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.
We are a team of experienced healthcare and pharmaceutical industry leaders, working together to make a difference in the lives of patients. Our organization is led by a strong commitment to doing what is in the best interest of patients.
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.
The role is essential to assure the Petersburg site's manufacturing and operations activities comply with applicable regulatory standards and expectations for the development and reliable supply of quality medicines.
Responsibilities include:
- Establishing and maintaining the site's quality systems related to insulin, biologics, and biosimilar manufacturing operations.
- Promoting a quality mindset and quality excellence approach to all activities.
- Ensuring operational compliance aspects of sterile fill finish manufacturing of products.
- Maintaining written procedures and associated records for personnel qualification and training.
- Supporting quality processes and systems across the product lifecycle.
Basic Qualifications and Capabilities:
- Bachelor's degree in a scientific discipline with a minimum of 8 years Quality/CGMP experience in the pharmaceutical industry.
- 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.
Preferred Qualifications:
- Technical expertise in sterile pharmaceutical isolator technology, combination product, and medical devices.
- Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances.
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