Senior Specialist, Quality Engineering

QA Specialist

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

This individual supports all QA activities related to Engineering, Validation, and IT in a contract development and manufacturing organization (CDMO) setting. Responsibilities include the review and approval of Change Control records and their deliverables and other GMP controlled documents, resulting in timely QA oversight of equipment, computer system, utility, and facility lifecycle activities including qualification/validation. This individual provides quality oversight of facility, utilities, equipment, and IT infrastructure upgrades and expansions, develops and supports continuous improvement initiatives, and supports client and regulatory audits, as required.

Provide quality oversight of Engineering, Validation, and IT activities supporting both clinical and commercial operations (including plant shutdowns) in a CDMO setting.

Support administration of the Change Control system through QA review and approval of change controls and identifying related continuous improvement opportunities.

Work directly with Validation and Facilities Engineering to review and approve GMP documentation developed to support the delivery of key capital projects and facilitate the ongoing lifecycle management defined by the Validation program. Track and report review and approval metrics.

Provides general QA support as Quality Engineering for Facilities/Engineering (incl. Calibration), Validation, CSV, AFS, QC & Microbiology, Manufacturing, MS&T, Supply Chain, and IT departments - which includes review and approval of Deviation Investigations, CAPAs, procedures, etc. as required.

In conjunction with Validation functional areas, develops and manages all validation policies, procedures, and protocols. Works to continuously improve and streamline the validation processes.

Provides QA support by representing Quality Engineering in project core team meetings. Provide training to QA and other functional teams as required.

Senior Specialist: BS and 8+ years' experience or MS and 6+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.

Principal Specialist: BS and 10+ years' experience or MS and 8+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.