QA Supervisor - Operations - 2nd shift (368)

The Quality Assurance Supervisor – Operations will join Civica, Inc. and its newly forming team at the Petersburg, Virginia site, a new fill‑finish facility dedicated to manufacturing and supplying essential generic sterile injectable medications.

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 quality‑excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operational activities.
• Ensure operational compliance of sterile fill‑finish manufacturing, including aseptic process simulations, terminal sterilization, batch record review, batch disposition, and shop‑floor quality.
• Ensure all handling and manufacturing of pharmaceutical products comply with Civica, FDA, and DEA regulatory requirements.
• Establish and maintain Standard Operating Procedures (SOPs) and training consistent with CGMPs for QA shop‑floor support.
• Provide leadership, direction, and support to qualify, motivate, and ensure safe performance of shop‑floor associates and operators.
• Maintain written procedures and records for personnel qualification and training; support delivery of compliance training sessions.
• Stay current with FDA and Civica requirements to keep pace with evolving manufacturing regulations.
• Support, review, and approve equipment qualifications and product/process transfers, including validation, from development or other manufacturing sites.
• Establish and maintain SOPs and training to qualify raw materials, excipients, APIs, components, and approve suppliers in accordance with Civica and GMP requirements.
• Establish and maintain SOPs and training to ensure all components, raw materials, drug product containers, closures, in‑process materials, packaging material, labeling, and drug products are released according to registered specifications.
• Oversee quality on the shop floor, including real‑time batch record review, response to deviations, and implementation of corrective actions.
• Support quality processes across the product lifecycle, including 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.
• Proactively identify and collaboratively resolve problems using risk‑based, compliant approaches.
• Travel is limited but may occasionally be required.

Basic Qualifications and Capabilities

• Bachelor’s degree in a scientific discipline.
• Minimum of 5 + years of Quality/CGMP experience in the pharmaceutical industry.
• Experience in sterile injectable manufacturing and packaging operations (required).
• 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 participating in and leading activities to support regulatory agency inspections.
• Excellent interpersonal and written communication skills; proficiency with various software/electronic applications.
• Self‑motivated, flexible, and able to thrive 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 priorities.
• Continuous learning mindset, seeking opportunities to build skills and share knowledge.
• Experience with Drug Enforcement Agency (DEA) requirements for handling and distribution of controlled substances (desired).
• Prior supervisory experience (highly desired).

Physical Demands and Work Environment

The role requires regular speaking and hearing, frequent use of hands or fingers to handle objects, tools, or controls, and occasional standing, walking, sitting, and reaching with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. The noise level is usually low to moderate. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Schedule

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