Job Description

Position Summary:

We are seeking a highly motivated QA Manufacturing Specialist I/II at our state of the art commercial manufacturing facility in Patriot Park, Durham, NC.

You will have the unique opportunity to help build our site processes and culture as we ramp up to full manufacturing capacity. We embrace KBI's values of learning and growth, high standards, collaboration, and trust and respect to solve problems and continuously improve. As a center of excellence, our site enables real-time quality and process monitoring through paperless records with integrated automation. We are looking for a critical thinker who is comfortable tackling new challenges / unknowns and utilizing a risk-based approach. We hope you join us!

Position Responsibilities:

• Be an on-the-floor quality partner working with the manufacturing team during operations
• Work with manufacturing and other groups to escalate and resolve deviations and other compliance issues
• Conduct QA walkthroughs
• Participate in safety walkthroughs
• Participate in process improvements
• Attend relevant meetings in support of manufacturing operations
• Review electronic batch records and logbooks
• Provide feedback on facility response for unplanned events
• Other tasks and projects as assigned
• Work 12-hour shifts (2-2-3 schedule, day shift)

Position Qualifications:

MQA Specialist I

• High School diploma or equivalent.
• Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years).
• Demonstrated ability to work in a team environment.
• Demonstrated ability to understand the manufacturing process.
• Ability to perform routine core MQA responsibilities.

MQA Specialist II

• Associate degree / bachelor's degree strongly preferred or appropriate years of experience (approximate 3-5 years).
• Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization.
• Demonstrated ability to represent Quality on interdepartmental meetings.
• Demonstrated knowledge of technical documents.
• Ability to support internal and external audits.
• Demonstrated ability to train employees on Quality subjects.
• Ability to track and trend department metrics

Salary Ranges:

MQA Specialist I: $54,000 - $74,300

MQA Specialist II: 66,966 - 92,077

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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