Aseptic Process Improvement Specialist

INCOG BioPharma Services; Fishers (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

INCOG BioPharma Services seeks a Process Specialist to work with operations and quality systems, providing feedback for deviation investigations and CAPA implementation. The role requires aseptic manufacturing knowledge and cross-functional project leadership to improve process efficiency while upholding quality.

You will help author and review SOPs, lead root-cause analyses, and maintain data integrity in batch records.

Qualifications

• Knowledge of process control, quality engineering and statistics.
• Familiarity with quality/regulatory requirements and cGMPs.
• Strong communication across levels and teams.
• 4+ years in a GMP environment.
• Batch record and manufacturing report review experience.
• Deviation and technical writing experience.
• Client and regulatory audit experience.
• Excellent written and verbal communication skills.
• Experience with SCADA, LIMS and data analysis tools.

Responsibilities

• Support SOPs, work instructions, and efficiency improvements.
• Lead studies to optimize operation sequences and workflows.
• Review productivity and partner with operations on actions.
• Act as SME for aseptic processes and related quality controls.
• Lead root cause analysis using 5 Whys, fishbone diagrams, statistics.
• Collaborate across departments and with external clients.
• Manage multiple projects with deadlines in a fast-paced environment.
• Support FMEAs to assess process and product risks.
• Ensure data integrity in batch records using systems like SCADA/LIMS.

Tools

SCADA

LIMS

JMP

Minitab

Visio

Excel

Word

Job description

INCOG BioPharma Services seeks a Process Specialist to work with operations and quality systems, providing feedback for deviation investigations and CAPA implementation. The role requires aseptic manufacturing knowledge and cross-functional project leadership to improve process efficiency while upholding quality.

You will help author and review SOPs, lead root-cause analyses, and maintain data integrity in batch records.