Quality Assurance Shop Floor Tech - 1st shift

Quality Assurance Shop Floor Tech - 1st shift (365)

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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. 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, Civica has partnered with nearly 60 health systems, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica supplies medicines to health system members in 49 states. Civica’s mission has expanded to reach consumers directly through CivicaScript, which aims to make quality outpatient generic medicines affordable and available. Civica is building a new manufacturing facility in Virginia to produce sterile injectables and biosimilars to improve access to affordable medications.

Civica is an Equal Opportunity Employer and complies with applicable laws.

The Quality Shop Floor Associate will join the Civica, Inc. ("Civica") Quality organization at the Petersburg, Virginia site by applying their knowledge and experience to support quality and compliance on the shop floor. The Petersburg site serves as Civica’s new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

Responsibilities 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 meet or exceed FDA requirements.

• 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 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.
• Work across functions to 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 in 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 good documentation practices are followed and the principles of ALCOA+ are adhered to according to regulatory guidelines and Civica’s SOPs.
• Maintain current knowledge of FDA and Civica requirements to keep pace with evolving manufacturing requirements.
• 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.
• 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 and collaborating with others to overcome challenges.
• Continual learner with willingness to build skills and share knowledge.

• Experience 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. The employee is regularly required to speak or hear; use hands or fingers to handle or feel objects, tools, or controls; stand, walk, sit, and reach with hands and arms.

The employee may occasionally lift and/or move up to 25 pounds. Specific vision abilities include close and distance vision and the ability to adjust focus. The noise level is usually low to moderate. Use of a pallet-jack or motorized walking stack may be required with proper training.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.

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