Pharma Quality Assurance Floor Associate (2nd Shift)

Civica Rx; Petersburg (VA); On-site; USD 75,000 - 110,000; Full time

Job summary

Civica Rx in Petersburg, Virginia, seeks a Quality Assurance Operations Shop Floor Associate on 2nd shift to ensure cGMP compliance on the manufacturing floor of the fill-finish facility. You will oversee procedures, batch records, aseptic technique, and nonconformances, while collaborating with operators and supervisors to resolve discrepancies.

Ideal candidates have a science degree and 2+ years in a cGMP manufacturing environment, with experience in sterile isolator tech or medical devices,

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum of 2+ years of experience in pharmaceutical, biotech, cell therapy, or medical device cGMP manufacturing.
• Experience in sterile pharmaceutical isolator technology, combination products, or medical devices.
• Demonstrated experience delivering training on cGMP regulations, SOPs, and quality systems.
• Excellent written and verbal skills and ability to present technical data effectively.

Responsibilities

• Provide Quality Assurance oversight on the manufacturing floor during all operations regarding procedures, reports, batch records, aseptic technique, gowning, nonconformances, product sampling, and/or other records as necessary to support the manufacturing processes.
• On-the-floor review of batch records during execution to ensure compliance with approved procedures, and communicate and resolve discrepancies with operators and supervisors.
• Familiarity with electronic management systems such as Veeva, Deacom, and Blue Mountain RAM.
• Facilitate Quality oversight on the shop floor through walkthroughs, Gemba, and process observations to ensure full adherence to cGMP practices.
• Identify and implement improvements to procedures and processes as part of broader continuous improvement initiatives.
• Working across functions to ensure operational compliance in all aspects of product manufacturing.
• Enforcing adherence to all Civica SOPs while on the manufacturing floor.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operations activities.
• Ensure that on-the-floor review of manufacturing records, batch quantities, and accountability calculations are performed and completed accurately.
• 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, depending on job assignment and schedule.

Skills

QA oversight

Training delivery

cGMP regulations

Verbal communication

Education

Bachelor's degree in a scientific discipline

Tools

Veeva

Deacom

Blue Mountain RAM

Job description

Civica Rx in Petersburg, Virginia, seeks a Quality Assurance Operations Shop Floor Associate on 2nd shift to ensure cGMP compliance on the manufacturing floor of the fill-finish facility. You will oversee procedures, batch records, aseptic technique, and nonconformances, while collaborating with operators and supervisors to resolve discrepancies.

Ideal candidates have a science degree and 2+ years in a cGMP manufacturing environment, with experience in sterile isolator tech or medical devices,