GMP Process & CAPA Specialist (Aseptic) - Flexible Hours

INCOG BioPharma; Fishers (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

INCOG BioPharma is seeking a Process Specialist to work with operations and the quality systems team. The role focuses on manufacturing deviation investigations, CAPA implementation, and aseptic manufacturing expertise to influence outcomes.

The position requires strong communication, data-driven problem solving, and the ability to lead cross-functional process improvements while ensuring compliance with cGMPs in a fast-paced setting.

Qualifications

• 4 years minimum experience working in a GMP environment.
• Deviation and technical writing experience.
• Batch record and manufacturing report review experience.
• Familiarity with quality/regulatory requirements and cGMPs.
• Excellent written and verbal communication skills.

Responsibilities

• Support authoring, reviewing, and approving SOPs & Work Instructions.
• Directs or conducts studies to ascertain best sequence of operations.
• Review productivity and develop action plans with operations to improve performance.
• Maintain effective communication across departments and with external clients.
• Lead root cause analysis using fishbone, 5 Whys, and statistical tools.

Skills

Process control

Quality engineering

Statistical techniques

Project management

Communication skills

Tools

SCADA

Word

Excel

Visio

JMP

Minitab

Job description

INCOG BioPharma is seeking a Process Specialist to work with operations and the quality systems team. The role focuses on manufacturing deviation investigations, CAPA implementation, and aseptic manufacturing expertise to influence outcomes.

The position requires strong communication, data-driven problem solving, and the ability to lead cross-functional process improvements while ensuring compliance with cGMPs in a fast-paced setting.