Quality Systems Specialist
: Job Details :

Quality Systems Specialist

INCOG Biopharma Services in Indianapolis, IN is hiring a Quality Systems Specialist. INCOG is seeking a highly motivated individual who will be instrumental in engaging the site in performing investigations, change plan development and change action and CAPA fulfillment, and leading the assessments for risk against validated systems and process states, and impact to product quality and safety.

The main aspect of this role will rely on the Specialist's strong familiarity with industry standard Deviation/investigation, root cause assessment, risk assessment, change management, and CAPA processes. They will work directly with Project Management in acting as Quality liaison with Client Quality Units. The individual will coordinate site SMEs in Client engagement to ensure Quality Event timelines are met in the furtherance of product quality and release assurances.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, they are more than just a CDMO. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At their core, that is who they are—a dedicated team that believes they can always be better.

Join the team at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients, for yourself, and for INCOG's clients.

Job Functions:

• Perform robust investigations to determine root causes for deviating conditions or nonconforming materials or products across technical departments, in alignment with Subject Matter Experts in those areas.
• Support internal customers on the design and documentation of sitewide change controls, deviations and CAPAs and provide assessment of their impacts and risks.
• Support internal customers with, and provide troubleshooting for, the electronic Quality Management System.
• Maintain metrics for the Quality Management processes in support of assessing process health and trends to determine needs for process improvements or deviation/nonconforming product prevention.
• Lead discussions with auditors and inspectors on the planning, enacting, assessments, and results of completed or in-process Quality Events.
• Provide planning and assessment support in Deviation/investigation, Change Control, or CAPA authoring and review decision-making.
• Provide notification, support, and reporting out of Quality Event details and timelines to Clients, and coordination with internal SMEs toward timeline requirements.

Candidate Requirements:

• Bachelor's degree in a scientific field
• At least 5 years' experience in a regulated industry.
• 3+ years' experience performance and management of Quality Systems processes, along with experience a sa user in an eQMS.
• 3+ years' experience with internal customer service in support of Deviations, Change Controls and/or CAPAs.

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.