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Manufacturing Supervisor
2 months ago
Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States.
Our mission is to improve patient access to affordable medications, and we are committed to doing what is in the best interest of patients.
Job SummaryThe Supervisor Manufacturing Prep and Fill will play a key role in the facility start-up, with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the Civica Petersburg, VA site.
Key Responsibilities- Lead the Prep and Fill Operations team to execute daily and weekly production schedules to meet operations objectives.
- Conduct daily shift meetings to communicate current events and issues and solicit team feedback.
- Monitor team productivity and resolve immediate production needs to facilitate efficiency.
- Manage daily and weekly staffing requirements to account for absent personnel (PTO) to satisfy production needs.
- Monitor the inventory of department supplies and report any quality issues and shortages to prevent production interruptions.
- Conduct training and ensure staff training is documented, current, and follows cGMP requirements.
- Review batch records, cycle reports, and other manufacturing documentation to identify and address any potential quality issues.
- Perform and/or oversee batch accountability calculations and final batch quantity confirmations.
- Provide immediate support in the identification and documentation of deviations and discrepancies.
- Assist in the development and update of manufacturing procedures and training material.
- Support cross-departmental activities, including maintenance, qualification, testing, and investigational activities.
- Assist R&D and MSAT on new product introduction and tech transfer activities to meet commercial demand.
- Initiate and complete manufacturing investigations including root cause analysis and product impact assessment.
- Assist in the revision, and management of manufacturing documents such as Batch Records and SOPs.
- 8 years experience in a GMP manufacturing environment. Prep and Fill operation experience preferred.
- 2 years of supervisory experience in GMP manufacturing.
- Associate's degree, or 8 years of cGMP production experience and knowledge, may be considered.
- Strong writing and documentation skills.
- Strong interpersonal, collaboration, communication, and leadership skills.
- Experience in a process improvement environment, including change management, optimizing process flow and participating in Lean/Six Sigma project teams.
- Self-directed with effective analytical and problem-solving skills.
- Interact with other functions and must be able to take ownership of and follow through on assigned projects.
