Quality Shop Floor Associate

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 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 CivicaScript, to into the outpatient pharmacy 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.

(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 Quality Shop Floor 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. Responsibilities of the position include maintaining quality and compliance processes associated with sterile manufacturing and operations from the onset of building and qualifying the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

Ensure that the site and it's associated manufacturing operations are meeting the cGMP requirements. Responsibilities also include, but are not limited to: Shop Floor oversight, ERP processing, and the generation of procedures, reports, batch records, labels, nonconformances, 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: Working across functions, maintain the site's quality systems related to operations to enable reliable supply of quality generic medications to patients.

Promote a quality mindset and quality excellence approach to all activities. Promote a safety mindset and focus on safety for all operations activities. Responsible for operational compliance aspects of all manufacturing of products including but not limited to automated and manual product inspection, incoming inspection on raw materials and components, labeling control, issuance of nonconformances, inspection on finished goods, and enforcing adherence to all Civica standard operating procedures (SOPs) while on the manufacturing floor.

Ensure that real-time review of manufacturing records, batch quantities, and accountability calculations is performed and completed Provide immediate support in the identification and documentation of nonconformances, deviations, or discrepancies on the manufacturing floor Review and report any quality issues or shortages in inventory to QA and Production management, especially for controlled substances Provide support as required to all manufacturing and processing areas within the facility, depending on job assignment and schedule. Ensure that all aspects of processing and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements. 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. Provide training on inspection techniques or best practices to other Quality or Production employees as required Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing. Support testing for equipment qualifications and product and process transfers, from development and/or other manufacturing sites.

Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions. Basic Qualifications and Capabilities: Bachelor's degree in a scientific discipline or a minimum of 4 years Quality/CGMP experience in the pharmaceutical industry. Experience in sterile injectable manufacturing and packaging operations is preferred.

Equivalent experience and education can be used. Strong organization and execution skills Experience in performing incoming inspections highly desired Experienced in the use of standard operating procedures relative to GMP or GLP highly desired 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: Experience in sterile pharmaceutical isolator technology, combination product and medical devices Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances Prior experience in a pharmaceutical, aerospace, medical device, or other applicable industry