GMP Process & Deviation Specialist

Lead Candidate; Fishers (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Paid time off

11 paid holidays

401(k) match

Health plan options

FSA/HSA options

Onsite wellness facility

Team engagement events

Job summary

INCOG BioPharma Services is seeking an experienced Process Specialist to support SOPs and Work Instructions, collaborate with Manufacturing and QA, and help investigate deviations in MFG activities.

The role requires strong communication, familiarity with cGMPs, 4 years GMP experience, 2 years deviation/technical writing, and ability to work autonomously in a fast-paced environment; on-site in Fishers, IN.

Qualifications

• 4 years minimum experience working in a GMP environment.
• 2 years minimum Deviation and technical writing experience.
• Familiarity with relevant quality and regulatory requirements and trends and cGMP's.
• Strong communication skills and the ability to build relationships across all levels of the organization.

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.
• Work autonomously managing multiple projects and within a team in a fast-paced, deadline-oriented environment.

Skills

GMP experience

Deviation handling

Technical writing

Regulatory knowledge

Communication skills

Job description

INCOG BioPharma Services is seeking an experienced Process Specialist to support SOPs and Work Instructions, collaborate with Manufacturing and QA, and help investigate deviations in MFG activities.

The role requires strong communication, familiarity with cGMPs, 4 years GMP experience, 2 years deviation/technical writing, and ability to work autonomously in a fast-paced environment; on-site in Fishers, IN.