Manufacturing Manager
4 weeks ago
Civica Rx is seeking a highly skilled Manufacturing Manager to join our team at the Civica Petersburg, VA site. The successful candidate will be responsible for leading the manufacturing team to achieve efficient, cost-effective, safe, and compliant production of quality injectable products.
Key Responsibilities
- Develop and support the Manufacturing team by participating in equipment qualifications, identifying and implementing process improvements through process monitoring, conducting investigations, and impact assessments.
- Lead the manufacturing team to achieve efficient, cost-effective, safe, and compliant production of quality injectable products according to the Civica culture and vision of what is in the best interest of the patient.
- Collaborate with stakeholders to lead day-to-day Manufacturing Nest and Fill responsibilities on the 2nd shift, overseeing and running all equipment, supporting new product introductions, equipment qualifications, change management, investigations, training, and development.
- Develop and create standard operating procedures, specifications, and other forms of governing documents to delineate manufacturing process requirements according to qualification, compliance, and business requirements.
- Ensure that the Manufacturing organization operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
Requirements
- Bachelor's degree with 8+ years of demonstrated ability in a cGMP production environment. An Associate degree and 10 years of cGMP production experience may be considered.
- Experience in a sterile fill-finish facility. 3+ years' supervisory experience in a GMP manufacturing environment.
- Strong writing and documentation skills.
- Experience in a process improvement environment, including change management, optimizing process flow and participating in Lean/Six Sigma project teams.
About Civica Rx
Civica Rx is a non-profit generic drug company dedicated to reducing chronic generic drug shortages and related high prices in the United States. We are committed to putting the needs of patients first and working with healthcare stakeholders to improve access to affordable medications.
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