documentation practices are followed and that the principles of ALCOA are followed in accordance with regulatory guidelines and Civica’s SOPs.
- Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.
- Proactively identify and work collaboratively to resolve problems.
- High school diploma.
- Strong organization and execution skills.
- 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.
- Experienced in the pharmaceutical industry.
- Quality Assurance experience.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate. Additionally, use of a pallet-jack or motorized walking stack may be required with appropriate training.
The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.
