QA Specialist, SQM

Position Summary:

Assures that suppliers and raw materials are suitable for their intended use in the manufacture of clinical and commercial biologics bulk drug substance.Responsible for compliance with regulations, procedures, and systems that govern the supplier approval and material qualification programs.Supports client audits and regulatory inspections.

Position Description:

SQM assists with processing client projects for material qualification plans. The duties require review of the listed materials and alignment with material profiles in the supplier quality management function in EtQ, participation in project meetings, review and upload of material qualification data in EtQ, approval of material profiles, and periodic review of material profiles associated with assigned projects.

• Capture and enter vendor change notifications (VCN) in EtQ, initiating assessments, socializing the VCN with affected departments, collecting site Quality feedback, informing the client of changes that affect their product and managing the VCN to completion.
• Process material and supplier requests in EtQ as assigned following applicable Standard Operating Procedures (SOP). Manage the material profiles to completion.
• Initiates and owns Deviations, CAPA's, and Change Controls as appropriate.
• Negotiate and maintain supplier Quality Agreements
• Perform routine and for-cause supplier audits (desk and onsite) as assigned

Position Requirements:

Bachelor's degree and 5 years experience or Master's and 3 years' experience in a QA or cGMP environment in biopharmaceuticals or equivalent, including previous pharmaceutical supplier quality experience.

• Experience performing cGMP internal audits and/or supplier audits. Auditor certification (CQA or equivalent) preferred.
• Cross-site, inter and intra departmental project management experience and experience with electronic document management systems desired.

Position Location: This position is available for hire in USA or in Switzerland.

• For Geneva site, please note that due to the position's location, we can only consider candidates with European passports or Swiss working permits/citizenship.

Salary Range: $54,000 - $74,300 USD

Compensation will be adjusted for candidates in Switzerland.

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.

***Job up***

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.