cGMP Manufacturing Operations Specialist

Alcami Corporation; Michigan; On-site; USD 90,000 - 120,000; Full time

Job summary

Alcami Corporation seeks a Technical Operations Specialist to support cGMP manufacturing, provide technical oversight, troubleshoot production issues, and ensure Continued Process Verification activities maintain process performance and product quality.

You will work cross-functionally with Technical Services, Operations, Quality, Engineering, and EHS, manage documentation routing, and mentor team members.

Qualifications

• At least 5 years of experience in a pharmaceutical cGMP Manufacturing setting.
• Related bachelor's degree preferred.
• Minimum 1 year of experience in Technical Writing (deviations, SOPs, Batch Records, etc.).
• Demonstrated leadership and training experience.
• Proficiency with Microsoft Office Suite preferred.

Responsibilities

• Support commercial and clinical cGMP manufacturing operations using data analysis to identify areas of improvement and overall manufacturing trends.
• Troubleshoot unexpected manufacturing events and production issues as a process SME, authoring investigations and facilitating the closure of investigations in a timely fashion.
• Ensure robust, reliable, and compliant product manufacturing.
• Prepare, execute, and evaluate Continued Process Verification (CPV) activities.
• Monitor process performance and identify opportunities for improvement.
• Provide ongoing technical support to manufacturing teams.
• Partner with Technical Services, Operations, Quality, Engineering, and EHS Teams to resolve documentation and manufacturing process issues resulting in CAPAs and process deviations.
• Coordinate activities to ensure alignment across manufacturing functions.
• Facilitate communication and issue resolution between departments.
• Track and route documentation through required reviewers and approval channels, ensuring timely completion of document review and information accuracy.
• Create and maintain standard work documents including checklists, MBRs, and MPR templates.
• Author Change Controls to support investigations, process changes, and equipment modifications.
• 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 cGMP processes.

Skills

Data analysis

Troubleshooting

Process improvement

Cross-functional collaboration

Technical writing

Leadership

Documentation management

MS Office

Education

Bachelor's degree in related field

Tools

Microsoft Office Suite

Job description

Alcami Corporation seeks a Technical Operations Specialist to support cGMP manufacturing, provide technical oversight, troubleshoot production issues, and ensure Continued Process Verification activities maintain process performance and product quality.

You will work cross-functionally with Technical Services, Operations, Quality, Engineering, and EHS, manage documentation routing, and mentor team members.