Process Specialist - GMP Deviations & SOPs (Manufacturing)

Lead Candidate Ltd; Fishers (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid time off

11 holidays

401(k) match

Health insurance plans

FSA/HSA options

Onsite wellness facility

Team engagement events

Job summary

INCOG BioPharma Services seeks an experienced Process Specialist to support SOP and Work Instruction activities and collaborate with manufacturing, QA, and operations teams in a fast-paced GMP setting.

The role emphasizes deviation investigation, technical writing, and strong communication to ensure compliance and continuous improvement across departments, with onsite collaboration at the Fishers, Indiana site.

Qualifications

• 4+ years of experience in a GMP environment.
• 2 years minimum deviation and technical writing experience.
• Familiarity with cGMPs and regulatory trends.

Responsibilities

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

Skills

GMP experience

Deviation handling

Technical writing

Communication skills

Cross-functional collaboration

Tools

SOP development

Work Instructions

Job description

INCOG BioPharma Services seeks an experienced Process Specialist to support SOP and Work Instruction activities and collaborate with manufacturing, QA, and operations teams in a fast-paced GMP setting.

The role emphasizes deviation investigation, technical writing, and strong communication to ensure compliance and continuous improvement across departments, with onsite collaboration at the Fishers, Indiana site.