Senior QA Operations Floor Lead — Sterile Manufacturing

Civica

Petersburg (VA)

On-site

USD 90,000 - 120,000

Full time

14 days+
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Job summary

Civica's Petersburg, Virginia facility seeks a senior Quality Assurance Operations Shop Floor Specialist to oversee manufacturing operations, ensuring accuracy, compliance, efficiency and safety. As the senior QA Ops member, you will lead cross-functional teams, approve procedures, provide training, monitor deviations, and maintain quality systems across site operations.

The role requires a Bachelor's in a scientific field and 4+ years in regulated pharma/biotech manufacturing with GMP

Qualifications

  • Bachelor's degree in a scientific discipline.
  • 4+ years of experience in pharmaceutical/biotech/cGMP manufacturing.
  • Experience with sterile isolator technology, 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 able to learn new software.
  • Strong data interpretation and problem-solving skills.
  • Excellent written and verbal communication; ability to present technical data.

Responsibilities

  • Identify departures from approved procedures and respond to complex issues independently.
  • Develop, review and/or approve temporary/non-routine procedures for event response.
  • Observe manufacturing operations for deviations in clean room, aseptic techniques, and gowning.
  • Coordinate area walkthroughs; drive remediations and implementation alignment.
  • Own actions for departmental programs and propose improvements.

Skills

QA leadership
GMP knowledge
SOPs training
Data interpretation
Cross-functional collaboration
Training delivery
Documentation review
Communication skills

Education

Bachelor's degree in a scientific discipline

Tools

MS Office
Quality management systems

Job description

Civica's Petersburg, Virginia facility seeks a senior Quality Assurance Operations Shop Floor Specialist to oversee manufacturing operations, ensuring accuracy, compliance, efficiency and safety. As the senior QA Ops member, you will lead cross-functional teams, approve procedures, provide training, monitor deviations, and maintain quality systems across site operations.

The role requires a Bachelor's in a scientific field and 4+ years in regulated pharma/biotech manufacturing with GMP

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