Aseptic Manufacturing Specialist — cGMP & Process Improvement

Alcami Corporation; North Charleston (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

Alcami Corporation in Charleston, SC is seeking a Manufacturing Specialist - Aseptic to support cGMP manufacturing and troubleshoot events, preparing, conducting, and evaluating continued process verification activities. This role collaborates with Formulation Development, Manufacturing, QA and Regulatory, EHS and Engineering to ensure robust sterile drug product production.

The ideal candidate will have a related bachelor's degree or equivalent experience, strong leadership, data analysis, and

Qualifications

• Bachelor's degree preferred with 2+ years in sterile injectable manufacture.
• Alternative: HS diploma with 8+ years in sterile injectable production.
• Minimum 1 year experience in technical writing (deviations, SOPs, batch records).
• Demonstrated leadership and training experience.

Responsibilities

• Perform data analysis and trend manufacturing processes to identify improvements.
• Review and approve batch records and perform investigations.
• Author Change Controls to support investigations, process changes and equipment modifications.
• Author investigations and facilitate the closure of investigations on time.
• Seeks opportunities to improve process performance within defined ranges.
• Troubleshoots unexpected events during cGMP manufacturing and documents deviations and CAPAs.

Skills

Leadership

Data analysis

Technical writing

GMP knowledge

Process troubleshooting

Education

Bachelor's degree in a related field

High school diploma with 8+ years experience

Tools

Microsoft Office

Data analysis tools

Job description

Alcami Corporation in Charleston, SC is seeking a Manufacturing Specialist - Aseptic to support cGMP manufacturing and troubleshoot events, preparing, conducting, and evaluating continued process verification activities. This role collaborates with Formulation Development, Manufacturing, QA and Regulatory, EHS and Engineering to ensure robust sterile drug product production.

The ideal candidate will have a related bachelor's degree or equivalent experience, strong leadership, data analysis, and