Senior QA Operations Specialist – Cleanroom & Compliance

Civica Rx; Petersburg (VA); On-site; USD 90,000 - 130,000; Full time

Job summary

Civica Rx in Petersburg, Virginia, seeks a senior Quality Assurance Operations Shop Floor Specialist to lead the QA Shop Floor team on the manufacturing floor of Civica’s new fill-finish facility. This role ensures compliance, efficiency, and safety while guiding cross-functional collaborations.

You will review procedures, train floor staff, oversee deviations and CAPA processes, and drive improvements in GMP-aligned operations.

Qualifications

• Bachelor’s degree or above in a scientific discipline.
• 4+ years in pharmaceutical, biotech, or cGMP manufacturing.
• Experience with sterile isolator tech, combination products, or medical devices.
• Experience delivering training on cGMP, SOPs, and quality systems.
• Ability to interpret internal SOPs, policies, and regulatory guidelines.
• Proficient with MS Office and new software tools.

Responsibilities

• Identify departures from approved procedures and respond to complex issues independently.
• Develop, review and approve temporary/non-routine procedures for events.
• Observe operations for clean room, aseptic techniques, and gowning adherence.
• Lead area walkthroughs, coordinate remediations, and align implementation plans.
• Own actions for departmental programs and propose improvements.
• Communicate and resolve discrepancies; escalate when needed.
• Author and review procedural documents.
• Provide guidance and training for floor personnel.
• Assess discrepancies for quality system entry and initiate deviations.
• Serve as QA SME for site-wide assessments as needed.
• Lead meetings and represent QA in cross-functional forums.
• Share data and knowledge with partnering teams and build QA culture.

Skills

GMP knowledge

SOP experience

CAPA management

Quality systems

Data interpretation

Training delivery

Documentation skills

Strong communication

Team leadership

Education

Science degree

Tools

MS Office

Job description

Civica Rx in Petersburg, Virginia, seeks a senior Quality Assurance Operations Shop Floor Specialist to lead the QA Shop Floor team on the manufacturing floor of Civica’s new fill-finish facility. This role ensures compliance, efficiency, and safety while guiding cross-functional collaborations.

You will review procedures, train floor staff, oversee deviations and CAPA processes, and drive improvements in GMP-aligned operations.