Process Specialist

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 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

Dont meet all the requirements? Dont sweat! We're always looking for an excuse to discuss your next opportunity. You might just surprise yourself...

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.