Aseptic Manufacturing Specialist: Lead & Analyze

Alcami Corporation; South Carolina; On-site; USD 65,000 - 85,000; Full time

Job summary

Alcami Corporation is seeking a Manufacturing Specialist - Aseptic to support cGMP manufacturing, troubleshooting, and continuous verification activities. You will collaborate with Formulation Development, Manufacturing, QA, Regulatory, EHS and Engineering to ensure robust production of sterile drug products and develop leadership in training others.

The role emphasizes on-site execution, data analysis, and technical writing experience to document deviations, SOPs, and batch records, with a

Qualifications

• Bachelor's degree preferred with 2+ years related experience in sterile injectable products in a regulated environment.
• Or applicants with high school or equivalent certification with 8+ years related experience in the manufacture of sterile injectable products in a regulated environment.
• Must have at least 1 year of experience in technical writing (deviations, SOPs, batch records, etc.).

Responsibilities

• Perform data analysis, including tracking and trending of manufacturing processes to identify areas of improvement.
• Measure and evaluate unit operation durations to implement optimal scheduling to meet facility and client requirements.
• Author Change Controls to support investigations, process changes and equipment modifications.
• Author investigations and facilitate the closure of investigations on time.
• Review and approve new batch records as well as perform review of executed batch records.
• Provides training to manufacturing staff on operating procedures, batch records and GMP process rationale.
• Provides technical, on the floor support of commercial, clinical, and validated processes.
• Supports clients/stakeholders as a subject matter expert of commercial, clinical, and generic products.
• Evaluates product impact of process excursions outside proven acceptable ranges.
• Seeks opportunities to improve process performance within process ranges defined by large-scale equipment capabilities.
• Troubleshoots unexpected events during cGMP manufacturing, assists other departments in investigating and documenting process deviations and CAPAs.

Skills

Leadership

Training

Technical writing

Data analysis

Communication

Education

Bachelor's degree preferred

High school or equivalent with 8+ years experience

Tools

Microsoft Office

Job description

Alcami Corporation is seeking a Manufacturing Specialist - Aseptic to support cGMP manufacturing, troubleshooting, and continuous verification activities. You will collaborate with Formulation Development, Manufacturing, QA, Regulatory, EHS and Engineering to ensure robust production of sterile drug products and develop leadership in training others.

The role emphasizes on-site execution, data analysis, and technical writing experience to document deviations, SOPs, and batch records, with a