Current jobs related to MSAT Specialist - Washington, Washington, D.C. - Civica Rx

Civica Rx is a leading social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to provide essential generic sterile injectable medications to patients in need.

We are a collaborative organization, working closely with health systems, philanthropies, and industry leaders to achieve our goals. Our team is comprised of experienced healthcare and pharmaceutical industry professionals who are passionate about making a difference in the lives of patients.

We are seeking a highly skilled MSAT Specialist to join our team at our Petersburg, Virginia site. As an MSAT Specialist, you will play a critical role in ensuring the quality and compliance of our manufacturing processes.

• Conduct technical investigations and process support activities to identify and resolve issues related to our manufacturing processes.
• Collaborate with cross-functional teams, including Manufacturing, Quality, Validation, and Engineering, to perform risk assessments and impact assessments.
• Write and review technical documents, including SOPs, protocols, and reports, to ensure compliance with regulatory requirements.
• Provide support to equipment, facilities, and utilities qualification, as needed.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.

• Bachelor's degree in a scientific discipline with 7+ years of cGMP experience in the sterile pharmaceutical industry.
• Understanding of Quality Management Systems at pharma manufacturing sites.
• Strong interpersonal and written communication skills.
• Excellent problem-solving and troubleshooting skills.
• Strong project management, organization, and execution skills to manage multiple projects and priorities.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
• Committed to delivering high-quality results.
• Ability to work effectively in a team-oriented environment.

• Technical expertise in sterile pharmaceutical industry with experience in isolator technology and knowledge of sterilization equipment.
• Basic understanding of microbiological aspects of the process and products.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions.

• Capable of working in office settings in front of computer/laptop with long sittings.
• Occasional entry to manufacturing and clean rooms is required.
• Travel (up to 10%) may be required.