GMP Process Specialist — Deviations & SOP Expert

Lead Candidate Ltd; Fishers (IN); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

PTO and holidays

401(k) plan with company match

Health & wellness plans

FSA/HSA options

Onsite wellness facility

Team engagement activities

Job summary

INCOG BioPharma Services seeks an experienced Process Specialist to work with the operations team and QA systems to investigate deviations related to manufacturing activities. You will author, review, and approve SOPs and Work Instructions, and maintain strong communication with other departments to improve efficiency.

Ideal candidates have 4+ years in GMP, familiarity with cGMPs, and 2 years of deviation handling and technical writing experience, with the ability to manage multiple projects in

Qualifications

• Familiarity with regulatory requirements and cGMPs.
• Strong communication skills and ability to build relationships across organization.
• 4 years minimum experience in a GMP environment.
• 2 years minimum deviation and technical writing experience.

Responsibilities

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

Skills

GMP compliance

cGMP knowledge

Deviation handling

Technical writing

Cross-functional communication

Job description

INCOG BioPharma Services seeks an experienced Process Specialist to work with the operations team and QA systems to investigate deviations related to manufacturing activities. You will author, review, and approve SOPs and Work Instructions, and maintain strong communication with other departments to improve efficiency.

Ideal candidates have 4+ years in GMP, familiarity with cGMPs, and 2 years of deviation handling and technical writing experience, with the ability to manage multiple projects in