Process Specialist

Lead Candidate; 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 is seeking an experienced and detail-oriented Process Specialist. They will work directly with the operations team and work closely with Manufacturing and QA systems to investigate deviations related to MFG activities.

WHAT?

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

YOU!

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

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.