Quality Assurance Operations Supervisor 1st​/2nd shift

Job Overview

The Quality Assurance Supervisor-Operations will join the Civica, Inc. (“Civica”) organization and its newly forming team at the Petersburg, Virginia site, bringing their knowledge and experience in service to patients and pursuing excellence in quality and compliance. The Petersburg site serves as Civica’s new fill-finish facility dedicated to manufacturing and supplying essential generic sterile injectable medications.

The role is essential to ensure the Petersburg site’s manufacturing and operations activities comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines.

Responsibilities of the position include establishing and maintaining quality and compliance processes associated with sterile manufacturing and operations from the onset of building and qualifying the facility, leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

Responsibilities also include, but are not limited to, shop floor oversight and the generation, review, and/or approval of policies, procedures, reports, batch records, and other records necessary to support the design, implementation, and maintenance of manufacturing processes that meet or exceed FDA requirements.

• Working across functions, 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 but not limited to 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 Drug Enforcement Administration (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 Standard Operating Procedures, 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 Standard Operating Procedures 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, but not limited to, change control, CAPA, deviations and…