QA Operations Lead - Sterile Fill/Finish

Socket.dev; Petersburg (VA); On-site; USD 120,000 - 150,000; Full time

Job summary

Civica, Inc. in Petersburg, VA is seeking a Quality Assurance Supervisor - Operations to lead quality systems for sterile manufacturing and ensure FDA/DEA regulatory compliance.

The role focuses on building CGMP-ready processes from site initiation through FDA approvals and ongoing product quality across the lifecycle. The position requires 5+ years in pharmaceutical QA/CGMP, with strong project management and leadership, and a commitment to safety and quality on a fast-paced site.

Qualifications

• Bachelor’s degree in a scientific discipline with a minimum of 5+ years of Quality/CGMP experience in the pharmaceutical industry. Experience in sterile injectable manufacturing and packaging operations is required.
• Strong project management, organization, and execution skills with a proven track record of shop floor manufacturing.
• Quality assurance experience across the product development and commercialization lifecycle.
• Participation and leading activities to support regulatory agency inspections required.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills, and share knowledge with others.
• Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.
• Prior experience in a supervisory role highly desired.

Responsibilities

• Establish and maintain the site’s quality systems related to manufacturing operations to enable reliable supply of quality generic medications to patients.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operational activities.
• Responsible for operational compliance aspects of sterile fill-finish manufacturing of products, including aseptic process simulations, terminal sterilization, batch record review, batch disposition, and shop-floor quality.
• Ensure that all aspects of the handling and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and DEA regulatory requirements.
• Establish and maintain Standard Operating Procedures and training consistent with CGMPs for QA shop-floor support.
• Provide leadership, direction, and support to ensure shop floor associates and operators are qualified, achieve a high level of competence, are motivated, and carry out their duties in a safe manner.
• Maintain written procedures and associated records for personnel qualification and training and support the delivery of compliance training sessions.
• Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing.
• Support, review and approve equipment qualifications and product and process transfers, including validation, from development and/or other manufacturing sites.
• Establish and maintain SOPs and training to ensure raw materials, excipients, APIs and components are qualified, and their suppliers are approved in accordance with Civica and GMP requirements.
• Establish and maintain SOPs and training to ensure that all components, raw materials, excipients, drug product containers, closures, in-process materials, packaging material, labeling and drug products are released in accordance with the registered specifications.
• Responsible for Quality shop-floor oversight including real-time batch record review, response to deviations and implementation of corrective actions.
• Support quality processes and systems across the product lifecycle including CAPA, deviations and investigations, label control, laboratory control, product quality complaints, APQR, and management notification.
• Participate in quality risk analysis.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
• Travel is limited but may occasionally be required.

Skills

Quality Assurance

CGMP

Project management

Leadership

Communication

Education

Bachelor’s degree in a scientific discipline

Tools

Documentation systems

Job description

Civica, Inc. in Petersburg, VA is seeking a Quality Assurance Supervisor - Operations to lead quality systems for sterile manufacturing and ensure FDA/DEA regulatory compliance.

The role focuses on building CGMP-ready processes from site initiation through FDA approvals and ongoing product quality across the lifecycle. The position requires 5+ years in pharmaceutical QA/CGMP, with strong project management and leadership, and a commitment to safety and quality on a fast-paced site.