Job Title: Quality Systems Administration resource I Position Responsibilities
- Provides GMP Quality Assurance Support to Quality Technology (CTM and Commercial Readiness functions) by supporting the following activities:
- Clinical Trial Material Documentation review including:
- Review of Biologic Drug Substance Manufacturing Batch Records
- Review of CTM Labeling Executed Batch records
- Temperature Excursion Management
- Document Management and support of CTM QP release via upload to the document repository for biologic CTM release
- Management and review of Quality Agreements for CTM and Commercial Readiness functions
- Document Management and archival to support First of Code programs managed by Commercial Readiness
- BA / BS in a science or engineering related field, with a minimum of 2 years of pharmaceutical or Medical Device industry experience in either CMC, GMP, Process Validation, QC and/or QA.
- Knowledge of GMPs and other relevant regulations, as required, with a broad knowledge of quality principles and industry trends.
- Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the Company groups and with external stakeholders.
- Must be a self-starter, proactive and have the ability to manage department resources to achieve the desired outputs on a daily basis.
- Direct experience in Biologics manufacturing (Drug Substance, Drug Product)
- Experience using GxP Documentation systems (Such as ADMS or Documentum)
- In-depth know of global industry standards and regulatory requirements (e.g., US, EU and Japan).
- Direct experience in commercial readiness, CTM delivery, and / or QA.
- Applied knowledge in the areas of Biologics, Solid Dose, Parenteral, Medical Device, and / or Regenerative medicines.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.