Senior QA Shop Floor Lead: GMP & Compliance

BioSpace; Petersburg (VA); On-site; USD 110,000 - 140,000; Full time

Job summary

Civica’s Petersburg, Virginia manufacturing facility seeks a senior Quality Assurance Operations Shop Floor Specialist to oversee manufacturing operations on the floor. You will act as the senior QA representative, ensuring compliance, accuracy, efficiency, and safety while partnering with cross-functional teams to drive continuous improvement.

The role requires deep cGMP knowledge, experience with sterile systems, and the ability to train floor personnel, review procedures, and lead site-wide

Qualifications

• Bachelor's degree in a scientific field is required.
• Minimum 4+ years in pharma/biotech or related cGMP manufacturing environment.
• Experience with sterile isolator technology, combination products, or medical devices.
• Experience delivering training on cGMP, SOPs, and quality systems.
• Ability to research, interpret, and apply internal SOPs, policies, and regulatory guidelines.
• Excellent written and verbal communication; capable of presenting data clearly.

Responsibilities

• Identify departures from approved procedures and respond to complex issues independently.
• Develop, review, and approve procedures for event response.
• Observe manufacturing operations for clean room, aseptic techniques, and gowning.
• Coordinate area walkthroughs and drive remediation plans with cross-functional teams.
• Own actions for departmental programs and propose improvements.
• Communicate and resolve discrepancies; escalate as required.
• Author and review procedural documents.
• Provide guidance and training for floor personnel.
• Assess discrepancies for quality system entry and initiate deviations.
• May serve as QA SME for site-wide assessments.
• Lead meetings and represent QA in cross-functional discussions.
• Share data and knowledge; maintain strong QA culture relationships.
• May prioritize and assign tasks for the QA Shop Floor team.
• Observe operations to identify risks and drive improvements.
• Familiar with GMP management systems for quality documentation, supplies and equipment.

Skills

cGMP knowledge

SOPs understanding

Quality systems

Training others

Data interpretation

Verbal & written communication

Cross-functional collaboration

Fast-paced team leadership

Decision making

Education

Bachelor's degree in a scientific discipline

Tools

MS Office

Job description

Civica’s Petersburg, Virginia manufacturing facility seeks a senior Quality Assurance Operations Shop Floor Specialist to oversee manufacturing operations on the floor. You will act as the senior QA representative, ensuring compliance, accuracy, efficiency, and safety while partnering with cross-functional teams to drive continuous improvement.

The role requires deep cGMP knowledge, experience with sterile systems, and the ability to train floor personnel, review procedures, and lead site-wide