Specialist/Senior Specialist, QA Analytical

☞ KBI Biopharma

View: 149

Update day: 24-04-2024

Location: Plan-les-Ouates Genève GE

Category: IT - Software

Industry: Biotechnology Research

Position: Mid-Senior level

Job type: Full-time

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Job content

Position Summary:

This individual will be responsible for review and QA disposition of data for in process and finished bulk drug substance intended for cGMP use. Provides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations and laboratory deviations. The QA Analytical Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. Collaborates with laboratories, manufacturing, QA batch disposition and other internal stakeholders as needed to achieve site, operational and department specific goals. Cultivates and maintains Quality culture.

Position Responsibilities:
  • Performs timely review and QA disposition of test data for in process and finished bulk drug substance samples. Performs timely review of test results and documentation for stability studies associated with finished bulk drug substance and drug product. Assures activities comply with required procedures, cGLP and cGMP requirements.
  • Responsible for the review and approval of method verification, transfer, qualification, and validation related to the testing of in process samples, finished bulk drug substance, and drug product intended for cGMP use.
  • Provides QA support for Investigations, Deviations, CAPAs, Change Controls and Projects related to laboratory processes, instruments, specifications, methods and SOPs associated with testing of in process samples and finished bulk drug substance intended for cGMP use as well as stability studies.
  • Attends relevant operational meetings in support of Manufacturing operation, analysis and disposition activities for bulk drug substance. Supports client audits and regulatory inspections as required. Other activities as assigned by Management.

Minimum Requirements:
  • Bachelor’s degree and 6+ years’ experience or Master’s degree and 4+ years’ experience in a QA, QC or cGMP environment in Biopharmaceuticals or equivalent.
  • Demonstrated strong interpersonal skills, ability to work in a team environment, attention to detail and excellent problem resolutions skills. Strong understanding of FDA, EU and ROW cGMP regulations is required.
  • Experience in Quality Systems, Quality Control and release of biopharmaceuticals for cGMP use is beneficial.
  • Fluent in French and English

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.
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Deadline: 08-06-2024

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