GMP Process Improvement Specialist

INCOG BioPharma Services; Fishers (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

INCOG BioPharma Services is seeking a Process Specialist to work with the operations team, identify process improvements, and address procedural gaps, collaborating with quality systems on deviations and CAPA implementation.

The role requires strong communication, self-management, and the ability to influence outcomes without direct authority, with experience in GMP environments and cross-functional teamwork.

Qualifications

• 4 years minimum experience in a GMP environment.

Responsibilities

• Identify and develop best practices/SOPs to improve efficiency.
• Directs or conducts studies to ascertain the best sequence of operations or workflow.
• Participate in process FMEAs to understand process and product risks.
• Maintain effective communication with other departments and employees.
• Support authoring, reviewing and approving SOPs and Work Instructions.
• Participate in cross-functional teams to advance project activities.

Skills

Process improvement

SOP development

Time studies

Data analysis

Project management

Communication

Cross-functional collaboration

Attention to detail

Self-management

Change management

Influence without authority

Education

Bachelor's degree in Engineering or related field

Tools

SCADA

eDMS

BMS

CMMS

LIMS

Excel

JMP

Minitab

Visio

Job description

INCOG BioPharma Services is seeking a Process Specialist to work with the operations team, identify process improvements, and address procedural gaps, collaborating with quality systems on deviations and CAPA implementation.

The role requires strong communication, self-management, and the ability to influence outcomes without direct authority, with experience in GMP environments and cross-functional teamwork.