Quality Assurance Operations Supervisor
2 days ago
Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that quality generic medications are accessible and affordable to everyone.
Job DescriptionThe QA Operations Specialist II will join our team at the Petersburg, Virginia site, bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as our new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
Responsibilities- Establish and maintain the site's quality systems related to insulin, biologics, and biosimilar manufacturing operations to enable reliable supply of quality medications to patients.
- Promote a quality mindset and quality excellence approach to all activities.
- Responsible for operational compliance aspects of sterile fill finish manufacturing of products, including aseptic process simulations, terminal sterilization, batch record review, 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 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 change control, CAPA, deviations, and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.
- Participate in quality risk analysis.
- Proactively identify and work collaboratively to resolve problems, taking risk-based and compliant approaches to solutions.
- Bachelor's degree in a scientific discipline with a minimum of 8 years 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.
- Supervisory experience.
- Quality assurance experience across the product development and commercialization lifecycle, including participation and leading activities to support regulatory agency inspections.
- 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.
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