Quality Assurance Associate

RXinsider LTD.; Petersburg (VA); On-site; USD 65,000 - 90,000; Full time

Job summary

Civica in Petersburg, VA is seeking a Quality Assurance Operations Shop Floor Associate to support cGMP manufacturing on the sterile fill-finish line. You will oversee QA activities on the floor, review batch records, ensure procedures are followed, and help maintain quality across manufacturing operations.

The role requires a Bachelor's degree in a scientific field and at least 2 years in a regulated pharma/biotech environment, with experience in sterile isolator tech, SOPs, and quality

Qualifications

• Bachelor's degree in a scientific discipline or higher.
• Minimum 2+ years in a pharmaceutical/biotech/cGMP-regulated manufacturing environment.
• Experience with 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 with the ability to present technical data to diverse audiences.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Detail-oriented and task-focused with ability to meet deadlines.

Responsibilities

• Provide QA oversight on the manufacturing floor during operations including procedures, batch records, aseptic technique, gowning, nonconformances, and sampling.
• On-the-floor review of batch records to ensure compliance and resolve discrepancies with operators or supervisors.
• Familiarity with electronic management systems (Veeva, Deacom, Blue Mountain RAM).
• Facilitate QA oversight through walkthroughs, Gemba, and observations to ensure cGMP compliance.
• Identify and implement procedure/process improvements as part of continuous improvement initiatives.
• Work across functions to ensure operational compliance in product manufacturing and adherence to SOPs.

Skills

Quality Assurance

cGMP knowledge

Written communication

Verbal communication

Training delivery

Education

Bachelor's degree in scientific field

Tools

Veeva

Deacom

Blue Mountain RAM

Job description

Position Summary:

The Quality Assurance Operations Shop Floor Associate is part of the Quality Assurance Operations team at Civica's Petersburg, Virginia manufacturing facility. The Petersburg site serves as Civica's new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. This role will function to ensure ongoing compliance with cGMP requirements on the manufacturing floor.

Key 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, as well as communicate and resolve discrepancies with manufacturing operators and/or 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.

Essential Duties and Responsibilities:

• Working across functions to ensure operational compliance in all aspects of product manufacturing.
• Enforcing adherence to all Civica standard operating procedures (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.

Basic Qualifications and Capabilities:

• Bachelor's degree or above in a scientific discipline.
• Minimum of 2+ years of experience within a pharmaceutical, biotech, cell therapy, or medical device cGMP-regulated manufacturing environment.
• 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 based on target audience.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Detail-oriented and task-focused with the ability to meet deadlines and support work prioritization.

Physical Demands and Work Environment:

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 occasionally 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 this position requires include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

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