Job Summary:
The Quality Assurance Principal Specialist is responsible for performing activities associated with client quality activities. Facilitates communications between KBI and clients in regard to critical quality related events. This position interacts directly with clients and provides exemplary customer service to both internal and external customers by focusing on quality and compliance. This position reports to the Director of Quality Assurance.
Job Responsibilities:
* Represents Quality in required client meetings, which includes obtaining client metrics and presenting in client meetings.
* Performs review of Deviations, CAPAs, CCs, SOPs, and Technical Documents as needed to meet client delivery dates and expectations.
* Partners with Program Management, Manufacturing Sciences and Technology, Technical Services, Quality Assurance Analytical, Manufacturing, and AFS (QC) to provide support, align facility representation, and provide consistent quality information.
* Reviews, identifies, prioritizes, and implements or coordinates change improvement to people and/or processes to ensure compliance with regulatory and organization policies/procedures and to maximize process efficiency and conformance.
* Supports complaint investigations, annual product reviews for commercial clients.
Requirements:
* Bachelor's degree in pharmaceutical science, biology, chemistry, or related science.
* 10 years of work experience in pharmaceutical, Biological, Quality Assurance.
* Requires thorough knowledge of GMP guidelines as they relate to quality systems and compliance.
* Experience and knowledge of worldwide regulatory requirements with emphasis on regulatory requirements for biotechnology-derived product.
* Experience managing data, metrics, and presenting to senior management.
* Demonstrate strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem resolution sills.
Also requires a demonstrated track record in the following key areas:
* Strong orientation for Quality and Customer Service
* Demonstrated level of respect for individuals
* High level of integrity and personal responsibility
* Record of innovation
* Strong collaboration and team building skills
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.
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.
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