Senior QA Specialist, Facilities & Compliance

Position Summary

The Senior QA Specialist provides Quality Assurance oversight and support for Facilities Engineering Validation Cleaning Validation Metrology computerized systems and related GMP activities supporting clinical and commercial manufacturing operations.

This position partners with Engineering Facilities Validation Manufacturing MSAT IT and other cross-functional teams to provide science- and risk-based Quality oversight and ensure facilities utilities equipment systems and validated processes remain compliant and in a state of control throughout their lifecycle.

Key Responsibilities

• Provide QA oversight for GMP facilities utilities equipment Engineering Validation Cleaning Validation Metrology and computerized systems.
• Review and approve GMP documentation including qualification and validation protocols/reports cleaning validation documentation risk assessments deviations CAPAs change controls and return-to-service documentation.
• Provide QA oversight of commissioning qualification and validation activities including facility/utility and equipment qualification IQ/OQ/PQ process validation cleaning validation and computerized system validation as applicable.
• Support cleaning validation activities including validation strategies protocols/reports risk assessments sampling plans acceptance criteria worst-case assessments hold-time studies and lifecycle management.
• Assess qualification and validation impact associated with new products technology transfers facility/equipment/process changes and new client onboarding.
• Provide QA oversight of change controls and ensure appropriate qualification validation cleaning validation and GMP requirements are identified and addressed.
• Support facility upgrades capital projects shutdowns equipment modifications and commercial manufacturing readiness.
• Review and support investigations and CAPAs associated with facilities utilities equipment validation cleaning validation maintenance calibration and computerized systems.
• Support regulatory inspections client audits internal audits and inspection/PAI readiness activities.
• Identify and escalate Quality and compliance risks and partner with cross-functional teams to drive issues to resolution.
• Support continuous improvement of Quality qualification validation and change control processes.

Qualifications

• Bachelors degree with 8 years of relevant experience or Masters degree with 5 years of relevant experience in a QA role within a cGMP-regulated biopharmaceutical or equivalent environment.
• Experience reviewing and approving change controls deviations investigations and CAPAs.
• Knowledge of U.S. and EU cGMP regulations and guidelines is required.
• Experience supporting clinical and/or commercial biopharmaceutical manufacturing is preferred.
• Strong technical judgment problem-solving communication and cross-functional collaboration skills.
• Ability to independently manage multiple priorities and provide pragmatic risk-based Quality guidance in a fast-paced manufacturing environment.

Preferred Skills

• Experience supporting cleaning validation including protocols/reports risk assessments sampling strategies deviations and lifecycle activities.
• Experience providing QA oversight of commissioning qualification and validation activities for GMP facilities utilities equipment and computerized systems.
• Strong technical judgment problem-solving and risk-based decision-making skills.
• Strong technical writing communication and cross-functional collaboration skills.
• Ability to independently manage priorities and provide pragmatic Quality solutions in a fast-paced cGMP environment.

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.

I attest with my signature below that I have given to KBI Biopharma Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma Inc. to contact references provided for employment reference checks. If any information I have provided is untrue or if I have concealed material information I understand that this will constitute cause for the denial of employment or immediate dismissal.