KBI

KBI

KBI: US - Principal QA Specialist

USA - NC - Durham - Hamlin Rd · Principal

Sponsorship not specified$113k-$156kDetected 30 days ago
ComplianceProduct ManagementGMPFDA Regulatory

About the role

  • This individual is responsible for the compliance review of Biopharmaceutical GMP data.
  • This includes the review and approval of in-process, release, and stability test data.
  • The Principal QA 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.

Responsibilities

  • Provides QA support for Deviations, CAPAs, Laboratory Investigations, Change Controls and Projects related to laboratory processes, instruments, specifications, methods and SOPs.
  • Provides QA oversight of special projects such as implementation of new processes to support site, operational and department goals.
  • Serves as trainer/mentor for QA Specialists and cross-trainer for employees in other departments to support individual development goals.

Requirements

  • Bachelor's degree and 10+ years' experience or Master's degree and 6+ 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 details and excellent problem resolutions skills.
  • Strong understanding of FDA, EU and cGMP regulations is required.
  • Experience in Quality Control and Quality Systems is beneficial.

Compensation

  • $113,000-$156,000

Benefits

  • 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.

Company info

  • 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.

Equal opportunity

  • KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force.
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This listing is sourced directly from KBI's careers page and normalized into a canonical job model.