GMP Process Specialist - SOP & Deviation Expert

Lead Candidate; Fishers (IN); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Paid time off

11 paid holidays

401(k) with match

Health & wellness plans

FSA/HSA options

Onsite wellness facility

Team events

Job summary

INCOG BioPharma Services is seeking an experienced Process Specialist to work with the operations team and QA systems to investigate deviations related to MFG activities. The role focuses on SOPs, work instructions, and maintaining quality/regulatory standards.

You will collaborate across departments, manage multiple projects in a fast-paced environment, and contribute to continuous process improvements. The ideal candidate has GMP experience, strong communication, and technical writing skills,

Qualifications

• Familiarity with quality/regulatory requirements and cGMPs.
• Minimum 4 years GMP experience.
• Minimum 2 years deviation and technical writing experience.

Responsibilities

• Support authoring, reviewing, and approving SOPs & Work Instructions and, if needed, create news to improve efficiency.
• Maintain effective communication with other departments and employees.
• Develop and maintain collaborative relationships with peers and colleagues across the organization, as well as internal and external clients.
• Autonomously manage multiple projects and work within a team in a fast-paced, deadline-oriented environment.

Skills

GMP experience

Deviation handling

Technical writing

SOP authoring

Regulatory knowledge

Communication skills

Job description

INCOG BioPharma Services is seeking an experienced Process Specialist to work with the operations team and QA systems to investigate deviations related to MFG activities. The role focuses on SOPs, work instructions, and maintaining quality/regulatory standards.

You will collaborate across departments, manage multiple projects in a fast-paced environment, and contribute to continuous process improvements. The ideal candidate has GMP experience, strong communication, and technical writing skills,