QA Shop Floor Tech, 1st Shift

Petersburg, VA Civica Rx

Job Description

The Quality Shop Floor Tech II 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.

Basic Qualifications and Capabilities:

• 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.

Preferred Qualifications:

• Experienced in the pharmaceutical industry.
• Quality Assurance experience.