Principal Qa Specialist, Facility Support

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 facility and subsequent routine operations. This individual provides quality oversight of facility upgrades and expansions and is responsible for managing the change control system. QA experience in commercial operations is preferred.

• Provides QA oversight of the 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 .
• 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 start-up of a new commercial manufacturing facility and facilitate the ongoing lifecycle management defined by the Validation program.
• In conjunction with Validation functional areas, develops and manages all validation policies, procedures, and protocols.
• Provides general QA support for Facilities Engineering, Validation, Metrology, CSV, and IT departments, which includes review and approval of Deviation Investigations, CAPAs, Calibration Alert Notifications, procedures, etc. .

Requirements:

• BS in life sciences (Biology, Chemistry preferred) or a combination of education and experience.
• A minimum of Ten (10) years' experience in the pharmaceutical or biopharmaceutical industry required.
• Experience in change control management required. Solid experience managing and executing Quality Systems. Additional experience in Quality Review and Approval of equipment and system validation documentation, calibration classification and compliance is required.

Salary Range: $110,000 - $130,000
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, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.
I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.
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