Quality Assurance Associate

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

Job summary

Civica's Petersburg, Virginia manufacturing facility seeks a Quality Assurance Operations Shop Floor Associate to uphold cGMP on the manufacturing floor. The role collaborates with operations to ensure batch records, aseptic practices, and gowning meet procedures and quality standards.

You'll perform on-the-floor reviews, document nonconformances, and support continuous improvement while using systems like Veeva, Deacom, and Blue Mountain RAM.

Qualifications

• Bachelor's degree in a scientific discipline.
• Minimum 2+ years in a pharmaceutical/cGMP-regulated manufacturing environment.
• Experience with sterile pharmaceutical isolator technology, combination products, or medical devices.
• Experience delivering training on cGMP regulations, SOPs, and quality systems.

Responsibilities

• Provide QA oversight on the manufacturing floor regarding procedures, batch records, aseptic technique, gowning, nonconformances, and sampling.
• On-the-floor review of batch records during execution and communication of discrepancies with operators or supervisors.
• Familiarity with electronic management systems such as Veeva, Deacom, and Blue Mountain RAM.
• Facilitate QA oversight on the shop floor through walkthroughs and process observations to ensure cGMP adherence.
• Identify and implement improvements to procedures and processes as part of continuous improvement initiatives.
• Enforce adherence to Civica SOPs and promote a quality and safety mindset.

Skills

Attention to detail

Communication skills

Team collaboration

cGMP knowledge

Education

Bachelors degree in sciences

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.