QA Operations Supervisor - Sterile Fill-Finish

BioSpace

Petersburg (VA)

On-site

USD 110,000 - 150,000

Full time

10 days ago

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Job summary

The Quality Assurance Supervisor-Operations will join Civica, Inc. at the Petersburg, Virginia site, leading QA activities for sterile fill-finish manufacturing and supporting FDA/CGMP compliance efforts.

You will build and maintain quality systems, review batch records, and drive a culture of safety and quality across operations. Responsibilities include coordinating SOP development, training, deviations, CAPA, and ongoing regulatory readiness, while ensuring all materials and processes meet

Qualifications

  • Requires a bachelor’s degree in a scientific discipline and 5+ years of Quality/CGMP experience in pharma.
  • Experience in sterile injectable manufacturing and packaging operations is required.
  • Regulatory inspections experience is expected and essential.

Responsibilities

  • Establish and maintain the site’s quality systems related to manufacturing operations to enable reliable supply of quality generic medications.
  • Promote a quality mindset and a safety-focused, compliant work environment.
  • Oversee QA shop-floor activities: batch review, disposition, and deviations.
  • Develop and maintain SOPs and training aligned with CGMPs.
  • Lead qualification and training for personnel and support regulatory inspections.

Skills

Project management
Quality/CGMP
Sterile injectable manufacturing
Regulatory inspections
Interpersonal communication
Autonomy
Learning mindset
DEA requirements
Supervisory experience

Education

Bachelor's degree in a scientific discipline

Tools

QA software

Job description

The Quality Assurance Supervisor-Operations will join Civica, Inc. at the Petersburg, Virginia site, leading QA activities for sterile fill-finish manufacturing and supporting FDA/CGMP compliance efforts.

You will build and maintain quality systems, review batch records, and drive a culture of safety and quality across operations. Responsibilities include coordinating SOP development, training, deviations, CAPA, and ongoing regulatory readiness, while ensuring all materials and processes meet

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