Quality Assurance Consultant

Oxford Global Resources; Blue Ash (OH); On-site; USD 50,000 - 65,000; Full time

Job summary

Oxford Global Resources seeks an experienced Quality professional to conduct tactical reviews of manufacturing records, change controls and investigations, and to approve analytical data for Phase 1–3 clinical studies. The role requires a strong background in CAPA, root-cause investigations, and various validations.

Candidates should have a minimum of 5+ years in the quality organization of a Medical Device or Pharmaceutical company, and possess excellent communication and project management

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related discipline.
• 5+ years' experience in the Quality organization of a Medical Device/Pharma company.
• Knowledge of CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring, Manufacturing operations.

Responsibilities

• Review and approve manufacturing records, change controls, investigations and analytical data.
• Review and approve test methods and method validations.
• Review manufacturing validation protocols and reports.
• Document, review and batch disposition of API and drug product used in Phase 1-3 clinical studies.

Skills

Quality management

Analytical skills

Project management

Communication skills

Education

Bachelor's degree in Engineering

Background in Chemistry or Biology

Tools

CAPA systems

Root cause analysis

Process validation

Software validation

Job description

Summary: 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

Hourly Rate: 36-47Oxford 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 [e-mail]. We will make a determination on your request for reasonable accommodation on a case-by-case basis.