KBI BioPharma
Senior Quality Assurance Specialist - Deviations / CAPAs
KBI BioPharma, Durham, North Carolina, United States, 27703
JOB SUMMARY
This Quality position collaborates with Manufacturing, MS&T, Facilities Engineering, Supply Chain, and IT to ensure completion of Root Cause Analysis, CAPAs and Effectiveness Checks (ECs) for Deviations according to cGMP requirements and the company's SOP. The role is directly responsible for review and approval of Deviations, CAPAs and ECs and provides the support for timely review of events for classification, initiation in EtQ and closure, along with facilitation of external client review and resolution of client comments. The individual in this position writes Deviation investigations and provide metrics to management as requested and mentors QA staff in deviation/CAPA review and approval to include training and certification of QA approvers. The position participates on cross-functional teams that regularly collaborate to improve the Deviation/CAPA system, supports development of training materials and training personnel, and supports Audits and Regulatory Inspections as required. Responsible for review and approval of Deviations and CAPAs in support of GMP manufacturing operations. Support timely review of events for classification, initiation in EtQ and closure. Support external client review and resolution of comments for assigned deviations and CAPAs as needed. Mentors junior QA staff in deviation/CAPA review and approval to include training and certification of QA approvers. Provide metrics to management as requested. JOB RESPONSIBILITIES
Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner. Review and approve Deviations and CAPAs. Works directly with manufacturing, facilities, and other departments responsible for GMP activities to support resolution of deviations and other compliance issues in a timely manner in support of batch release activities. Provides training for Deviation and CAPA TRNs to KBI staff. Collaborate with functional areas to improve the Deviation/CAPA system to include support in development of training materials and training personnel. Works to streamline these processes. Supports the generation of metrics, trends and project specific status updates of Deviations and CAPAs. Attend relevant operational and project meetings. Support client audits and regulatory inspections as required. MINIMUM REQUIREMENTS
Minimum BS in scientific field with 14+ years' experience or MS and 11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent. Experience with Quality Systems to include Batch Record review, supporting investigations and CAPAs. Knowledge of US, EU and Row cGMP guidelines required.
Salary Range 80,000 - 100,000
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.
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.
This Quality position collaborates with Manufacturing, MS&T, Facilities Engineering, Supply Chain, and IT to ensure completion of Root Cause Analysis, CAPAs and Effectiveness Checks (ECs) for Deviations according to cGMP requirements and the company's SOP. The role is directly responsible for review and approval of Deviations, CAPAs and ECs and provides the support for timely review of events for classification, initiation in EtQ and closure, along with facilitation of external client review and resolution of client comments. The individual in this position writes Deviation investigations and provide metrics to management as requested and mentors QA staff in deviation/CAPA review and approval to include training and certification of QA approvers. The position participates on cross-functional teams that regularly collaborate to improve the Deviation/CAPA system, supports development of training materials and training personnel, and supports Audits and Regulatory Inspections as required. Responsible for review and approval of Deviations and CAPAs in support of GMP manufacturing operations. Support timely review of events for classification, initiation in EtQ and closure. Support external client review and resolution of comments for assigned deviations and CAPAs as needed. Mentors junior QA staff in deviation/CAPA review and approval to include training and certification of QA approvers. Provide metrics to management as requested. JOB RESPONSIBILITIES
Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner. Review and approve Deviations and CAPAs. Works directly with manufacturing, facilities, and other departments responsible for GMP activities to support resolution of deviations and other compliance issues in a timely manner in support of batch release activities. Provides training for Deviation and CAPA TRNs to KBI staff. Collaborate with functional areas to improve the Deviation/CAPA system to include support in development of training materials and training personnel. Works to streamline these processes. Supports the generation of metrics, trends and project specific status updates of Deviations and CAPAs. Attend relevant operational and project meetings. Support client audits and regulatory inspections as required. MINIMUM REQUIREMENTS
Minimum BS in scientific field with 14+ years' experience or MS and 11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent. Experience with Quality Systems to include Batch Record review, supporting investigations and CAPAs. Knowledge of US, EU and Row cGMP guidelines required.
Salary Range 80,000 - 100,000
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.
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.