Quality Systems Specialist

Quality Systems Specialist

Who?

Does Quality Systems Specialist sound like your next job title?

This exciting opportunity is offered by INCOG BioPharma Services, who is seeking a highly motivated Quality Systems Specialist to join at it's state-of-art CDMO during an exciting time of growth. INCOG is offering the opportunity to contribute towards a better path to market for life-saving drugs. Having recently been voted as one of the Best Places To Work in Indiana for the second year in a row, INCOG is the perfect place to continue building your career.

What?

This role involves close collaboration with the Sr. Manager of QA, and will provide support in the essential functioning of the electronic Quality Management Systems (QMS) across departments.

Main aspects of the role include:

Plan, document, assess, and review/evaluate investigations: deviations, change controls, CAPAs (etc)

Generate QMS metrics, dashboards, and reports to determine needs for process improvements/ NC product prevention

Act as a Quality liaison with Client Quality Units, coordinate the site SMEs in client engagement, ensuring timelines are met, and lead discussions with auditors and inspectors regarding quality events

You!

The ideal candidate will have a Bachelor’s degree in a related scientific field (or appropriate industry experience), as well as a minimum of 5 years experience within a regulated industry. The individual should be confident in performing and managing quality systems and their associated processes and investigations.

Curious? Send us your resume at or you can find more information on our website.

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.