QA Senior Specialist, Facilities & Compliance

Position Summary:

This individual supports all QA activities related to Facility Engineering and Validation in a contract manufacturing organization (CMO) setting. Execute QA review and approval of documentation to result in timely oversight of equipment, computer systems, utilities, and facilities to support start-up of a new commercial manufacturing programs and subsequent routine operations. This individual provides quality oversight of facility upgrades and expansions. This position will focus on supporting the computer system validation process as well as implementing a site data integrity program for pharmaceutical systems. QA experience in cGMP operations dealing with CSV and DI initiatives is required.   

Position Responsibilities:

• Leads implementation of site Data Integrity initiative and provides governance to ongoing DI initiatives.
• Perform QA review and approval of computer system validations, including for electronic batch records, manufacturing process control system, instrumentation and other CSV items.
• Provides quality support for Engineering, Validation and IT activities including both clinical and commercial operations in a contract manufacturing organization (CMO) setting. Works 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.
• Provide quality oversight of Validation activities supporting commercial operations in a contract manufacturing organization (CMO) setting. Works directly with Validation to review and approve GMP documentation developed to support the commercial manufacturing facility and facilitate the ongoing lifecycle management defined by the Validation program.  In conjunction with team and Validation functional areas, develops and manages all validation policies, procedures, and protocols. Works to continuously improve and streamline the validation processes.
• Supports the site change control system. Works directly with functional areas to review and approve change controls. Reviews change controls and assesses for Quality Impact. Works to continuously improve and streamline the change control system
• Provides general QA support for Facilities Engineering, Validation, Metrology, AFS, Manufacturing and IT departments, which includes review and approval of Change Controls, Calibration Alert Notifications, Gemba Walks, etc.
• Support process improvement projects to include streamlining and improving the lifecycle of CSV/DI initiatives and site review process.
• Able to react to change productively and handle other essential tasks as assigned.

Position Requirements:

• BS and 5+ years of experience or MS and 3+ years of experience (QA Specialist I/II) / BS and 8+ years of experience or MS and 5+ years of experience (QA Senior Specialist) in a QA role in a cGMP regulated environment within biopharmaceuticals or equivalent.
• Experience with computer system validation (CSV), Data Integrity (DI) and qualification of enterprise systems is required
• Working knowledge of FDA, EU and ROW cGMP regulations is required.
• Must demonstrate strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
• Experience in a commercial manufacturing environment is beneficial.
• Experience with computer validation and/ or qualification of enterprise systems is required.   

Salary Range: $84,000 - $115,000

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.   

About KBI: 

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com. 

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