Production Supervisor - 2nd Shift
Indivior
5 hours ago
On-site
Raleigh, NC
Operations
Production Supervisor - 2nd Shift
Responsibilities:
- Oversee prep, compounding filling, and inspection areas for safety, quality, and performance in aseptic and non-aseptic environments.
- Ensure operational areas are in cGMP compliance; establish systems supporting continuous improvement of procedures to heighten quality.
- Ensure timely and accurate documentation and closeout of batch records.
- Manage day-to-day activities of the operational area.
- Develop and review SOPs for Prep, Compounding, and Filling.
- Drive continued improvement; trend KPIs and take appropriate actions.
- People development and management.
- Lead cross-functional teams to solve urgent production issues and implement improvements.
- Investigate pharmaceutical operations and facility nonconformances; perform root cause analysis; determine improvements to manufacturing processes/SOPs/supply chain practices.
- Review technical/supporting documentation (batch/ancillary docs, test results/CoAs, specifications, training records, SOPs, calibration records, packaging/validation protocols).
- Assist with deviation/CAPA investigations and help finalize investigations if needed.
- Serve as SME during internal/external audits; lead presentations.
- Lead Tier 1 meeting and participate in Tier 2 meeting; build a self-sufficient team; cover peers/manager as needed.
Qualifications:
- Demonstrated leadership and supervisory skills.
- Minimum 5 years’ experience in a regulated industry.
- Minimum 3 years related supervisory experience preferred.
- Experience in cGMP manufacturing or clean room production environment preferred.
- Pre-filled syringe experience preferred.
Skills:
- Analytical reasoning and root cause analysis.
- Strong math/calculating skills; computer skills.
- Ability to read/understand/implement technical writing and instructions; problem-solving in a fast-paced environment.
- Get certified on all operational area curriculums (to understand process, improve it, and cover breaks/vacancies).
Responsibilities:
- Oversee prep, compounding filling, and inspection areas for safety, quality, and performance in aseptic and non-aseptic environments.
- Ensure operational areas are in cGMP compliance; establish systems supporting continuous improvement of procedures to heighten quality.
- Ensure timely and accurate documentation and closeout of batch records.
- Manage day-to-day activities of the operational area.
- Develop and review SOPs for Prep, Compounding, and Filling.
- Drive continued improvement; trend KPIs and take appropriate actions.
- People development and management.
- Lead cross-functional teams to solve urgent production issues and implement improvements.
- Investigate pharmaceutical operations and facility nonconformances; perform root cause analysis; determine improvements to manufacturing processes/SOPs/supply chain practices.
- Review technical/supporting documentation (batch/ancillary docs, test results/CoAs, specifications, training records, SOPs, calibration records, packaging/validation protocols).
- Assist with deviation/CAPA investigations and help finalize investigations if needed.
- Serve as SME during internal/external audits; lead presentations.
- Lead Tier 1 meeting and participate in Tier 2 meeting; build a self-sufficient team; cover peers/manager as needed.
Qualifications:
- Demonstrated leadership and supervisory skills.
- Minimum 5 years’ experience in a regulated industry.
- Minimum 3 years related supervisory experience preferred.
- Experience in cGMP manufacturing or clean room production environment preferred.
- Pre-filled syringe experience preferred.
Skills:
- Analytical reasoning and root cause analysis.
- Strong math/calculating skills; computer skills.
- Ability to read/understand/implement technical writing and instructions; problem-solving in a fast-paced environment.
- Get certified on all operational area curriculums (to understand process, improve it, and cover breaks/vacancies).