QA Specialist - Deviations & CAPAs
Company: KBI Biopharma Inc.
Posted on: May 26, 2023
The QA Specialists on the Deviations and CAPAs team will provide oversight for the startup and ongoing manufacturing operations at our new biopharmaceutical manufacturing facility. The individual will report to the QA Manager of Deviations and CAPAs.
The individual will be responsible for collaborating with Operations staff on timely resolution of departures from established standards. The ideal candidate will have experience providing quality oversight or supporting compliance activities for a commercial GMP facility. Additionally, experience with single use equipment and an understanding of upstream, downstream and/or manufacturing support biotechnology principles is desired. Willingness to learn by interacting with peers, Operations staff, and individually through document review is required. Must thoroughly grasp and be able to clearly present technical concepts. The Specialist should possess technical writing and problem-solving skills and a drive for continuous improvement.
This role will be responsible for collaborating with Operations teams on completion of thorough and robust manufacturing investigations, implementation of effective corrective/preventative actions, and manufacturing change controls. The individual is responsible for working cross-functionally with the Manufacturing, Engineering, Supply Chain, IT, QC and other key departments to ensure manufacturing operations are compliant with GxP requirements. This requires a drive for continuous improvement, simplicity and superior equipment and human performance.
Salary Range $67,000 - $85,000
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, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.
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.
Keywords: KBI Biopharma Inc., Durham , QA Specialist - Deviations & CAPAs, Other , Durham, North Carolina
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