Perform tactical work and review a variety of documents, protocols, and reports.
Project Details:
Exhibit varying levels of experience and a solid progression of work and/or training
Document, review and batch disposition of API and drug product used in Phase 1-3 clinical studies
Review and approve manufacturing records, change controls, investigations and analytical data
Review and approve test methods and method validations
Review manufacturing validation protocol and reports
Job Experience:
Experience in small molecule manufacturing and contract manufacturing
Bachelor's degree in Engineering, Chemistry, Biology, or other related discipline
A minimum of 5+ years' work experience in the Quality organization of a Medical Device and/or Pharmaceutical company
Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring, Manufacturing operation, etc.
Excellent verbal and written communication skills
Demonstrate ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical
Strong analytical skills
Effective project management and organizational skills are essential
Knowledge and understanding of quality
Manufacturing processes and procedures, planning, supply chain, inventory management
Oxford is an Equal Employment Opportunity Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford provides supplemental medical (we do not offer major medical), dental, vision, life, and disability benefit plans along with a 401(k) Retirement Savings Plan. Paid holidays based on eligibility and paid sick leave for applicable jurisdiction, as required. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email oxfordbenefitsgroup@oxfordcorp.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis.
