Specialist / Senior specialist - QA operations

☞ KBI Biopharma

View: 150

Update day: 29-03-2024

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

Job Summary

Manage QA operations activities of the Manufacturing. Interact directly with clients and provide 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. Collaborate with manufacturing, supply chain and other internal stakeholders as needed to achieve site, operational and department goals. Cultivate and maintain Quality culture.

Job Responsibilities
  • Support master and executed batch record reviews/approvals for development programs, shop floor QA oversight, and the Deviation/CAPA system. Assure that department and company employees comply with required procedures
  • Ensure batch records, Deviations and CAPAs in support of manufacturing and drug substance batch release timelines are achieved
  • Review and approve master batch records and corresponding BOM’s in ASCTrac
  • Manage batch disposition timelines and reports metrics to Management
  • Support relevant investigations, change controls, CAPAs and raw material / consumable related projects
  • Facilitate communications between KBI and clients regarding product quality related events
  • Support manufacturing change controls as QA Subject Matter Expert, performing supplemental impact assessments and QA approvals as required
  • Track, trend, compile, and report client specific quality metrics and internal quality metrics as required. Specific data may be reported out at client meetings and internal Management Review meetings
  • Attend relevant operational meetings in support of Manufacturing operations and batch disposition activities.
  • Attend relevant operational meetings in support of Manufacturing operations and material / consumable disposition activities. Other activities as assigned by Management
  • Support client audits and regulatory inspections as required. Partners with Program Management, Manufacturing Science and Technology, Analytical and Formulation Services and Manufacturing Operations to provide QA support

Job Requirements
  • Bachelor or Master Degree in Life sciences or Quality
  • 5 years of experience in a QA cGMP regulated environment within the Biopharmaceutical industry
  • Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills
  • Experience in QA inspection / release of materials for cGMP / commercial or development manufacturing
  • Knowledge of US and EU cGMP requirements is necessary
  • 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: 13-05-2024

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