QA Supervisor - Operations - 2nd shift (368)

About the role

The Quality Assurance Supervisor – Operations will join Civica, Inc.’s newly forming team at the Petersburg, Virginia site, a new fill‑finish facility dedicated to manufacturing and supplying essential generic sterile injectable medications. The role ensures that manufacturing and operations activities comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and supports the development and reliable supply of quality medicines.

Schedule

Sunday – Wednesday, 1:00 PM – 11:30 PM.

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 safety‑mindset across all activities.
• Ensure operational compliance for sterile fill‑finish manufacturing, including aseptic process simulations, terminal sterilization, batch record review, batch disposition, and shop‑floor quality.
• Guarantee that handling and manufacturing of pharmaceutical products comply with Civica, FDA, and DEA regulatory requirements.
• Develop and maintain Standard Operating Procedures (SOPs) and training consistent with CGMP for QA shop‑floor support.
• Provide leadership, direction, and support to shop‑floor associates and operators, ensuring they are qualified, competent, motivated, and work safely.
• Maintain written procedures and records for personnel qualification and training; deliver compliance training sessions.
• Stay current with FDA and Civica requirements to keep pace with evolving manufacturing standards.
• Support, review, and approve equipment qualifications and product/process transfers, including validation, from development or other manufacturing sites.
• Establish SOPs and training to qualify raw materials, excipients, APIs, components, and to approve suppliers in accordance with Civica and GMP requirements.
• Ensure release of components, raw materials, drug‑product containers, closures, in‑process materials, packaging, labeling, and drug products according to registered specifications.
• Oversee shop‑floor quality, including real‑time batch record review, deviation response, and implementation of corrective actions.
• Support quality processes across the product lifecycle: change control, CAPA, deviations, investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
• Participate in quality risk analysis and proactively resolve problems using risk‑based, compliant approaches.
• Travel is limited but may occasionally be required.

Qualifications

• Bachelor’s degree in a scientific discipline.
• Minimum 5 + years of Quality/CGMP experience in the pharmaceutical industry.
• Required experience in sterile injectable manufacturing and packaging operations.
• Strong project management, organization, and execution skills with a proven track record on the shop floor.
• Quality assurance experience across the product development and commercialization lifecycle.
• Experience leading activities to support regulatory agency inspections.
• Excellent interpersonal and written communication skills; proficient with various software/electronic applications.
• Self‑motivated, flexible, and able to work in a small, fast‑paced, dynamic environment.
• Ability to work autonomously within established guidelines, procedures, and practices.
• Commitment to delivering high‑quality results, collaborating to overcome challenges, and focusing on what matters.
• Continuous learner who seeks opportunities to build skills and share knowledge.
• Desired: Experience with Drug Enforcement Agency (DEA) requirements for handling and distribution of controlled substances.
• Desired: Prior supervisory experience.

Physical Demands and Work Environment

The physical demands described are representative of those required to successfully perform the essential functions of this position. While performing essential duties, the employee is regularly required to speak or hear, frequently uses hands or fingers to handle objects, tools, or controls, and is occasionally required to stand, walk, sit, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually low to moderate. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.