Quality Assurance Consultant

Oxford Global Resources; Lebanon (IN); On-site; USD 73,000 - 95,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) retirement plan

Paid holidays and sick leave

Job summary

Oxford is seeking a quality-focused professional to perform tactical work and review a variety of documents, protocols, and reports for API and drug product used in clinical studies.

You will review manufacturing records, change controls, investigations, analytical data, test methods, and validation protocols, collaborating with cross-functional teams to ensure compliant, timely documentation.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, or related discipline.
• 5+ years of work experience in Quality within Medical Device and/or Pharmaceutical companies.
• Experience with CAPA, root cause investigation, validation (process, test method, software, design).
• Knowledge of Environmental Monitoring, manufacturing operations, planning, and supply chain.

Responsibilities

• Document, review and batch disposition of API and drug product for Phase 1-3 studies.
• 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.

Skills

Small molecule manufacturing

Contract manufacturing

Analytical skills

Communication skills

Project management

Quality systems knowledge

Education

Bachelor's degree in Engineering/ Chemistry/ Biology

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: 53-69

Language Required: EnglishOxford

Company Benefits

• 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.

Company Commitment

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 [e-mail]. We will make a determination on your request for reasonable accommodation on a case-by-case basis.