Process Specialist

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 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

Don’t meet all the requirements? Don’t 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.